ORCID Profile
0000-0002-0490-7465
Current Organisations
Australian Division of World Action on Salt and Health
,
American Heart Association Inc
,
Royal Prince Alfred Hospital
,
Royal College of Physicians
,
Imperial College London
,
The George Institute for Global Health/UNSW
,
UNSW Sydney
,
Monash University
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Publisher: Elsevier BV
Date: 11-2020
Publisher: Public Library of Science (PLoS)
Date: 26-03-2013
Publisher: BMJ
Date: 24-02-2020
DOI: 10.1136/BMJ.M315
Abstract: To examine the dose-response relation between reduction in dietary sodium and blood pressure change and to explore the impact of intervention duration. Systematic review and meta-analysis following PRISMA guidelines. Ovid MEDLINE(R), EMBASE, and Cochrane Central Register of Controlled Trials (Wiley) and reference lists of relevant articles up to 21 January 2019. Randomised trials comparing different levels of sodium intake undertaken among adult populations with estimates of intake made using 24 hour urinary sodium excretion. Two of three reviewers screened the records independently for eligibility. One reviewer extracted all data and the other two reviewed the data for accuracy. Reviewers performed random effects meta-analyses, subgroup analyses, and meta-regression. 133 studies with 12 197 participants were included. The mean reductions (reduced sodium v usual sodium) of 24 hour urinary sodium, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were 130 mmol (95% confidence interval 115 to 145, P .001), 4.26 mm Hg (3.62 to 4.89, P .001), and 2.07 mm Hg (1.67 to 2.48, P .001), respectively. Each 50 mmol reduction in 24 hour sodium excretion was associated with a 1.10 mm Hg (0.66 to 1.54 P .001) reduction in SBP and a 0.33 mm Hg (0.04 to 0.63 P=0.03) reduction in DBP. Reductions in blood pressure were observed in erse population subsets examined, including hypertensive and non-hypertensive in iduals. For the same reduction in 24 hour urinary sodium there was greater SBP reduction in older people, non-white populations, and those with higher baseline SBP levels. In trials of less than 15 days’ duration, each 50 mmol reduction in 24 hour urinary sodium excretion was associated with a 1.05 mm Hg (0.40 to 1.70 P=0.002) SBP fall, less than half the effect observed in studies of longer duration (2.13 mm Hg 0.85 to 3.40 P=0.002). Otherwise, there was no association between trial duration and SBP reduction. The magnitude of blood pressure lowering achieved with sodium reduction showed a dose-response relation and was greater for older populations, non-white populations, and those with higher blood pressure. Short term studies underestimate the effect of sodium reduction on blood pressure. PROSPERO CRD42019140812.
Publisher: Ubiquity Press, Ltd.
Date: 13-07-2021
DOI: 10.5334/GH.913
Publisher: Elsevier BV
Date: 07-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2009
Publisher: Elsevier BV
Date: 09-2021
Publisher: Elsevier BV
Date: 02-2013
Publisher: MDPI AG
Date: 26-04-2020
DOI: 10.3390/NU12051216
Abstract: The Australian population consumes more salt than recommended and this increases the risk of raised blood pressure and cardiovascular disease. In 2015, a state-wide initiative was launched in the Australian state of Victoria to reduce population salt intake. This study examines whether salt-related knowledge, attitudes and behaviors (KABs) of Victorian adults changed following the first 22 months of a consumer awareness c aign targeting parents. Repeated cross-sectional surveys of adults (18–65 years) recruited from research panels. Analyses were weighted to reflect the Victorian population. In both surveys mean age of participants (1584 in 2015 and 2141 in 2018) was 41 years, and 51% were female. This includes 554 parents/caregivers in 2015 and 799 in 2018. Most indicators of KAB remained unchanged. Among parents/caregivers the percentage who agreed limiting salt in their child’s diet was important increased by 8% (p = 0.001), and there was a 10% reduction in the percentage who reported placing a saltshaker on the table and a 9% reduction in those who reported their child added salt at the table (both p 0.001). Some small adverse effects on other indicators were also observed. During the first 22 months of a salt reduction consumer awareness c aign, there were limited changes in KAB overall, however the target audience reported positive changes regarding their children, which aligned with the c aign messages.
Publisher: Cambridge University Press (CUP)
Date: 18-07-2013
DOI: 10.1017/S1368980013001791
Abstract: To assess the change in Na content of Australian pasta sauces between 2008 and 2011. A secondary objective was to project the mean Na content of these same products in 2014 using the Australian Food and Health Dialogue Na commitment and compare projections with the 2012 UK Na target for pasta sauce. Na data were collected from the product labels of pasta sauce products. Mean Na content was calculated for 2008 and 2011 and change assessed. Projected mean values for 2014 were derived by applying a 15 % reduction to the 2011 products above the ‘action point’ of 420 mg Na/100 g, consistent with the Food and Health Dialogue commitment (scenario 1). A 15 % reduction was applied to products already below the ‘action point’ (scenario 2). Projections were compared with the 2012 UK target. Na data for pasta sauce products in Australian supermarkets (July–September) in 2008 and 2011. Not applicable. Data were available for 124 (2008) and 187 (2011) products, and mean Na levels were not significantly different (451 mg/100 g v . 423 mg/100 g P = 0·16). The projected means (381 mg Na/100 g in scenario 1 375 mg Na/100 g in scenario 2) exceeded the 2012 UK target (330 mg Na/100 g) and to attain this would require a 22 % reduction from 2011 levels. There is little evidence that all Australian manufacturers of pasta sauces systematically reduced the Na content of their products between 2008 and 2011. Even if all manufacturers achieve the current voluntary commitment by 2014, average salt levels in Australian products would still be above the 2012 UK target.
Publisher: Springer Science and Business Media LLC
Date: 14-06-2023
DOI: 10.1186/S12966-023-01475-5
Abstract: The Victorian Salt Reduction Partnership (VSRP) implemented a media advocacy strategy (intervention) to stimulate food manufacturers to reduce sodium levels across targeted Australian packaged foods between 2017 and 2019. This study assessed changes in sodium levels of targeted and non-targeted packaged foods during the intervention (2017 to 2019) compared to before the intervention (2014 to 2016) in Australia. Annually collected branded-food composition data from 2014 to 2019 were used. Interrupted time series analyses was conducted to compare the trend in sodium levels in packaged foods during the intervention (2017–2019) to the trend in the pre-intervention period (2014–2016). The difference between these trends was derived to estimate the effect of the intervention. A total of 90,807 products were included in the analysis, of which 14,743 were targeted by the intervention. The difference in before and during intervention trends between targeted and non-targeted food categories was 2.59 mg/100 g (95% CI: -13.88 to 19.06). There was a difference in the pre-intervention slope (2014, 2015, 2016) and intervention slope (2017, 2018, 2019) for four of 17 targeted food categories. There was a decrease in sodium levels (mg/100 g) in one food category: frozen ready meals (-13.47 95% CI: -25.40 to -1.53), and an increase in three categories: flat bread (20.46 95% CI: 9.11 to 31.81), plain dry biscuits (24.53 95% CI: 5.87 to 43.19), and bacon (44.54 95% CI: 6.36 to 82.72). For the other 13 targeted categories, the difference in slopes crossed the line of null effect. The VSRP’s media advocacy strategy did not result in a meaningful reduction in sodium levels of targeted packaged food products during the intervention years compared to trends in sodium levels before the intervention. Our study suggests media advocacy activities highlighting the differences in sodium levels in packaged food products and industry meetings alone are not sufficient to lower average sodium levels in packaged foods in the absence of government leadership and measurable sodium targets.
Publisher: AMPCo
Date: 12-2014
DOI: 10.5694/MJA14.00266
Abstract: To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk. A within-trial cost analysis of polypill-based care versus usual care with separate medications, using data from the Kanyini Guidelines Adherence with the Polypill (GAP) trial and linked health service and medication administrative claims data. Kanyini GAP participants who consented to Australian Medicare record access. Mean health service and pharmaceutical expenditure per patient per year, estimated with generalised linear models. Costs during the trial (randomisation January 2010 - May 2012, median follow-up 19 months, maximum follow-up 36 months) were inflated to 2012 costs. Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $989 (95% CI, $648-$1331) per patient per year in the polypill arm compared with usual care (P < 0.001 adjusted, excluding polypill cost). No significant difference was shown in health service expenditure. This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy. The savings will be less now than during the trial due to subsequent reductions in the costs of usual care. Nonetheless, given the prevalence of CVD in Australia, the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia. Australian New Zealand Clinical Trials Registry ACTRN126080005833347.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-11-2019
Publisher: Springer Science and Business Media LLC
Date: 31-10-2013
DOI: 10.1007/S11906-013-0389-5
Abstract: There is unequivocal evidence that increased sodium intake is associated with increased blood pressure, and that increased blood pressure leads to increased risk of vascular diseases. Unfortunately, the published evidence directly linking sodium intake to vascular risk is inconsistent and confusing. This review, emphasising recent developments in national and international settings, considers why this is the case and how vested interests - particularly the food industry - have exploited the vacuum. We argue that legislation is the only tool that is likely to reverse the current situation wherein many millions of lives are put at risk through an unnecessary dietary additive, the reduction of which would be eminently feasible and have no conceivable disadvantage to health.
Publisher: Wiley
Date: 05-1996
DOI: 10.1111/J.1440-1681.1996.TB02758.X
Abstract: 1. Among patients with cerebrovascular disease, there is a direct and continuous association between blood pressure and the risk of stroke, but previous trials of blood pressure lowering in this patient group have been inconclusive. 2. PROGRESS (Perindopril Protection Against Recurrent Stroke Study) is a multicentre, randomized, placebo-controlled trial that aims to determine reliably the effect of angiotensin converting enzyme (ACE) inhibitor-based blood pressure lowering on stroke risk in patients with a history of cerebrovascular disease. If a 4 week run-in period on active perindopril is well tolerated, participants are randomized to either perindopril (4 mg) +/- indapamide (2.5 mg) or matching placebo(s). The primary study outcome is stroke and follow-up is for a minimum of 4 years. 3. For the pilot study nearly 5000 medical records were screened and 60 patients with recent cerebrovascular events were approached directly in hospital or at a clinic visit. Sixty-seven patients entered the run-in phase (52 from retrospective screening and 15 by prospective approach) and 60 patients proceeded to randomization. Treatment with perindopril was well tolerated only three patients were withdrawn due to side effects and four were withdrawn for other reasons. The mean age of randomized patients was 68 years 70% were male and 55% were 'non-hypertensive'. The mean entry blood pressure was 142/83 mmHg and following pre-randomization treatment this was reduced by 7/4 mmHg. 4. Most patients were identified by retrospective review of medical records, but this was less efficient than prospective methods. Blood pressure lowering was well tolerated by both hypertensive and non-hypertensive patients with cerebrovascular disease. The small numbers of patients and the non-randomized nature of the data reported limit the conclusions that can be drawn, but the results confirm the feasibility of the main study.
Publisher: BMJ
Date: 26-07-2023
DOI: 10.1136/HEARTJNL-2022-322300
Abstract: To determine the cost-effectiveness and cost-utility of a quadpill containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg in comparison with irbesartan 150 mg for people with hypertension who are either untreated or receiving monotherapy. We conducted a within-trial and modelled economic evaluation of the Quadruple UltrA-low-dose tReaTment for hypErTension trial. The analysis was preplanned, and medications and health service use captured during the trial. The main outcomes were incremental cost-effectiveness ratios (ICERs) for cost per mm Hg systolic blood pressure (BP) reduction at 3 months, and modelled cost per quality-adjusted life year (QALY) over a lifetime. The within-trial analysis showed no clear difference in cost per mm Hg BP lowering between randomised treatments at 3 months ($A10 (95% uncertainty interval (UI) $A −18 to $A37) per mm Hg per person) for quadpill versus monotherapy. The modelled cost-utility over a lifetime projected a mean incremental cost of $A265 (95% UI $A166 to $A357) and a mean 0.02 QALYs gained (95% UI 0.01 to 0.03) per person with quadpill therapy compared with monotherapy. Quadpill therapy was cost-effective in the base case (ICER of $A14 006 per QALY), and the result was sensitive to the quadpill cost in one-way sensitivity analysis. Quadpill in comparison with monotherapy is comparably cost-effective for short-term BP lowering. In the long-term, quadpill therapy is likely to be cost-effective. ANZCTRN12616001144404.
Publisher: BMJ
Date: 09-08-2022
DOI: 10.1136/HEARTJNL-2022-321332
Abstract: The Salt Substitute and Stroke Study (SSaSS) recently reported blood pressure-mediated benefits of a potassium-enriched salt substitute on cardiovascular outcomes and death. This study assessed the effects of salt substitutes on a breadth of outcomes to quantify the consistency of the findings and understand the likely generalisability of the SSaSS results. We searched PubMed, Embase and the Cochrane Library up to 31 August 2021. Parallel group, step-wedge or cluster randomised controlled trials reporting the effect of salt substitute on blood pressure or clinical outcomes were included. Meta-analyses and metaregressions were used to define the consistency of findings across trials, geographies and patient groups. There were 21 trials and 31 949 participants included, with 19 reporting effects on blood pressure and 5 reporting effects on clinical outcomes. Overall reduction of systolic blood pressure (SBP) was −4.61 mm Hg (95% CI −6.07 to −3.14) and of diastolic blood pressure (DBP) was −1.61 mm Hg (95% CI −2.42 to −0.79). Reductions in blood pressure appeared to be consistent across geographical regions and population subgroups defined by age, sex, history of hypertension, body mass index, baseline blood pressure, baseline 24-hour urinary sodium and baseline 24-hour urinary potassium (all p homogeneity .05). Metaregression showed that each 10% lower proportion of sodium choloride in the salt substitute was associated with a −1.53 mm Hg (95% CI −3.02 to −0.03, p=0.045) greater reduction in SBP and a −0.95 mm Hg (95% CI −1.78 to −0.12, p=0.025) greater reduction in DBP. There were clear protective effects of salt substitute on total mortality (risk ratio (RR) 0.89, 95% CI 0.85 to 0.94), cardiovascular mortality (RR 0.87, 95% CI 0. 81 to 0.94) and cardiovascular events (RR 0.89, 95% CI 0.85 to 0.94). The beneficial effects of salt substitutes on blood pressure across geographies and populations were consistent. Blood pressure-mediated protective effects on clinical outcomes are likely to be generalisable across population subgroups and to countries worldwide. CRD42020161077.
Publisher: BMJ
Date: 07-2001
DOI: 10.1136/EBM.6.4.111
Publisher: Elsevier BV
Date: 08-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 27-07-2004
DOI: 10.1161/01.CIR.0000136583.52681.0D
Abstract: Background— Cardiovascular disease has become the leading cause of death in China. We examined the levels of serum total and lipoprotein cholesterol and status of awareness, treatment, and control of hypercholesterolemia in China. Methods and Results— A cross-sectional survey in a nationally representative s le of 15 540 Chinese adults 35 to 74 years of age was conducted during 2000 to 2001. Serum cholesterol was measured by use of standard methods, and information on treatment of hyperlipidemia was obtained by use of a standard questionnaire. Age-standardized mean levels of total, HDL, and LDL cholesterol and triglycerides were 186.1, 51.7, 109.5, and 128.1 mg/dL, respectively. Of the Chinese population 35 to 74 years of age, 23.8% (112 500 000 persons) had borderline high total cholesterol (200 to 239 mg/dL), and 9.0% (42 540 000 persons) had high total cholesterol (≥240 mg/dL). The population estimates for borderline high (130 to 159 mg/dL), high (160 to 189 mg/dL), and very high (≥190 mg/dL) LDL cholesterol were 17.0% (80 122 000 persons), 5.1% (24 329 000 persons), and 2.7% (12 822 000 persons), respectively. In addition, 19.2%, or 90 803 000 persons, had a low HDL cholesterol ( mg/dL). Among those who had a total cholesterol ≥200 mg/dL or who were on cholesterol-lowering medications, the proportion of men and women who were aware, treated, and controlled was only 8.8% and 7.5%, 3.5% and 3.4%, and 1.9% and 1.5%, respectively. Conclusions— The prevalence of hypercholesterolemia was relatively high and the percentage of adults with controlled blood cholesterol was low in China. Prevention and treatment of hypercholesterolemia should be an important component of a national strategy to reduce the substantial and increasing burden of cardiovascular disease in China.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 17-09-2019
Abstract: Albuminuria commonly occurs in people with type 2 diabetes and is an independent risk factor for progression of kidney disease and cardiovascular events. SGLT2 inhibitors are thought to protect the kidneys by lowering albuminuria. If this is true, it suggests people with type 2 diabetes with higher levels of albuminuria would reap greater renoprotective benefits. The authors conducted a post-hoc analysis of data from the CANagliflozin cardioVascular Assessment Study (CANVAS) Program to assess renal, cardiovascular, and safety outcomes with canagliflozin by baseline albuminuria subgroups (urinary albumin/creatinine ratio , 30–300, and mg/g). The data suggest that the relative effects of canagliflozin on renal and cardiovascular outcomes are mostly consistent across different levels of baseline albuminuria, but participants with severely increased albuminuria saw the largest absolute benefits. If SGLT2 inhibitors protect the kidneys by reducing albuminuria as hypothesized, people with type 2 diabetes mellitus (T2DM) with higher albuminuria should benefit more. We conducted a post-hoc analysis of data from the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, which randomized 10,142 participants with T2DM and high cardiovascular risk to canagliflozin or placebo. We assessed effects of canagliflozin on renal, cardiovascular, and safety outcomes by baseline albuminuria. The trial included 2266 participants (22.3%) with moderately increased albuminuria (urinary albumin/creatinine ratio [UACR] 30–300 mg/g) and 760 (7.5%) with severely increased albuminuria (UACR mg/g) at baseline. Canagliflozin lowered albuminuria with greater proportional reductions in those with moderately and severely increased albuminuria ( P heterogeneity .001). After week 13, canagliflozin slowed the annual loss of kidney function across albuminuria subgroups, with greater absolute reductions in participants with severely increased albuminuria (placebo-subtracted difference 3.01 ml/min per 1.73 m 2 per year P heterogeneity .001). Heterogeneity for the renal composite outcome of 40% reduction in eGFR, ESKD, or renal-related death was driven by lesser effects in participants with moderately increased albuminuria ( P heterogeneity=0.03), but no effect modification was observed when albuminuria was fitted as a continuous variable ( P heterogeneity=0.94). Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for utation across albuminuria subgroups ( P heterogeneity=0.66). Greater absolute risk reductions in the renal composite outcome were observed in participants with severely increased albuminuria ( P heterogeneity=0.004). The proportional effects of canagliflozin on renal and cardiovascular outcomes are mostly consistent across patients with different levels of albuminuria, but absolute benefits are greatest among those with severely increased albuminuria.
Publisher: American Medical Association (AMA)
Date: 10-01-2017
Abstract: Elevated systolic blood (SBP) pressure is a leading global health risk. Quantifying the levels of SBP is important to guide prevention policies and interventions. To estimate the association between SBP of at least 110 to 115 mm Hg and SBP of 140 mm Hg or higher and the burden of different causes of death and disability by age and sex for 195 countries and territories, 1990-2015. A comparative risk assessment of health loss related to SBP. Estimated distribution of SBP was based on 844 studies from 154 countries (published 1980-2015) of 8.69 million participants. Spatiotemporal Gaussian process regression was used to generate estimates of mean SBP and adjusted variance for each age, sex, country, and year. Diseases with sufficient evidence for a causal relationship with high SBP (eg, ischemic heart disease, ischemic stroke, and hemorrhagic stroke) were included in the primary analysis. Mean SBP level, cause-specific deaths, and health burden related to SBP (≥110-115 mm Hg and also ≥140 mm Hg) by age, sex, country, and year. Between 1990-2015, the rate of SBP of at least 110 to 115 mm Hg increased from 73 119 (95% uncertainty interval [UI], 67 949-78 241) to 81 373 (95% UI, 76 814-85 770) per 100 000, and SBP of 140 mm Hg or higher increased from 17 307 (95% UI, 17 117-17 492) to 20 526 (95% UI, 20 283-20 746) per 100 000. The estimated annual death rate per 100 000 associated with SBP of at least 110 to 115 mm Hg increased from 135.6 (95% UI, 122.4-148.1) to 145.2 (95% UI 130.3-159.9) and the rate for SBP of 140 mm Hg or higher increased from 97.9 (95% UI, 87.5-108.1) to 106.3 (95% UI, 94.6-118.1). For loss of DALYs associated with systolic blood pressure of 140 mm Hg or higher, the loss increased from 95.9 million (95% uncertainty interval [UI], 87.0-104.9 million) to 143.0 million (95% UI, 130.2-157.0 million) [corrected], and for SBP of 140 mm Hg or higher, the loss increased from 5.2 million (95% UI, 4.6-5.7 million) to 7.8 million (95% UI, 7.0-8.7 million). The largest numbers of SBP-related deaths were caused by ischemic heart disease (4.9 million [95% UI, 4.0-5.7 million] 54.5%), hemorrhagic stroke (2.0 million [95% UI, 1.6-2.3 million] 58.3%), and ischemic stroke (1.5 million [95% UI, 1.2-1.8 million] 50.0%). In 2015, China, India, Russia, Indonesia, and the United States accounted for more than half of the global DALYs related to SBP of at least 110 to 115 mm Hg. In international surveys, although there is uncertainty in some estimates, the rate of elevated SBP (≥110-115 and ≥140 mm Hg) increased substantially between 1990 and 2015, and DALYs and deaths associated with elevated SBP also increased. Projections based on this s le suggest that in 2015, an estimated 3.5 billion adults had SBP of at least 110 to 115 mm Hg and 874 million adults had SBP of 140 mm Hg or higher.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2015
DOI: 10.1161/CIRCOUTCOMES.114.001235
Abstract: Despite effective treatments to reduce cardiovascular disease risk, their translation into practice is limited. Using a parallel arm cluster-randomized controlled trial in 60 Australian primary healthcare centers, we tested whether a multifaceted quality improvement intervention comprising computerized decision support, audit/feedback tools, and staff training improved (1) guideline-indicated risk factor measurements and (2) guideline-indicated medications for those at high cardiovascular disease risk. Centers had to use a compatible software system, and eligible patients were regular attendees (Aboriginal and Torres Strait Islander people aged ≥35 years and others aged ≥45 years). Patient-level analyses were conducted using generalized estimating equations to account for clustering. Median follow-up for 38 725 patients (mean age, 61.0 years 42% men) was 17.5 months. Mean monthly staff support was hour/site. For the coprimary outcomes, the intervention was associated with improved overall risk factor measurements (62.8% versus 53.4% risk ratio 1.25 95% confidence interval, 1.04–1.50 P =0.02), but there was no significant differences in recommended prescriptions for the high-risk cohort (n=10 308 56.8% versus 51.2% P =0.12). There were significant treatment escalations (new prescriptions or increased numbers of medicines) for antiplatelet (17.9% versus 2.7% P .001), lipid-lowering (19.2% versus 4.8% P .001), and blood pressure–lowering medications (23.3% versus 12.1% P =0.02). In Australian primary healthcare settings, a computer-guided quality improvement intervention, requiring minimal support, improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group. Computerized quality improvement tools offer an important, albeit partial, solution to improving primary healthcare system capacity for cardiovascular disease risk management. URL: www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336630 . Australian New Zealand Clinical Trials Registry No. 12611000478910.
Publisher: Wiley
Date: 07-03-2022
DOI: 10.1111/DOM.14671
Abstract: To define the proportional and absolute benefits of the sodium‐glucose co‐transporter‐2 inhibitor canagliflozin in patients with type 2 diabetes (T2D) with and without peripheral arterial disease (PAD). We pooled in idual participant data from the CANVAS Program (n = 10 142) and CREDENCE trial (n = 4401). In this post hoc analysis, the main outcomes of interest were major adverse cardiovascular events (MACE: non‐fatal myocardial infarction, non‐fatal stroke or cardiovascular death), kidney outcomes, and extended major adverse limb events (MALE). Cox proportional hazards models were used to assess canagliflozin treatment effects in those with and without PAD. Absolute risk reductions per 1000 patients treated for 2.5 years were estimated using Poisson regression. Of 14 543 participants, 3159 (21.7%) had PAD at baseline. In patients with PAD, canagliflozin reduced MACE (hazard ratio, 0.76 95% confidence interval, 0.62‐0.92), with similar relative benefits for other cardiovascular and kidney outcomes in participants with or without PAD at baseline (all P interaction .268). There was no increase in the relative risk of extended MALE with canagliflozin, irrespective of baseline PAD history ( P interaction .864). The absolute benefits of canagliflozin were greater in those with PAD. Patients with T2D and PAD derived similar relative cardiorenal benefits from canagliflozin treatment but higher absolute benefits compared with those without PAD, with no increase in extended MALE.
Publisher: Wiley
Date: 05-09-2013
Publisher: JMIR Publications Inc.
Date: 21-09-2016
DOI: 10.2196/RESPROT.6282
Publisher: Cambridge University Press (CUP)
Date: 07-07-2015
DOI: 10.1017/S1368980015001974
Abstract: To assess the mean package size and manufacturer-recommended serving size of sweet beverages available in four high-income countries: Australia, Canada, the Netherlands and New Zealand. Cross-sectional surveys. The two largest supermarket chains of each country in 2012/2013. In idual pack size (IPS) drinks ( n 891) and bulk pack size (BPS) drinks ( n 1904). For all IPS drinks, the mean package size was larger than the mean serving size (mean ( sd )=412 (157) ml and 359 (159) ml, respectively). The mean ( sd ) package size of IPS drinks was significantly different for all countries (range: Australia=370 (149) ml to New Zealand=484 (191) ml P 0·01). The mean ( sd ) package size of Dutch BPS drinks (1313 (323) ml) was significantly smaller compared with the other countries (New Zealand=1481 (595) ml, Australia=1542 (595) ml, Canada=1550 (434) ml P ·01). The mean ( sd ) serving size of BPS drinks was significantly different across all countries (range: Netherlands=216 (30) ml to Canada=248 (31) ml P 0·00). New Zealand had the largest package and serving sizes of the countries assessed. In all countries, a large number of different serving sizes were used to provide information on the amount appropriate to consume in one sitting. At this point there is substantial inconsistency in package sizes and manufacturer-recommended serving sizes of sweet beverages within and between four high-income countries, especially for IPS drinks. As consumers do factor serving size into their judgements of healthiness of a product, serving size regulations, preferably set by governments and global health organisations, would provide consistency and assist in iduals in making healthier food choices.
Publisher: Elsevier BV
Date: 03-2011
Publisher: AMPCo
Date: 06-2017
DOI: 10.5694/MJA16.00332
Abstract: To describe the management of cardiovascular disease (CVD) risk in Australian patients with diabetes to compare the effectiveness of a quality improvement initiative for people with and without diabetes. Subgroup analyses of patients with and without diabetes participating in a cluster randomised trial. Indigenous people (≥ 35 years old) and non-Indigenous people (≥ 45 years old) who had attended one of 60 Australian primary health care services at least three times during the preceding 24 months and at least once during the past 6 months. Quality improvement initiative comprising point-of-care electronic decision support with audit and feedback tools. Adherence to CVD risk screening and prescribing guidelines. Baseline rates of guideline-recommended screening were higher for 8829 patients with diabetes than for 44 335 without diabetes (62.0% v 39.5% P < 0.001). Baseline rates of guideline-recommended prescribing were greater for patients with diabetes than for other patients at high risk of CVD (55.5% v 39.6% P < 0.001). The proportions of patients with diabetes not attaining recommended treatment targets for blood pressure, low-density lipoprotein-cholesterol or HbA1c levels who were not prescribed the corresponding therapy at baseline were 28%, 44% and 24% respectively. The intervention was associated with improved screening rates, but the effect was smaller for patients with diabetes than for those without diabetes (rate ratio [RR], 1.14 v 1.28 P = 0.01). It was associated with improved guideline-recommended prescribing only for undertreated in iduals at high risk the effect size was similar for those with and without diabetes (RR, 1.63 v 1.53 P = 0.28). Adherence to CVD risk management guidelines was better for people with diabetes, but there is room for improvement. The intervention was modestly effective in people with diabetes, but further strategies are needed to close evidence-practice gaps.Australian and New Zealand Clinical Trials Registry number: ACTRN12611000478910.
Publisher: Elsevier BV
Date: 04-2021
Publisher: Oxford University Press (OUP)
Date: 21-11-2012
Publisher: Springer Science and Business Media LLC
Date: 14-01-2015
DOI: 10.1007/S13679-014-0134-7
Abstract: Rates of overweight and obesity have increased dramatically in all regions of the world over the last few decades. Almost all of the world's population now has ubiquitous access to low-cost, but highly-processed, energy-dense, nutrient-poor food products. These changes in the food supply, rather than decreases in physical activity, are most likely the primary driver of population weight gain and obesity. To-date, the majority of prevention efforts focus on personalised approaches targeting in iduals. Population-wide food supply interventions addressing sodium and trans fat reduction have proven highly effective and comparable efforts are now required to target obesity. The evidence suggests that strategies focusing upon reducing the energy density and portion size of foods will be more effective than those targeting specific macronutrients. Government leadership, clearly specified targets, accountability and transparency will be the key to achieving the food supply changes required to address the global obesity epidemic.
Publisher: Elsevier BV
Date: 09-2021
Publisher: Public Library of Science (PLoS)
Date: 20-11-2020
DOI: 10.1371/JOURNAL.PMED.1003427
Abstract: Front-of-pack nutrition labelling (FoPL) of packaged foods can promote healthier diets. Australia and New Zealand (NZ) adopted the voluntary Health Star Rating (HSR) scheme in 2014. We studied the impact of voluntary adoption of HSR on food reformulation relative to unlabelled foods and examined differential impacts for more-versus-less healthy foods. Annual nutrition information panel data were collected for nonseasonal packaged foods sold in major supermarkets in Auckland from 2013 to 2019 and in Sydney from 2014 to 2018. The analysis s le covered 58,905 unique products over 14 major food groups. We used a difference-in-differences design to estimate reformulation associated with HSR adoption. Healthier products adopted HSR more than unhealthy products: % of products that achieved 4 or more stars displayed the label compared to % of products that achieved 2 stars or less. Products that adopted HSR were 6.5% and 10.7% more likely to increase their rating by ≥0.5 stars in Australia and NZ, respectively. Labelled products showed a −4.0% [95% confidence interval (CI): −6.4% to −1.7%, p = 0.001] relative decline in sodium content in NZ, and there was a −1.4% [95% CI: −2.7% to −0.0%, p = 0.045] sodium change in Australia. HSR adoption was associated with a −2.3% [−3.7% to −0.9%, p = 0.001] change in sugar content in NZ and a statistically insignificant −1.1% [−2.3% to 0.1%, p = 0.061] difference in Australia. Initially unhealthy products showed larger reformulation effects when adopting HSR than healthier products. No evidence of a change in protein or saturated fat content was observed. A limitation of our study is that results are not sales weighted. Thus, it is not able to assess changes in overall nutrient consumption that occur because of HSR-caused reformulation. Also, participation into labelling and reformulation is jointly determined by producers in this observational study, impacting its generalisability to settings with mandatory labelling. In this study, we observed that reformulation changes following voluntary HSR labelling are small, but greater for initially unhealthy products. Initially unhealthy foods were, however, less likely to adopt HSR. Our results, therefore, suggest that mandatory labelling has the greatest potential for improving the healthiness of packaged foods.
Publisher: Wiley
Date: 02-2009
Publisher: JMIR Publications Inc.
Date: 25-01-2021
Abstract: egular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. he aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. ow-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords “salt substitute,” “low-sodium salt,” “potassium salt,” “mineral salt,” and “sodium reduced salt” in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. ow-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. R2-10.1111/jch.14054
Publisher: American Medical Association (AMA)
Date: 08-12-2021
Publisher: Elsevier BV
Date: 08-2013
DOI: 10.1016/J.AHJ.2013.05.007
Abstract: Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on macrovascular complications of diabetes remain to be determined. CANVAS is a double-blind, placebo-controlled trial designed to evaluate the effects of canagliflozin on the risk of cardiovascular disease and to assess safety and tolerability in patients with inadequately controlled T2DM and increased cardiovascular risk. The first of 2 planned phases randomized 4,330 in iduals to placebo, canagliflozin 100 or 300 mg (1:1:1) with planned follow-up of about 2 years to substantiate potential cardiovascular protection by assessing key biomarkers and to achieve initial safety objectives. By the end of mid-September 2012, a total of 7174 patient-years of follow-up were accrued. Mean baseline age was 62 years, duration of diabetes 13 years hemoglobin A1c 8.2%, fasting plasma glucose 9.3 mmol/L, and body mass index 32 kg/m(2). Of the participants, 34% are female and 57% had a history of atherosclerotic vascular disease. Participants will be followed up to achieve primary safety and tolerability objectives and to investigate secondary outcomes. The planned second phase will not be undertaken. CANVAS will define the effects of canagliflozin on biomarkers and provide data on cardiovascular safety against established regulatory parameters.
Publisher: Oxford University Press (OUP)
Date: 02-09-2005
Publisher: Public Library of Science (PLoS)
Date: 06-08-2018
Publisher: Elsevier BV
Date: 02-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 14-04-2009
DOI: 10.1161/CIRCULATIONAHA.108.819201
Abstract: Background— The rate of cardiovascular disease is widely considered to be increasing throughout India. Precise and reliable data on fatal and nonfatal cardiovascular disease, however, are few, and little is known about the use of preventive therapies. This is particularly true for rural regions. Methods and Results— Data were collected from 53 villages in the Godavari region of Andhra Pradesh. Mortality data were obtained from a verbal autopsy-based mortality surveillance system during a 12-month period in 2003 to 2004. The prevalence of nonfatal cardiovascular disease and the use of preventive therapies were estimated from a stratified random s le of 4535 adults (≥30 years of age) in 2005. Cardiovascular disease was the leading cause of mortality, accounting for at least 32% of all deaths. The average age at cardiovascular death was 65 years, and 51% of all cardiovascular deaths occurred in patients years of age. Among adults, the prevalence of coronary heart disease was estimated to be 4.8% (95% CI, 4.1 to 5.5), and the prevalence of cerebrovascular disease was estimated at 2.0% (95% CI, 1.5 to 2.4). Among in iduals with either diagnosis, 14% (95% CI, 10 to 18) reported taking aspirin, 41% (95% CI, 36 to 47) took a blood pressure-lowering medication, and 5% (95% CI, 3 to 7) reported using a cholesterol-lowering medication. Conclusion— This region has a large disease burden attributable to cardiovascular disease with significant underuse of proven, low-cost preventive medications.
Publisher: Wiley
Date: 23-08-2021
DOI: 10.1111/DOM.14525
Abstract: To determine the reasons for hospitalizations in the CANagliflozin cardioVascular Assessment Study (CANVAS) programme and the effects of the sodium‐glucose co‐transporter‐2 inhibitor canagliflozin on hospitalization. A secondary analysis was performed on the CANVAS programme that included 10 142 participants with type 2 diabetes randomized to canagliflozin or placebo. The primary outcome was the rate of total (first plus all recurrent) all‐cause hospitalizations (ACH). Secondary outcomes were total hospitalizations categorized by the Medical Dictionary for Regulatory Activities hierarchy at the system organ class level, reported by investigators at each centre. Outcomes were assessed using negative binomial models. Of the 7115 hospitalizations reported, the most common reasons were cardiac disorders (23.7%), infections and infestations (15.0%), and nervous system disorders (9.0%). The rate of total ACH was lower in the canagliflozin group (n = 5795) compared with the placebo group (n = 4347): 197.9 versus 215.8 participants per 1000 patient‐years, respectively (rate ratio [RR] 0.92 95% confidence interval [CI] 0.86, 0.98). Canagliflozin reduced the rate of total hospitalizations because of cardiac disorders (RR 0.81 95% CI 0.75, 0.88). There was no significant difference between the canagliflozin and placebo groups in the rates of total hospitalizations because of infections and infestations (RR 0.96 95% CI 0.86, 1.02) or nervous system disorders (RR 0.96 95% CI 0.88, 1.05). In the CANVAS programme, the most common reasons for hospitalization were cardiac disorders, infections and infestations, and nervous system disorders. Canagliflozin, compared with placebo, reduced the rate of total ACH.
Publisher: Hindawi Limited
Date: 12-2002
Abstract: Introduction Among in iduals with a history of myocardial infarction (MI), higher levels of blood pressure (BP) are associated with increased long-term risks of death from coronary heart disease. Treatment with a BPlowering regimen, based on omapatrilat may result in greater clinical benefits than treatment with a regimen based on a regular angiotensin-converting enzyme (ACE) inhibitor because of more favourable effects on the renin-angiotensin-aldosterone system. Methods Seven hundred and twenty-three clinically stable patients with a history of MI or unstable angina, and a mean entry BP of 134/77 mmHg, were randomised to six months treatment with omapatrilat 40 mg, omapatrilat 20 mg, or matching placebo. Results After six months, mean BP levels (systolic/diastolic) in the omapatrilat 40 mg group were reduced by 4.3/ 2.9 mmHg (95% confidence interval 1.3 to 7.2/1.2 to 4.6). Mean BP levels in the omapatrilat 20 mg group were reduced by 4.6/1.0 mmHg (1.6 to 7.6/—0.7 to 2.6) in comparison with the placebo group. Both doses of omapatrilat also produced significant decreases in plasma ACE activity and significant increases in levels of plasma renin activity, atrial natriuretic peptide, endothelin and homocysteine (p .05 for all). Premature discontinuations were more frequent with omapatrilat than with placebo (p .001 for 20 mg and 40 mg). Conclusions Omapatrilat produced changes in BP, neurohormone and biochemical parameters that were similar for the two doses. The long-term clinical implications of the observed effects are uncertain and a large-scale randomised trial would be required to reliably establish the effects of omapatrilat on the risks of major vascular disease events among patients with coronary heart disease.
Publisher: Springer Science and Business Media LLC
Date: 05-03-2021
DOI: 10.1038/S41371-021-00510-X
Abstract: Sodium and potassium appear to interact with each other in their effects on blood pressure with potassium supplementation having a greater blood pressure lowering-effect when sodium intake is high. Whether the effect of sodium reduction on blood pressure varies according to potassium intake levels is unclear. We carried out a systematic review and meta-analysis to examine the impact of baseline potassium intake on blood pressure response to sodium reduction in randomized trials in adult populations, with sodium and potassium intake estimated from 24-h urine s les. We included 68 studies involving 5708 participants and conducted univariable and multivariable meta-regression. The median intake of baseline potassium was 67.7 mmol (Interquartile range: 54.6-76.4 mmol), and the mean reduction in sodium intake was 128 mmol (95% CI: 107-148). Multivariable meta-regression that included baseline 24-h urinary potassium excretion, age, ethnicity, baseline blood pressure, change in 24-h urinary sodium excretion, as well as the interaction between baseline 24-h urinary potassium excretion and change in 24-h urinary sodium excretion did not identify a significant association of baseline potassium intake levels with the blood pressure reduction achieved with a 50 mmol lowering of sodium intake (p > 0.05 for both systolic and diastolic blood pressure). A higher starting level of blood pressure was consistently associated with a greater blood pressure reduction from reduced sodium consumption. However, the nonsignificant findings may subject to the limitations of the data available. Additional studies with more varied potassium intake levels would allow a more confident exclusion of an interaction.
Publisher: AMPCo
Date: 12-2011
DOI: 10.5694/MJA11.11304
Publisher: American Diabetes Association
Date: 10-04-2014
DOI: 10.2337/DC13-2727
Abstract: Moderate alcohol consumption has been associated with a reduced risk of mortality and coronary artery disease. The relationship between cardiovascular health and alcohol use in type 2 diabetes is less clear. The current study assesses the effects of alcohol use among participants in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial. The effects of alcohol use were explored using Cox regression models, adjusted for potential confounders. The study end points were cardiovascular events (cardiovascular death, myocardial infarction, and stroke), microvascular complications (new or worsening nephropathy or retinopathy), and all-cause mortality. During a median of 5 years of follow-up, 1,031 (9%) patients died, 1,147 (10%) experienced a cardiovascular event, and 1,136 (10%) experienced a microvascular complication. Compared with patients who reported no alcohol consumption, those who reported moderate consumption had fewer cardiovascular events (adjusted hazard ratio [aHR] 0.83 95% CI 0.72–0.95 P = 0.008), less microvascular complications (aHR 0.85 95% CI 0.73–0.99 P = 0.03), and lower all-cause mortality (aHR 0.87 96% CI 0.75–1.00 P = 0.05). The benefits were particularly evident in participants who drank predominantly wine (cardiovascular events aHR 0.78, 95% CI 0.63–0.95, P = 0.01 all-cause mortality aHR 0.77, 95% CI 0.62–0.95, P = 0.02). Compared with patients who reported no alcohol consumption, those who reported heavy consumption had dose-dependent higher risks of cardiovascular events and all-cause mortality. In patients with type 2 diabetes, moderate alcohol use, particularly wine consumption, is associated with reduced risks of cardiovascular events and all-cause mortality.
Publisher: Wiley
Date: 29-12-2015
DOI: 10.1111/JCH.12762
Publisher: BMJ
Date: 06-2023
DOI: 10.1136/BMJDRC-2022-003270
Abstract: Relationships between glycemic-lowering effects of sodium glucose co-transporter 2 inhibitors and impact on kidney and cardiovascular outcomes are uncertain. We analyzed 4395 in iduals with prebaseline and postbaseline hemoglobin A1c (HbA1c) randomized to canagliflozin (n=2193) or placebo (n=2202) in The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation trial. Effects on HbA1c were assessed using mixed models. Mediation of treatment effects by achieved glycemic control was analyzed using proportional hazards regression with and without adjustment for achieved HbA1c. End points included combined kidney or cardiovascular death, end-stage kidney disease or doubling of serum creatinine (primary trial outcome), and in idual end point components. HbA1c lowering was modified by baseline estimated glomerular filtration rate (eGFR). For baseline eGFR 60–90, 45–59, and 30–44 mL/min/1.73 m 2 , overall HbA1c (canagliflozin vs placebo) decreased by −0.24%, −0.14%, and −0.08% respectively and likelihood of .5% decrease in HbA1c decreased with ORs of 1.47 (95% CI 1.27 to 1.67), 1.12 (0.94 to 1.33) and 0.99 (0.83 to 1.18), respectively. Adjustment for postbaseline HbA1c marginally attenuated canagliflozin effects on primary and kidney composite outcomes: unadjusted HR 0.67 (95% CI 0.57 to 0.80) and 0.66 (95% CI 0.53 to 0.81) adjusted for week 13 HbA1c, HR 0.71 (95% CI 0.060 to 0.84) and 0.68 (95% CI 0.55 to 0.83). Results adjusted for time-varying HbA1c or HbA1c as a cubic spline were similar and consistent with preserved clinical benefits across a range of excellent and poor glycemic control. The glycemic effects of canagliflozin are attenuated at lower eGFR but effects on kidney and cardiac end points are preserved. Non-glycemic effects may be primarily responsible for the kidney and cardioprotective benefits of canagliflozin.22
Publisher: Elsevier BV
Date: 02-2012
DOI: 10.1038/KI.2012.383
Abstract: Albuminuria and a reduced glomerular filtration rate are conventional predictors of a future decline in kidney function in patients with type 2 diabetes mellitus. Using a nested case-control study we assessed whether circulating transforming growth factor-β1 (TGF-β1) and bone morphogenetic protein-7 (BMP-7) levels more accurately predict renal end points than the conventional markers. Cases were defined as those who developed a renal end point (doubling of serum creatinine to at least 200 μmol/l, the need for renal replacement therapy, or death due to renal disease) during the study. Using propensity scoring, two controls were selected for each of 281 cases. Participants who developed renal end points had significantly higher total TGF-β1, lower BMP-7 levels, and a higher total TGF-β1 to BMP-7 ratio at baseline. A graded increase in risk was found in in iduals with lower BMP-7 levels (odds ratio 24.07, for the lowest to the highest tertile), or significantly higher TGF-β1 levels (odds ratio for the highest to the lowest tertile, 8.43). The area under the receiver operating characteristic curve (c-statistic) for the conventional predictors was 0.73. Using BMP-7 and total and active TGF-β1, the c-statistic was 0.94 (significantly higher to conventional predictors). Thus, our results suggest these novel kidney markers are better predictors of renal progression than the conventional predictors in patients with type 2 diabetes mellitus.
Publisher: Elsevier BV
Date: 09-2009
DOI: 10.1016/J.AHJ.2009.05.034
Abstract: Developing countries are experiencing increasing levels of cardiovascular disease (CVD). Although there is a good understanding of how to deliver CVD prevention programs in developed countries, there are few data regarding strategies for CVD prevention in resource-poor settings. This study aimed to implement and evaluate a CVD prevention program in a rural area of India. The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion c aign. A factorial, cluster-randomized trial design will be used to evaluate these, in which villages will be exposed to one, both, or neither of the interventions for a period of about 12 months. Surveys of households in every village will be used to assess outcomes in all high-risk in iduals and a s le of the general adult population. The primary outcome of the algorithm-based component of this study will be the percentage of high-risk in iduals that have been "identified"-defined as having received a cardiovascular-risk assessment in the last 12 months. The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk (green-leafy vegetables, fruits, oily foods, salt, smoking, physical activity). Secondary outcomes include a range of measures defining uptake of different preventive strategies. This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically designed for delivery in a resource-poor area in India.
Publisher: Wiley
Date: 08-12-2015
DOI: 10.1111/DOM.12589
Abstract: To assess the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes enrolled in the CANagliflozin cardioVascular Assessment Study (CANVAS) who were on an incretin mimetic [dipeptidyl peptidase-4 (DPP-4) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist]. CANVAS is a double-blind, placebo-controlled study that randomized participants to canagliflozin 100 or 300 mg or placebo added to routine therapy. The present post hoc analysis assessed the efficacy and safety of canagliflozin 100 and 300 mg compared with placebo in subsets of patients from CANVAS who were taking background DPP-4 inhibitors or GLP-1 receptor agonists with or without other antihyperglycaemic agents at week 18. Of the 4330 patients in CANVAS, 316 were taking DPP-4 inhibitors and 95 were taking GLP-1 receptor agonists. At 18 weeks, canagliflozin 100 and 300 mg provided larger placebo-subtracted reductions in glycated haemoglobin (HbA1c) in patients taking DPP-4 inhibitors [-0.56% (95% confidence interval [CI]: -0.77, -0.35), and -0.75% (95% CI: -0.95, -0.54), respectively] and GLP-1 receptor agonists [-1.00% (95% CI: -1.35, -0.65), and -1.06% (95% CI: -1.43, -0.69), respectively]. Body weight and blood pressure (BP) reductions were seen with canagliflozin versus placebo in both subsets. Higher incidences of genital mycotic infections and osmotic diuresis-related adverse events (AEs) were seen with canagliflozin compared with placebo. The incidence of hypoglycaemia was numerically higher with canagliflozin versus placebo nearly all events occurred in patients on background insulin or insulin secretagogues. In patients on background incretin mimetics, canagliflozin improved HbA1c, body weight and BP, with an increased incidence of AEs related to SGLT2 inhibition.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2003
Publisher: Wiley
Date: 05-07-2010
DOI: 10.1111/J.1464-5491.2010.03080.X
Abstract: We investigated the association between alcohol consumption and diabetic retinopathy and deterioration of visual acuity in in iduals with Type 2 diabetes. We conducted a cohort analysis of 1239 participants with Type 2 diabetes aged 55-81 years enrolled in the AdRem study, a sub-study of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial. Current and past consumption of wine, spirits and beer was measured by self-report. Moderate and heavy alcohol consumption was defined as 1-14 and >14 drinks/week, respectively. Diabetic retinopathy, measured by mydriatic stereoscopic seven-field retinal photography, was defined by a 2-step progression in the Early Treatment of Diabetic Retinopathy Study (ETDRS) score or the presence of any retinal vascular lesions. Deterioration of visual acuity was defined by a decrease of two lines in best vision in either eye, measured corrected, or through a pinhole using a Snellen chart. In a mean follow-up of 5.5 years, we identified 182 participants with a 2-step progression in the ETDRS score, 640 participants with the presence of any retinal vascular lesions and 693 participants with a deterioration of visual acuity. Current moderate consumption of alcohol, compared with no current consumption, was not associated with presence or progression of diabetic retinopathy however, it was associated with higher risk of deterioration of visual acuity (multivariable-adjusted OR 1.83 95% CI 1.34-2.48 P<0.001). Alcohol consumption is associated with increased risk of deterioration of visual acuity, but not with retinopathy in in iduals with Type 2 diabetes.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 28-05-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2019
Publisher: Oxford University Press (OUP)
Date: 10-2019
DOI: 10.1093/EURHEARTJ/EHZ748.0446
Abstract: Authoritative medical and public health agencies in most countries advise to reduce population dietary salt intake to under 5–6 g/day as a strategy for preventing high blood pressure and cardiovascular disease. However, there is still dispute about whether salt reduction should be adopted by all populations. In addition, the effect of duration of dietary salt reduction has not been sufficiently investigated. To understand the effect of dietary salt reduction on blood pressure and the impact of intervention duration. A systematic review and meta-analysis was conducted. Randomized controlled trials that allocated participants to low and high salt intake, without confounding from unequal concomitant interventions, were included. We excluded studies done in in iduals younger than 18 years, pregnant women, in iduals with renal disease or heart failure, and studies with sodium excretion estimated from spot urine. Random effect meta-analysis was used to generate pooled estimates of the effect on 24-hour urinary sodium excretion, systolic and diastolic blood pressure. Multivariate meta-regression was used to quantify the dose response effect of dietary salt on blood pressure change and to understand the impact of the intervention duration. 125 studies were included with 162 data points extracted. Ninety-nine data points (61%) had interventions under 4 weeks. Overall, 24-hour urinary sodium excretion changed by −141 mmol (95% CI: −156 −126), systolic blood pressure changed by −4.4 mm Hg (95% CI: −5.2 −3.7) and diastolic blood pressure changed by −2.4 mm Hg (95% CI: −2.9 −1.9). Sodium reduction resulted in a significant decrease of systolic blood pressure in all subgroups except in participants with low baseline sodium intake ( mmol) (Figure 1). Each 100 mmol reduction of sodium was associated with 2.7 mm Hg (95% CI: 1.0 4.4 p=0.002) reduction of systolic blood pressure and 1.2 mm Hg (95% CI: 0.0 2.4 p=0.046) reduction of diastolic blood pressure after adjusting for intervention duration, age, sex, race, baseline blood pressure, baseline sodium intake and interaction between age and baseline blood pressure. For the same amount of salt reduction, a 10 mm Hg higher baseline systolic blood pressure would result in 2.5 mm Hg greater reduction of systolic blood pressure. There is not enough evidence to show the impact of intervention duration. Figure 1 Our meta-analysis showed that sodium reduction could reduce blood pressure in all adult populations regardless of age, sex and race. The effect of salt reduction on systolic blood pressure increases with higher baseline blood pressure. Further studies, designed to investigate the impact of intervention duration, are needed to understand the significance of the duration. None
Publisher: BMJ
Date: 20-07-2011
Abstract: To determine levels of cardiovascular disease (CVD) prevention and to model the potential impact of improved prevention strategies for a large rural Indian region. A cross-sectional study with modelling of coronary heart disease (CHD) events over 10 years. Rural Andhra Pradesh, India. A stratified random s le of 1,079 adults 30 years and older. Proportion on medical and behavioural treatments for prevention of CVD estimated number of CHD events using a locally recalibrated Framingham risk equation. Among the 3.5% (95% CI 2.1% to 4.9%) with existing CVD, 49.3% (95% CI 28.8% to 69.8%) were on blood pressure (BP)-lowering medication, 4.7% (95% CI 0 to 10.4%) were on cholesterol-lowering medication, 24.6% (95% CI 9% to 40.3%) had increased exercise and 26.9% (95% CI 2.6% to 51.1%) attempted to quit smoking. Among the 7.6% (95% CI 6.2% to 8.9%) with a high global CHD risk (>20% over 10 years), 29.5% (95% CI 19.5 to 39.5%) were on BP-lowering medication, 2.8% (95% CI 0 to 6.7%) were on cholesterol-lowering medication, 19.4% (95% CI 10.9% to 28%) had increased exercise and 24.8% (95% CI 15.8% to 33.8%) attempted to quit smoking. If confirmed drug therapies were provided to all in iduals at high risk there would be a 28% reduction in cardiovascular events over 10 years at an approximate annual treatment cost of US$533 per event avoided. There are serious deficiencies in CVD prevention in rural areas of India. Addressing these with simple confirmed drug treatments could produce a large reduction in the future cardiovascular burden in India.
Publisher: Informa UK Limited
Date: 1997
DOI: 10.3109/10641969709083190
Abstract: Cerebrovascular disease and high blood pressure both appear to increase the risk of vascular dementia. PROGRESS aims to investigate whether blood pressure lowering with an angiotensin coverting enzyme inhibitor-based regimen will reduce the risk of cognitive impairment in patients with a history of stroke or transient ischaemic attack. A total of at least 6000 patients will be randomised to receive perindopril (+/- indapamide) or matching placebo(s), with treatment and follow-up scheduled to continue for at least 4 years. Substudies will investigate the effects of treatment on cognitive decline in subgroups defined by apo-E genotype and on white matter lesions assessed by magnetic resonance imaging. Final results from the study should be available in 2001.
Publisher: American Association for Cancer Research (AACR)
Date: 04-2014
DOI: 10.1158/1055-9965.EPI-13-1209
Abstract: Cancer prevention postdoctoral fellowships have existed since the 1970s. The National Cancer Institute facilitated a meeting by a panel of experts in April 2013 to consider four important topics for future directions for cancer prevention postdoctoral training programs: (i) future research needs (ii) underrepresented disciplines (iii) curriculum and (iv) career preparation. Panelists proffered several areas needing more research or emphasis, ranging from computational science to culture. Health care providers, along with persons from nontraditional disciplines in scientific training programs such as engineers and lawyers, were among those recognized as being underrepresented in training programs. Curriculum suggestions were that fellows receive training in topics such as leadership and human relations, in addition to learning the principles of epidemiology, cancer biologic mechanisms, and behavioral science. For career preparation, there was a clear recognition of the ersity of employment options available besides academic positions, and that program leaders should do more to help fellows identify and prepare for different career paths. The major topics and strategies covered at this meeting can help form the basis for cancer prevention training program leaders to consider modifications or new directions, and keep them updated with the changing scientific and employment climate for doctoral degree recipients and postdoctoral fellows. Cancer Epidemiol Biomarkers Prev 23(4) 679–83. ©2014 AACR.
Publisher: Springer Science and Business Media LLC
Date: 17-02-2010
DOI: 10.1007/S00125-010-1681-4
Abstract: Available multivariable equations for cardiovascular risk assessment in people with diabetes have been derived either from the general population or from populations with diabetes. Their utility and comparative performance in a contemporary group of patients with type 2 diabetes are not well established. The aim of this study was to evaluate the performance of the Framingham and UK Prospective Diabetes Study (UKPDS) risk equations in participants who took part in the Action in Diabetes and Vascular disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE) trial. The 4-year risks of cardiovascular disease (CVD) and its constituents were estimated using two published Framingham and the UKPDS risk equations in 7,502 in iduals with type 2 diabetes without prior known CVD at their enrolment in the trial. The risk of major CVD was overestimated by 170% (95% CI 146-195%) and 202% (176-231%) using the two Framingham equations. The risk of major coronary heart disease was overestimated by 198% (162-238%) with the UKPDS, and by 146% (117-179%) and 289% (243-341%) with the two different Framingham equations, respectively. The risks of stroke events were also overestimated with the UKPDS and one of the Framingham equations. The ability of these equations to rank risk among ADVANCE participants was modest, with c-statistics ranging from 0.57 to 0.71. Results stratified by sex, treatment allocation and ethnicity were broadly similar. Application of the Framingham and UKPDS risk equations to a contemporary treated group of patients with established type 2 diabetes is likely to substantially overestimate cardiovascular risk.
Publisher: Massachusetts Medical Society
Date: 27-12-2012
DOI: 10.1056/NEJME1212368
Publisher: Oxford University Press (OUP)
Date: 16-12-2022
Publisher: Wiley
Date: 22-07-2019
DOI: 10.1111/OBR.12879
Abstract: We compared the healthiness of packaged foods and beverages between selected countries using the Health Star Rating (HSR) nutrient profiling system. Packaged food and beverage data collected 2013-2018 were obtained for Australia, Canada, Chile, China, India, Hong Kong, Mexico, New Zealand, Slovenia, South Africa, the UK, and USA. Each product was assigned to a food or beverage category and mean HSR was calculated overall by category and by country. Median energy density (kJ/100 g), saturated fat (g/100 g), total sugars (g/100 g) and sodium (mg/100 g) contents were calculated. Countries were ranked by mean HSR and median nutrient levels. Mean HSR for all products (n = 394,815) was 2.73 (SD 1.38) out of 5.0 (healthiest profile). The UK, USA, Australia and Canada ranked highest for overall nutrient profile (HSR 2.74-2.83) and India, Hong Kong, China and Chile ranked lowest (HSR 2.27-2.44). Countries with higher overall HSR generally ranked better with respect to nutrient levels. India ranked consistently in the least healthy third for all measures. There is considerable variability in the healthiness of packaged foods and beverages in different countries. The finding that packaged foods and beverages are less healthy in middle-income countries such as China and India suggests that nutrient profiling is an important tool to enable policymakers and industry actors to reformulate products available in the marketplace to reduce the risk of obesity and NCDs among populations.
Publisher: Elsevier BV
Date: 02-2022
DOI: 10.1053/J.AJKD.2021.05.005
Abstract: Canagliflozin reduced the risk of kidney failure and related outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. This analysis of CREDENCE trial data examines the effect of canagliflozin on the incidence of kidney-related adverse events (AEs). A randomized, double-blind, placebo-controlled, multicenter international trial. 4,401 trial participants with T2DM, CKD, and urinary albumin-creatinine ratio >300-5,000 mg/g. Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo. Rates of kidney-related AEs were analyzed using an on-treatment approach, overall and by screening estimated glomerular filtration rate (eGFR) strata (30-<45, 45-<60, and 60-<90 mL/min/1.73 m Canagliflozin was associated with a reduction in the overall incidence rate of kidney-related AEs (60.2 vs 84.0 per 1,000 patient-years hazard ratio [HR], 0.71 [95% CI, 0.61-0.82] P < 0.001), with consistent results for serious kidney-related AEs (HR, 0.72 [95% CI, 0.51-1.00] P = 0.05) and acute kidney injury (AKI HR, 0.85 [95% CI, 0.64-1.13] P = 0.3). The rates of kidney-related AEs were lower with canagliflozin relative to placebo across the 3 eGFR strata (HRs of 0.73, 0.60, and 0.81 for eGFR 30-<45, 45-<60, and 60-<90 mL/min/1.73 m Kidney-related AEs including AKI were investigator-reported and collected without central adjudication. Biomarkers of AKI and structural tubular damage were not measured, and creatinine data after an AKI event were not available for all participants. Compared with placebo, canagliflozin was associated with a reduced incidence of serious and nonserious kidney-related AEs in patients with T2DM and CKD. These results highlight the safety of canagliflozin with regard to adverse kidney-related AEs. The CREDENCE trial and this analysis were funded by Janssen Research & Development, LLC, and were conducted as a collaboration between the funder, an academic steering committee, and an academic research organization, George Clinical. The CREDENCE trial was registered at ClinicalTrials.gov with identifier number NCT02065791.
Publisher: Wiley
Date: 28-06-2022
DOI: 10.1111/DOM.14779
Abstract: To test the hypothesis that the reduction in urinary kidney injury molecule‐1 (KIM‐1) observed with the sodium‐glucose cotransporter‐2 (SGLT2) inhibitor canagliflozin is mediated through its effects on urine albumin to creatinine ratio (UACR) and monocyte chemoattractant protein‐1 (MCP‐1) by assessing the proportion of the effect of canagliflozin on KIM‐1 that is mediated through its effects on MCP‐1 and UACR in patients with type 2 diabetes and albuminuric kidney disease. We measured KIM‐1 and MCP‐1 levels in urine s les from the CANVAS trial at baseline and Week 52 with the Mesoscale QuickPlex SQ 120 platform. KIM‐1 and MCP‐1 were standardized by urinary creatinine (Cr). The proportion of the effect of canagliflozin that is mediated through UACR and MCP‐1/Cr on KIM‐1/Cr was estimated with G‐computation. In total, 763 patients with micro‐ or macroalbuminuria (17.6% of the total cohort) were included. Baseline characteristics were well balanced between the canagliflozin and placebo group. At Year 1, canagliflozin compared to placebo reduced UACR, MCP‐1/Cr and KIM‐1/Cr by 40.4% (95% CI 31.0, 48.4), 18.1% (95% CI 8.9, 26.4) and 30.9% (95% CI 23.0, 38.0), respectively. The proportion of the effect of canagliflozin on KIM‐1/Cr mediated by its effect on UACR and in turn on MCP‐1/Cr was 15.2% (95% CI 9.4, 24.5). Canagliflozin reduces urinary KIM‐1, suggesting decreased tubular damage. This effect was partly mediated through a reduction in MCP‐1, indicative of reduced tubular inflammation, which was in turn mediated by a reduction in UACR. This post hoc analysis suggests that urinary albumin leakage may lead to tubular inflammation and induction of injury, and provide mechanistic insight for how canagliflozin may ameliorate tubular damage, but further research is required to confirm these findings.
Publisher: Springer Science and Business Media LLC
Date: 28-11-2022
DOI: 10.1186/S12933-022-01666-7
Abstract: Enhanced de-novo collagen type VI (COL VI) formation has been associated with kidney and cardiovascular fibrosis. We hypothesized that endotrophin (ETP), a product specifically generated during collagen type VI formation, may be prognostic for heart failure (HF), cardiovascular death (CVD), kidney endpoints, and all-cause mortality in patients with type 2 diabetes. We measured ETP in plasma (P-ETP) and urine (U-ETP) s les collected at baseline and follow-up (year 3) from the randomized controlled trial, CANagliflozin cardioVascular Assessment Study (CANVAS), by use of the PRO-C6 ELISA measuring COL VI formation and ETP. At baseline, plasma and urine s les were available for 3531 and 3423 patients, respectively. At year 3, plasma and urine s les were available for 2178 (61.7%) and 2070 (60.5%) patients, respectively Patients were followed for a median of 6.1 years, and endpoints included: incident HF, CVD, three kidney composite endpoints, and all-cause mortality. Backward selection was used to identify variables to be included in the analyses. Robustness of the association with outcome was assessed by bootstrap analyses. In univariable analysis, P-ETP predicted all investigated outcomes (all p 0.0001), remained independently associated with all outcomes after adjustment for conventional risk factors (all p 0.004), and increased C-statistics of the models for the outcomes HF, CVD, HFCVD, all-cause mortality, and kidney composite 2 (ΔC ≥ 0.002). In bootstrap analysis, P-ETP was retained with a frequency ranging from 41.0 to 98.4% for all outcomes. Levels of U-ETP were associated with outcomes in univariable analysis, but associations with most outcomes were lost after adjustment for conventional risk factors. The increase in P-ETP over time was greater with increasing albuminuria stage (p 0.0001) and was independently associated with the kidney endpoints (p 0.03). In the placebo arm, the increase in P-ETP was prognostic for all-cause mortality (HR [95% CI] 1.14 [1.05–1.23], p = 0.003). Whereas levels of P-ETP were not impacted by treatment, levels of U-ETP significantly increased with canagliflozin treatment. P-ETP generated during COL VI formation predicts cardiovascular, kidney and mortality outcomes in patients with type 2 diabetes. As ETP identifies patients at increased risk of experiencing relevant outcomes, it may be used for patient enrichment in future clinical trials. Trial Registry Number (ClinicalTrials.gov Identifier): NCT01032629
Publisher: American College of Physicians
Date: 03-02-2015
DOI: 10.7326/M14-0773
Publisher: Oxford University Press (OUP)
Date: 13-12-2020
Abstract: Reducing population intakes of sugar has become a focus of many national and international public health policies. Packaged foods and beverages are key contributors to sugar intakes, and food labels can be an effective tool to reduce sugar consumption. The aim of this systematic review was to examine the influence of sugar label formats on 2 outcomes: consumers’ understanding of sugar information, and the amount of sugar in consumers’ food choices. Scopus, Web of Science, PubMed, CAB Abstracts, SciELO, and the Cochrane Library databases were searched up until February 4, 2020. Randomized experiments or quasi-experiments were included if they investigated the influence of sugar label formats on consumers’ understanding of sugar information or on the amount of sugar in consumers’ food choices. Data were extracted independently by 2 authors. Mean differences (MDs), standardized mean differences (SMDs), and odds ratios (ORs) plus 95%CIs were used to describe between-group differences for intervention label formats using random-effects models. Twenty-three studies, which examined 39 comparisons, were included. Label formats using “high in sugar” interpretative texts (traffic light labels [MD 41.6 95%CI 37.9–45.4] and warning signs [OR 1.33 95%CI 1.0–1.78]) were most effective in increasing consumers’ understanding of the sugar content in packaged foods. Health warning messages (SMD −0.32 95%CI −0.43 to −0.22), graphical depictions of sugar content in teaspoons (SMD −0.32 95%CI −0.48 to −0.17), and warning signs (SMD −0.24 95%CI −0.35 to −0.13) were most effective for influencing consumers to choose products with lower sugar content. Formats that provide an interpretation of sugar information, particularly those indicating if a product is high in sugar, were more helpful than only numerical information for improving consumer understanding and promoting food choices with less sugar. PROSPERO registration number CRD42018081222.
Publisher: Wiley
Date: 09-06-2022
DOI: 10.1111/DOM.14772
Abstract: To assess the effects of canagliflozin on the incidence of atrial fibrillation/atrial flutter (AF/AFL) and other key cardiorenal outcomes in a pooled analysis of the CANVAS and CREDENCE trials. Participants with type 2 diabetes and high risk of cardiovascular disease or chronic kidney disease were included and randomly assigned to canagliflozin or placebo. We explored the effects of canagliflozin on the incidence of first AF/AFL events and AF/AFL‐related complications (ischaemic stroke/transient ischaemic attack/hospitalization for heart failure). Major adverse cardiovascular events and a renal‐specific outcome by baseline AF/AFL status were analysed using Cox regression models. Overall, 354 participants experienced a first AF/AFL event. Canagliflozin had no detectable effect on AF/AFL (hazard ratio [HR] 0.82, 95% confidence interval [CI] 0.67‐1.02) compared with placebo. Subgroup analysis, however, suggested a possible reduction in AF/AFL in those with no AF/AFL history (HR 0.78, 95% CI 0.62‐0.99). Canagliflozin was also associated with a reduction in AF/AFL‐related complications (HR 0.74, 95% CI 0.65‐0.86). There was no evidence of treatment heterogeneity by baseline AF/AFL history for other key cardiorenal outcomes (all P interaction 0.14). Meta‐analysis of five sodium‐glucose cotransporter‐2 (SGLT2) inhibitor trials demonstrated a 19% reduction in AF/AFL events with active treatment (HR 0.81, 95% CI 0.72‐0.92). Overall, a significant effect of canagliflozin on the incidence of AF/AFL events could not be shown, however, a possible reduction in AF/AFL events in those with no prior history requires further investigation. Meta‐analysis suggests SGLT2 inhibition reduces AF/AFL incidence.
Publisher: Elsevier BV
Date: 04-2021
Publisher: Wiley
Date: 03-02-2016
DOI: 10.1111/JCH.12778
Publisher: Wiley
Date: 16-12-2013
DOI: 10.1111/DOM.12238
Abstract: The aim of this study was to assess associations between patient characteristics, intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type 2 diabetes. 11 140 patients from the Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation (ADVANCE) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of 5 years were categorized into two groups: effective glycaemic control [haemoglobin A1c (HbA1c) ≤ 7.0% or a proportionate reduction in HbA1c over 10%] or ineffective glycaemic control (HbA1c > 7.0% and a proportionate reduction in HbA1c less than or equal to 10%). Therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin. Pooled logistic regression models examined the associations between patient factors, intensification and effective glycaemic control. A total of 7768 patients (69.7%), including 3198 in the standard treatment group achieved effective glycaemic control. Compared to patients with ineffective control, patients with effective glycaemic control had shorter duration of diabetes and lower HbA1c at baseline and at the time of treatment intensification. Treatment intensification with addition of an oral agent or commencement of insulin was associated with a 107% [odds ratio, OR: 2.07 (95% confidence interval, CI: 1.95-2.20)] and 152% [OR: 2.52 (95% CI: 2.30-2.77)] greater chance of achieving effective glycaemic control, respectively. These associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification. Effective glycaemic control was associated with treatment intensification at lower HbA1c levels at all stages of the disease course and in both arms of the ADVANCE trial.
Publisher: Oxford University Press (OUP)
Date: 06-2007
Publisher: Massachusetts Medical Society
Date: 30-08-2007
DOI: 10.1056/NEJMOA067514
Publisher: Wiley
Date: 06-2003
DOI: 10.1046/J.1445-2197.2003.02647.X
Abstract: Heterotopic bone formation (HBF) is well established as a frequent complication of major hip surgery, but its importance as a cause of impaired postoperative outcome is uncertain. A systematic overview of all studies that reported the association of HBF with the risk of impaired range of movement, pain or poor function, late after hip arthroplasty. A computer-based search identified 37 relevant studies that included 10,826 in iduals. There were 30 studies (8305 participants) that assessed the association between HBF and range of movement, 14 studies (7420 participants) that assessed the association between HBF and pain and 16 studies (5918 participants) that assessed the association between HBF and function. Overall, there was a clear positive association of HBF with the risk of an impaired range of movement at the hip joint and with the risk of a poor functional outcome. The association of HBF with pain was unclear. There was evidence of effects of mild-to-moderate HBF on the postoperative range of movement. These results suggest that mild-to-moderate HBF, not just severe HBF, can influence outcome after major hip surgery. HBF may therefore be a more frequent cause of postoperative symptomatology than is generally believed. It is possible that effective prophylactic regimens will improve outcomes in large numbers of patients.
Publisher: Springer Science and Business Media LLC
Date: 31-03-2011
DOI: 10.1038/JHH.2011.25
Abstract: High dietary salt is a major contributor to increased blood pressure, the leading risk for death worldwide. In several countries, national programmes to reduce dietary salt have been implemented with leadership and involvement of hypertension experts. Other hypertension experts may be interested in assisting or leading a national programme to reduce dietary salt, however, may not have the experience or training to do so. The article is based on the experiences of three hypertension experts who have led the development of national dietary salt reduction programmes in the United Kingdom, Australia and Canada. The article advises developing leadership and a coalition, conducting a nation-specific environmental scan of facilitators and barriers, estimating the national health and financial costs of high dietary salt and the benefits of reducing salt intake, obtaining core documents to provide the scientific rational for the programme, developing a policy statement to outline the required actions to be undertaken, engaging government and industry, using media to gain public support, overcoming industry supported opposition and sustaining the effort long term. Resources and potential sources for international collaboration are provided as well as caveats for developing the programme within the specific nations' context and overall effort to improve health. Developing and leading a national salt reduction programme is a major commitment, however, reducing dietary salt is estimated to be one of the most effective strategies to improve a nation's health.
Publisher: Elsevier BV
Date: 11-2022
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2006
DOI: 10.1161/01.STR.0000221212.36860.C9
Abstract: Background and Purpose— The relationship between baseline and recurrent vascular events may be important in the targeting of secondary prevention strategies. We examined the relationship between initial event and various types of further vascular outcomes and associated effects of blood pressure (BP)–lowering. Methods— Subsidiary analyses of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) trial, a randomized, placebo-controlled trial that established the benefits of BP–lowering in 6105 patients (mean age 64 years, 30% female) with cerebrovascular disease, randomly assigned to either active treatment (perindopril for all, plus indapamide in those with neither an indication for, nor a contraindication to, a diuretic) or placebo(s). Results— Stroke subtypes and coronary events were associated with 1.5- to 6.6-fold greater risk of recurrence of the same event (hazard ratios, 1.51 to 6.64 P =0.1 for large artery infarction, P .0001 for other events). However, 46% to 92% of further vascular outcomes were not of the same type. Active treatment produced comparable reductions in the risk of vascular outcomes among patients with a broad range of vascular events at entry (relative risk reduction, 25% P .0001 for ischemic stroke 42%, P =0.0006 for hemorrhagic stroke 17%, P =0.3 for coronary events P homogeneity=0.4). Conclusions— Patients with previous vascular events are at high risk of recurrences of the same event. However, because they are also at risk of other vascular outcomes, a broad range of secondary prevention strategies is necessary for their treatment. BP–lowering is likely to be one of the most effective and generalizable strategies across a variety of major vascular events including stroke and myocardial infarction.
Publisher: Elsevier BV
Date: 04-2004
Publisher: Springer Science and Business Media LLC
Date: 27-07-2012
Abstract: Chronic diseases are the leading cause of premature death and disability in the world with over-nutrition a primary cause of diet-related ill health. Excess quantities of energy, saturated fat, sugar and salt derived from fast foods contribute importantly to this disease burden. Our objective is to collate and compare nutrient composition data for fast foods as a means of supporting improvements in product formulation. Surveys of fast foods will be done in each participating country each year. Information on the nutrient composition for each product will be sought either through direct chemical analysis, from fast food companies, in-store materials or from company websites. Foods will be categorized into major groups for the primary analyses which will compare mean levels of saturated fat, sugar, sodium, energy and serving size at baseline and over time. Countries currently involved include Australia, New Zealand, France, UK, USA, India, Spain, China and Canada, with more anticipated to follow. This collaborative approach to the collation and sharing of data will enable low-cost tracking of fast food composition around the world. This project represents a significant step forward in the objective and transparent monitoring of industry and government commitments to improve the quality of fast foods.
Publisher: Elsevier BV
Date: 07-2022
DOI: 10.1016/J.DIABET.2022.101331
Abstract: Canagliflozin reduces the risk, and progression, of diabetic kidney disease. We hypothesized that it may improve the microvascular complication of neuropathy. The CREDENCE trial randomized participants with type 2 diabetes and kidney disease to canagliflozin 100 mg daily or placebo. Neuropathy events were defined post-hoc as any reported adverse event consistent with a peripheral or autonomic neuropathy event. The effect of canagliflozin and predictors of neuropathy events were estimated using Cox regression analysis. In sensitivity analyses the endpoint was restricted to sensorimotor polyneuropathy, diabetic neuropathy, and non-autonomic neuropathy events. Almost half (48.8%) of the 4401 participants had a diagnosis of neuropathy at baseline. Over a median of 2.45 years of follow up, 657 people experienced a neuropathy event (63.2 per 1000 patient-years). Independent factors associated with higher risk of experiencing neuropathy events were non-white race, younger age, higher glycated haemoglobin and lower estimated glomerular filtration rate. The incidence of neuropathy events was similar in people randomized to canagliflozin and placebo (334/2202 vs. 323/2199 HR 1.04, 95% CI 0.89 to 1.21, P = 0.66). Canagliflozin had no impact on sensorimotor polyneuropathy (HR 0.93, 95% CI 0.69 to 1.25, P = 0.63), diabetic neuropathy (HR 0.91, 95% CI 0.68 to 1.22, P = 0.52), or non-autonomic neuropathy (HR 1.03, 95% CI 0.87 to 1.21, P = 0.77). The lack of effect on neuropathy events was consistent in subgroup analyses. Canagliflozin did not affect the risk of neuropathy events in the CREDENCE trial. Future large randomized studies with prespecified neuropathy endpoints are required to determine the impact of sodium glucose cotransporter 2 inhibitors on diabetic neuropathy.
Publisher: BMJ
Date: 30-04-2009
DOI: 10.1136/BMJ.B1492
Publisher: Springer Science and Business Media LLC
Date: 20-08-2021
DOI: 10.1007/S00125-021-05512-5
Abstract: Higher plasma concentrations of tumour necrosis factor receptor (TNFR)-1, TNFR-2 and kidney injury molecule-1 (KIM-1) have been found to be associated with higher risk of kidney failure in in iduals with type 2 diabetes in previous studies. Whether drugs can reduce these biomarkers is not well established. We measured these biomarkers in s les of the CANVAS study and examined the effect of the sodium–glucose cotransporter 2 inhibitor canagliflozin on these biomarkers and assessed whether the early change in these biomarkers predict cardiovascular and kidney outcomes in in iduals with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS). Biomarkers were measured with immunoassays (proprietary multiplex assay performed by RenalytixAI, New York, NY, USA) at baseline and years 1, 3 and 6. Mixed-effects models for repeated measures assessed the effect of canagliflozin vs placebo on the biomarkers. Associations of baseline levels and the early change (baseline to year 1) for each biomarker with the kidney outcome were assessed using multivariable-adjusted Cox regression. In total, 3523/4330 (81.4%) of the CANVAS participants had available s les at baseline. Each doubling in baseline TNFR-1, TNFR-2 and KIM-1 was associated with a higher risk of kidney outcomes, with corresponding HRs of 3.7 (95% CI 2.3, 6.1 p 0.01), 2.7 (95% CI 2.0, 3.6 p 0.01) and 1.5 (95% CI 1.2, 1.8 p 0.01), respectively. Canagliflozin reduced the level of the plasma biomarkers with differences in TNFR-1, TNFR-2 and KIM-1 between canagliflozin and placebo during follow-up of 2.8% (95% CI 3.4%, 1.3% p 0.01), 1.9% (95% CI 3.5%, 0.2% p = 0.03) and 26.7% (95% CI 30.7%, 22.7% p 0.01), respectively. Within the canagliflozin treatment group, each 10% reduction in TNFR-1 and TNFR-2 at year 1 was associated with a lower risk of the kidney outcome (HR 0.8 [95% CI 0.7, 1.0 p = 0.02] and 0.9 [95% CI 0.9, 1.0 p 0.01] respectively), independent of other patient characteristics. The baseline and 1 year change in biomarkers did not associate with cardiovascular or heart failure outcomes. Canagliflozin decreased KIM-1 and modestly reduced TNFR-1 and TNFR-2 compared with placebo in in iduals with type 2 diabetes in CANVAS. Early decreases in TNFR-1 and TNFR-2 during canagliflozin treatment were independently associated with a lower risk of kidney disease progression, suggesting that TNFR-1 and TNFR-2 have the potential to be pharmacodynamic markers of response to canagliflozin.
Publisher: Springer Science and Business Media LLC
Date: 10-07-2013
Publisher: Springer Science and Business Media LLC
Date: 26-07-2023
DOI: 10.1007/S00394-023-03210-Z
Abstract: To assess any effects of a state-wide sodium reduction intervention on sodium intake, sources of dietary sodium and discretionary salt use at a population level. Data (24-h urinary sodium excretion, self-report survey, a 24-h dietary recall) were collected cross-sectionally at baseline (2016/2017) and follow-up (2020) from adults in Victoria, Australia. Intervention activities included consumer awareness advertising c aign, public debate generation via mass media, strengthening existing policy initiatives and supporting food innovation with industry. There were 339 participants at baseline and 211 at follow-up, with 144 and 90 of participants completing a 24-h dietary recall, respectively. There was no difference in adjusted 24-h urinary sodium excretion between baseline and follow-up (134 vs 131 mmol/24 h p = 0.260). There were no differences in the percentage of participants adding salt during cooking (63% vs 68% p = 0.244), adding salt at the table (34% vs 37% p = 0.400) or regularly taking action to control salt/sodium intake (22% vs 21% p = 0.793). There were large differences in the quantity of dietary sodium sourced from retail stores (57% vs 77%, p 0.001), and less sodium was sourced from foods at fresh food markets (13% vs 2% p ≤ 0.001) at follow-up. No large differences were apparent for foods with different levels of processing or for food groups. There was no clear population-level effect of the 4-year multi-component Victorian Salt Reduction Intervention on sodium intake with Victorian adults continuing to consume sodium above recommended levels. The findings indicate that more intensive and sustained efforts aiming at the retail and food industry with national level support are likely to be required to achieve a measurable improvement in sodium intake at a state level.
Publisher: Oxford University Press (OUP)
Date: 28-01-2011
Publisher: SAGE Publications
Date: 02-2017
Abstract: Understanding patients’ perspective towards HIV screening in Malaysia is pivotal to explore challenges faced by these in iduals. This would be beneficial for developing local plans to improve the health-seeking behaviours among population at risk of HIV/AIDS. A qualitative research methodology was adopted to explore HIV/AIDS patients’ views about disease screening. A semi-structured interview guide was used for in-depth patient interviews. All interviews were audio-recorded and were subjected to a standard content analysis framework for data analysis. Most patients were positive about screening and the value of knowing about their status early. However, fear of social stigma, discrimination, lack of support system and lack of public understanding were identified as major concerns affecting their willingness to be screened. They were concerned about mandatory screening being implemented without improvement in support system and public education. Reluctance to seek HIV screening is an important factor contributing to transmission in developing countries. In the Malaysian context, efforts should be made to strengthen screening strategies especially in the most-at-risk populations to monitor the epidemic and target prevention strategies. In a multicultural context, HIV preventive strategies must include disease awareness, including measure to tackle barriers towards screening.
Publisher: Elsevier BV
Date: 03-2021
Publisher: Springer Science and Business Media LLC
Date: 06-10-2010
DOI: 10.1007/S00134-010-2039-6
Abstract: To determine the effect of random assignment to fluid resuscitation with albumin or saline on organ function and mortality in patients with severe sepsis. Pre-defined subgroup analysis of a randomized controlled trial conducted in the intensive care units of 16 hospitals in Australia and New Zealand. Of 1,218 patients with severe sepsis at baseline, 603 and 615 were assigned to receive albumin and saline, respectively. The two groups had similar baseline characteristics. During the first 7 days mean arterial pressure was similar in the two groups, but patients assigned albumin had a lower heart rate on days 1 and 3 (p = 0.002 and p = 0.03, respectively) and a higher central venous pressure on days 1-3 (p < 0.005 each day). There was no difference in the renal or total Sequential Organ Failure Assessment score of the two groups 113/603 (18.7%) of patients assigned albumin were treated with renal replacement therapy compared to 112/615 (18.2%) assigned saline (p = 0.98). The unadjusted relative risk of death for albumin versus saline was 0.87 [95% confidence interval (CI) 0.74-1.02] for patients with severe sepsis and 1.05 (0.94-1.17) for patients without severe sepsis (p = 0.06 for heterogeneity). From multivariate logistic regression analysis adjusting for baseline factors in patients with complete baseline data (919/1,218, 75.5%), the adjusted odds ratio for death for albumin versus saline was 0.71 (95% CI: 0.52-0.97 p = 0.03). Administration of albumin compared to saline did not impair renal or other organ function and may have decreased the risk of death.
Publisher: Elsevier BV
Date: 07-2020
Publisher: Elsevier BV
Date: 11-2012
DOI: 10.1016/J.JACC.2012.07.049
Abstract: The purpose of this systematic review and meta-analysis was to determine the efficacy and safety of fibrate therapy in the chronic kidney disease (CKD) population. Fibrate therapy produces modest cardiovascular benefits in people at elevated cardiovascular risk. There is limited evidence about the clinical benefits and safety of fibrate therapy in the CKD population. MEDLINE, EMBASE, and the Cochrane Library were systematically searched (1950 to January 2012) for prospective randomized controlled trials assessing the effects of fibrate therapy compared with placebo in people with CKD or on kidney-related outcomes were included. Ten studies including 16,869 participants were identified. In patients with mild-to-moderate CKD (estimated glomerular filtration rate [eGFR] ≤60 ml/min/1.73 m(2)), fibrates improved lipid profiles (lowered total cholesterol [-0.32 mmol/l, p = 0.05] and triglyceride levels [-0.56 mmol/l, p = 0.03] but not low-density lipoprotein cholesterol [-0.01 mmol/l, p = 0.83] increased high-density lipoprotein cholesterol [0.06 mmol/l, p = 0.001]). In people with diabetes, fibrates reduced the risk of albuminuria progression (relative risk [RR]: 0.86 95% confidence interval [CI]: 0.76 to 0.98 p = 0.02). Serum creatinine was elevated by fibrate therapy (33 μmol/l, p < 0.001), calculated GFR was reduced (-2.67 ml/min/1.73 m(2), p = 0.01) but there was no detectable effect on the risk of end-stage kidney disease (RR: 0.85 95% CI: 0.49 to 1.49 p = 0.575). In patients with eGFR of 30 to 59.9 ml/min/1.73 m(2), fibrates reduced the risk of major cardiovascular events (RR: 0.70 95% CI: 0.54 to 0.89 p = 0.004) and cardiovascular death (RR: 0.60 95% CI: 0.38 to 0.96 p = 0.03) but not all-cause mortality. There were no clear safety concerns specific to people with CKD but available data were limited. Fibrates improve lipid profiles and prevent cardiovascular events in people with CKD. They reduce albuminuria and reversibly increase serum creatinine but the effects on major kidney outcomes remain unknown. These results suggest that fibrates have a place in reducing cardiovascular risk in people with mild-to-moderate CKD.
Publisher: Cambridge University Press (CUP)
Date: 28-12-2021
DOI: 10.1017/S1368980020005273
Abstract: To assess the contribution of different food groups to total salt purchases and to evaluate the estimated reduction in salt purchases if mandatory maximum salt limits in South African legislation were being complied with. This study conducted a cross-sectional analysis of purchasing data from Discovery Vitality members. Data were linked to the South African FoodSwitch database to determine the salt content of each food product purchased. Food category and total annual salt purchases were determined by summing salt content (kg) per each unit purchased across a whole year. Reductions in annual salt purchases were estimated by applying legislated maximum limits to product salt content. South Africa. The study utilised purchasing data from 344 161 households, members of Discovery Vitality, collected for a whole year between January and December 2018. Vitality members purchased R12·8 billion worth of food products in 2018, representing 9562 products from which 264 583 kg of salt was purchased. The main contributors to salt purchases were bread and bakery products (23·3 %) meat and meat products (19 %) dairy (12·2 %) sauces, dressings, spreads and dips (11·8 %) and convenience foods (8·7 %). The projected total quantity of salt that would be purchased after implementation of the salt legislation was 250 346 kg, a reduction of 5·4 % from 2018 levels. A projected reduction in salt purchases of 5·4 % from 2018 levels suggests that meeting the mandatory maximum salt limits in South Africa will make a meaningful contribution to reducing salt purchases.
Publisher: Public Library of Science (PLoS)
Date: 08-04-2008
Publisher: Cambridge University Press (CUP)
Date: 29-01-2020
DOI: 10.1017/S000711452000032X
Abstract: In Victoria, Australia, a statewide salt reduction partnership was launched in 2015. The aim was to measure Na intake, food sources of Na (level of processing, purchase origin) and discretionary salt use in a cross-section of Victorian adults prior to a salt reduction initiative. In 2016/2017, participants completed a 24-h urine collection ( n 338) and a subs le completed a 24-h dietary recall ( n 142). Participants were aged 41·2 ( sd 13·9) years, and 56 % were females. Mean 24-h urinary excretion was 138 (95 % CI 127, 149) mmol/d for Na. Salt equivalent was 8·1 (95 % CI 7·4, 8·7) g/d, equating to about 8·9 (95 % CI 8·1, 9·6) g/d after 10 % adjustment for non-urinary losses. Mean 24-h intake estimated by diet recall was 118 (95 % CI 103, 133) mmol/d for Na (salt 6·9 (95 % CI 6·0, 7·8 g/d)). Leading dietary sources of Na were cereal-based mixed dishes (12 %), English muffins, flat/savoury/sweet breads (9 %), regular breads/rolls (9 %), gravies and savoury sauces (7 %) and processed meats (7 %). Over one-third (38 %) of Na consumed was derived from discretionary foods. Half of all Na consumed came from ultra-processed foods. Dietary Na derived from foods was obtained from retail stores (51 %), restaurants and fast-food/takeaway outlets (28 %) and fresh food markets (9 %). One-third (32 %) of participants reported adding salt at the table and 61 % added salt whilst cooking. This study revealed that salt intake was above recommended levels with erse sources of intake. Results from this study suggest a multi-faceted salt reduction strategy focusing on the retail sector, and food reformulation would most likely benefit Victorians and has been used to inform the ongoing statewide salt reduction initiative.
Publisher: Wiley
Date: 29-10-2021
DOI: 10.1111/DOM.14226
Publisher: American Diabetes Association
Date: 2011
DOI: 10.2337/DC10-1270
Abstract: To assess the utility of a point-of-care (POC) capillary blood glucose measurement as compared with routine clinical parameters in predicting undiagnosed diabetes in a low-resource rural India setting. Nine hundred and ninety-four participants aged & years and stratified by age and sex were randomly selected from 20 villages in India. A clinical questionnaire, s ling for laboratory venous fasting plasma glucose (FPG), and POC capillary blood glucose assay were performed simultaneously. Diabetes diagnosis was based on the World Health Organization (WHO) definition using FPG. The capacity of the POC glucose to predict the presence of diabetes was assessed and compared with the questionnaire using area under the receiver operating characteristic curves (AUCs). The AUC for POC glucose alone in predicting diabetes was 0.869 (95% CI 0.810–0.929). This was significantly better (P & 0.001 for AUC comparison) than the models based upon clinical variables alone (AUC for the best clinical model including age, BMI, hypertension, waist circumference: 0.694 [95% CI 0.621–0.766]). POC glucose appropriately reclassified the risk of up to one-third of participants ranked according to the clinical models. Adding the clinical variables to the POC glucose assay did not significantly improve the discriminatory capability beyond that achieved with the POC glucose measurement alone (all P & 0.37). POC glucose testing appears to be a simple and reliable tool for identifying undiagnosed diabetes in a high-risk, resource-poor rural population. However, studies evaluating the cost effectiveness of introducing POC glucose testing are needed prior to widespread implementation.
Publisher: Springer Science and Business Media LLC
Date: 12-03-2019
Publisher: American College of Physicians
Date: 07-07-2015
DOI: 10.7326/L15-5103-2
Publisher: Elsevier BV
Date: 04-2020
Publisher: Springer Science and Business Media LLC
Date: 14-01-2011
Abstract: Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based s le of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at risk of CVD. In addition it will also precisely and reliably define the effects of the intervention upon aspects of cognitive function that are likely to be affected early in at risk in iduals, using sensitive and responsive measures. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077
Publisher: Springer Science and Business Media LLC
Date: 15-07-2003
DOI: 10.1007/S00125-003-1167-8
Abstract: To estimate the prevalence of diagnosed and undiagnosed diabetes and impaired fasting glucose in the general adult population of China. The International Collaborative Study of Cardiovascular Disease in ASIA, conducted from 2000 to 2001, included a nationally representative s le of 15 540 adults, aged 35 to 74 years. An overnight fasting blood specimen was collected to measure serum glucose and information on history of diabetes and use of hypoglycaemic medications was obtained by a standard questionnaire. Undiagnosed diabetes (fasting glucose > or =7.0 mmol/l) and impaired fasting glucose (6.1-6.9 mmol/l) were defined using the American Diabetes Association criteria. Prevalence of self-reported diagnosed diabetes, undiagnosed diabetes, and impaired fasting glucose in Chinese adults were 1.3%, 4.2%, and 7.3%, respectively. Overall, 5.2% or 12.7 million men and 5.8% or 13.3 million women in China aged 35 to 74 years had diabetes (self-reported diagnosis plus undiagnosed diabetes). The age-standardized prevalence of diabetes was higher in residents of northern compared to southern China (7.4% vs 5.4%, p<0.001) and in those living in urban compared to rural areas (7.8% vs 5.1%, p<0.001). Our results show that the prevalence of diabetes in the adult population in China is much higher than previously reported. Three out of every four diabetes patients are undiagnosed, indicative of a lack of population-based screening programmmes and a relatively rapid and recent increase in incidence of diabetes. These results indicate that diabetes has become a major public health problem in China and underscore the need for national strategies aimed at prevention and treatment of diabetes.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 31-07-2018
DOI: 10.1161/CIRCULATIONAHA.118.034222
Abstract: Canagliflozin is a sodium glucose cotransporter 2 inhibitor that reduces the risk of cardiovascular events. We report the effects on heart failure (HF) and cardiovascular death overall, in those with and without a baseline history of HF, and in other participant subgroups. The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomly assigned to canagliflozin or placebo and followed for a mean of 188 weeks. The primary end point for these analyses was adjudicated cardiovascular death or hospitalized HF. Participants with a history of HF at baseline (14.4%) were more frequently women, white, and hypertensive and had a history of prior cardiovascular disease (all P .001). Greater proportions of these patients were using therapies such as blockers of the renin angiotensin aldosterone system, diuretics, and β-blockers at baseline (all P .001). Overall, cardiovascular death or hospitalized HF was reduced in those treated with canagliflozin compared with placebo (16.3 versus 20.8 per 1000 patient-years hazard ratio [HR], 0.78 95% confidence interval [CI], 0.67–0.91), as was fatal or hospitalized HF (HR, 0.70 95% CI, 0.55–0.89) and hospitalized HF alone (HR, 0.67 95% CI, 0.52–0.87). The benefit on cardiovascular death or hospitalized HF may be greater in patients with a prior history of HF (HR, 0.61 95% CI, 0.46–0.80) compared with those without HF at baseline (HR, 0.87 95% CI, 0.72–1.06 P interaction =0.021). The effects of canagliflozin compared with placebo on other cardiovascular outcomes and key safety outcomes were similar in participants with and without HF at baseline (all interaction P values .130), except for a possibly reduced absolute rate of events attributable to osmotic diuresis among those with a prior history of HF ( P =0.03). In patients with type 2 diabetes mellitus and an elevated risk of cardiovascular disease, canagliflozin reduced the risk of cardiovascular death or hospitalized HF across a broad range of different patient subgroups. Benefits may be greater in those with a history of HF at baseline. URL: www.clinicaltrials.gov . Unique identifiers: NCT01032629 and NCT01989754.
Publisher: Oxford University Press (OUP)
Date: 25-02-2022
Publisher: Informa UK Limited
Date: 19-02-2015
Publisher: Massachusetts Medical Society
Date: 23-11-2017
DOI: 10.1056/NEJMC1712572
Publisher: Public Library of Science (PLoS)
Date: 04-02-2013
Publisher: Springer Science and Business Media LLC
Date: 12-2017
Publisher: Elsevier BV
Date: 11-2010
DOI: 10.1016/J.AHJ.2010.08.012
Abstract: Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Patients with advanced CKD (blood creatinine ≥ 1.7 mg/dL [≥ 150 μmol/L] in men or ≥ 1.5 mg/dL [ ≥ 130 μmol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events, defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.
Publisher: Springer Science and Business Media LLC
Date: 28-10-2021
DOI: 10.1186/S12966-021-01208-6
Abstract: Countries around the world are putting in place sugar reformulation targets for packaged foods to reduce excess sugar consumption. The Australian government released its voluntary sugar reformulation targets for nine food categories in 2020. We estimated the potential impact of these targets on household sugar purchases and examined differences by income. For comparison, we also modelled the potential impact of the UK sugar reduction targets on per capita sugar purchases as the UK has one of the most comprehensive sugar reduction strategies in the world. Grocery purchase data from a nationally representative consumer panel ( n =7,188) in Australia was linked with a large database (FoodSwitch) with product-specific sugar content information for packaged foods ( n =25,261) both datasets were collected in 2018. Potential reductions in per capita sugar purchases were calculated overall and by food category. Differences in sugar reduction across income level were assessed by analysis of variance. In 2018, the total sugar acquired from packaged food and beverage purchases consumed at-home was 56.1 g/day per capita. Australia’s voluntary reformulation targets for sugar covered 2,471/25,261 (9.8%) unique products in the FoodSwitch dataset. Under the scenario that all food companies adhered to the voluntary targets, sugar purchases were estimated to be reduced by 0.9 g/day per capita, which represents a 1.5% reduction in sugar purchased from packaged foods. However, if Australia adopted the UK targets, over twice as many products would be covered ( n =4,667), and this would result in a more than four times greater reduction in sugar purchases (4.1 g/day per capita). It was also estimated that if all food companies complied with Australia’s voluntary sugar targets, reductions to sugar would be slightly greater in low-income households compared with high-income households by 0.3 g/day (95%CI 0.2 - 0.4 g/day, p .001). Sugar-reduction policies have the potential to substantially reduce population sugar consumption and may help to reduce health inequalities related to excess sugar consumption. However, the current reformulation targets in Australia are estimated to achieve only a small reduction to sugar intakes, particularly in comparison to the UK’s sugar reduction program.
Publisher: Oxford University Press (OUP)
Date: 21-01-2016
DOI: 10.1093/IJE/DYV313
Abstract: Estimating equations based on spot urine s les have been identified as a possible alternative approach to 24-h urine collections for determining mean population salt intake. This review compares estimates of mean population salt intake based upon spot and 24-h urine s les. We systematically searched for all studies that reported estimates of daily salt intake based upon both spot and 24-h urine s les for the same population. The associations between the two were quantified and compared overall and in subsets of studies. A total of 538 records were identified, 108 were assessed as full text and 29 were included. The included studies involved 10,414 participants from 34 countries and made 71 comparisons available for the primary analysis. Overall average population salt intake estimated from 24-h urine s les was 9.3 g/day compared with 9.0 g/day estimated from the spot urine s les. Estimates based upon spot urine s les had excellent sensitivity (97%) and specificity (100%) at classifying mean population salt intake as above or below the World Health Organization maximum target of 5 g/day. Compared with the 24-h s les, estimates based upon spot urine overestimated intake at lower levels of consumption and underestimated intake at higher levels of consumption. Estimates of mean population salt intake based upon spot urine s les can provide countries with a good indication of mean population salt intake and whether action on salt consumption is required.
Publisher: Elsevier BV
Date: 07-2000
Publisher: Elsevier BV
Date: 07-2021
Publisher: BMJ
Date: 04-12-2014
Publisher: Elsevier BV
Date: 03-2019
DOI: 10.1016/J.YPMED.2019.01.009
Abstract: Sugar-sweetened beverage (SSB) intake is associated with tooth decay, obesity and diabetes. We aimed to model the health and cost impact of reducing the serving size of all single serve SSB to a maximum of 250 ml in New Zealand. A 250 ml serving size cap was modeled for all instances of single serves (<600 ml) of sugar-sweetened carbonated soft drinks, fruit drinks, carbonated energy drinks, and sports drinks in the New Zealand National Nutrition Survey intake data (2008/09). A multi-state life-table model used the change in energy intake and therefore BMI to predict the resulting health gains in quality-adjusted life-years (QALYs) and health system costs over the remaining life course of the New Zealand population alive in 2011 (N = 4.4 million, 3% discounting). The 'base case' model (no compensation for reduced energy intake) resulted in an average reduction in SSB and energy intake of 23 ml and 44 kJ (11 kcal) per day or 0.22 kg of weight modeled over two years. The total health gain and cost-savings were 82,100 QALYs (95% UI: 65100 to 101,000) and NZ$1.65 billion [b] (95% UI: 1.19 b to 2.24 b, (US$1.10 b)) over the lifespan of the cohort. QALY gains increased to 116,000 when the SSB definition was widened to include fruit juices and sweetened milks. A cap on single serve SSB could be an effective part of a suite of obesity prevention and sugar reduction interventions in high income countries.
Publisher: Elsevier BV
Date: 10-2023
Publisher: Springer Science and Business Media LLC
Date: 09-2001
Abstract: Patients with Type II (non-insulin-dependent) diabetes mellitus are at increased risk of macrovascular and microvascular disease, both of which are reduced by controlling raised blood pressure in hypertensive patients. Intensive glycaemic control has also been shown to reduce microvascular disease but the effects on macrovascular disease remain uncertain. This study will examine the hypotheses that lowering blood pressure with an ACE inhibitor-diuretic combination and intensively controlling gylcaemia with a sulphonylurea-based regimen in high-risk patients with Type II diabetes (both hypertensive and non-hypertensive) reduces the incidence of macrovascular and microvascular disease. The study is a 2 x 2 factorial randomised controlled trial that will include 10000 adults with Type II diabetes at high risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible patients are randomised to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regimen or usual guidelines-based therapy. Primary outcomes are, first, the composite of nonfatal stroke, non-fatal myocardial infarction or cardiovascular death and, second, the composite of new or worsening nephropathy or diabetic eye disease. The scheduled average duration of treatment and follow-up is 4.5 years. The study will be conducted in approximately 200 centres in Australasia, Asia, Europe and North America. ADVANCE is designed to provide reliable evidence on the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, regardless of initial blood pressure or glucose concentrations.
Publisher: Springer Science and Business Media LLC
Date: 26-08-2021
DOI: 10.1007/S00125-021-05524-1
Abstract: Type 2 diabetes mellitus can manifest over a broad clinical range, although there is no clear consensus on the categorisation of disease complexity. We assessed the effects of canagliflozin, compared with placebo, on cardiovascular and kidney outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program over a range of type 2 diabetes mellitus complexity, defined separately by baseline intensity of treatment, duration of diabetes and glycaemic control. We performed a post hoc analysis of the effects of canagliflozin on major adverse cardiovascular events (MACE) according to baseline glucose-lowering treatments (0 or 1, 2 or 3+ non-insulin glucose-lowering treatments, or insulin-based treatment), duration of diabetes ( , 10 to 16, years) and HbA 1c (≤53.0 mmol/mol [ .0%], .0 to 58.5 mmol/mol [ .0% to 7.5%], .5 to 63.9 mmol/mol [ .5 to 8.0%], .9 to 69.4 mmol/mol [8.0% to 8.5%], .4 to 74.9 mmol/mol [ .5 to 9.0%] or .9 mmol/mol [ .0%]). We analysed additional secondary endpoints for cardiovascular and kidney outcomes, including a combined kidney outcome of sustained 40% decline in eGFR, end-stage kidney disease or death due to kidney disease. We used Cox regression analyses and compared the constancy of HRs across subgroups by fitting an interaction term ( p value for significance .05). At study initiation, 5095 (50%) CANVAS Program participants were treated with insulin, 2100 (21%) had an HbA 1c 74.9 mmol/mol (9.0%) and the median duration of diabetes was 12.6 years (interquartile interval 8.0–18 years). Canagliflozin reduced MACE (HR 0.86 [95% CI 0.75, 0.97]) with no evidence that the benefit differed between subgroups defined by the number of glucose-lowering treatments, the duration of diabetes or baseline HbA 1c (all p-heterogeneity .17). Canagliflozin reduced MACE in participants receiving insulin with no evidence that the benefit differed from other participants in the trial (HR 0.85 [95% CI 0.72, 1.00]). Similar results were observed for other cardiovascular outcomes and for the combined kidney outcome (HR for combined kidney outcome 0.60 [95% CI 0.47, 0.77]), with all p-heterogeneity .37. In people with type 2 diabetes mellitus at high cardiovascular risk, there was no evidence that cardiovascular and renal protection with canagliflozin differed across subgroups defined by baseline treatment intensity, duration of diabetes or HbA 1c .
Publisher: Public Library of Science (PLoS)
Date: 21-08-2012
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 27-08-2019
DOI: 10.1161/CIRCULATIONAHA.119.042007
Abstract: Canagliflozin reduces the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, but effects on specific cardiovascular outcomes are uncertain, as are effects in people without previous cardiovascular disease (primary prevention). In CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation), 4401 participants with type 2 diabetes mellitus and chronic kidney disease were randomly assigned to canagliflozin or placebo on a background of optimized standard of care. Primary prevention participants (n=2181, 49.6%) were younger (61 versus 65 years), were more often female (37% versus 31%), and had shorter duration of diabetes mellitus (15 years versus 16 years) compared with secondary prevention participants (n=2220, 50.4%). Canagliflozin reduced the risk of major cardiovascular events overall (hazard ratio [HR], 0.80 [95% CI, 0.67–0.95] P =0.01), with consistent reductions in both the primary (HR, 0.68 [95% CI, 0.49–0.94]) and secondary (HR, 0.85 [95% CI, 0.69–1.06]) prevention groups ( P for interaction=0.25). Effects were also similar for the components of the composite including cardiovascular death (HR, 0.78 [95% CI, 0.61–1.00]), nonfatal myocardial infarction (HR, 0.81 [95% CI, 0.59–1.10]), and nonfatal stroke (HR, 0.80 [95% CI, 0.56–1.15]). The risk of the primary composite renal outcome and the composite of cardiovascular death or hospitalization for heart failure were also consistently reduced in both the primary and secondary prevention groups ( P for interaction .5 for each outcome). Canagliflozin significantly reduced major cardiovascular events and kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, including in participants who did not have previous cardiovascular disease. URL: www.clinicaltrials.gov . Unique identifier: NCT02065791.
Publisher: Springer Science and Business Media LLC
Date: 23-06-2020
DOI: 10.1186/S12966-020-00982-Z
Abstract: The Australian federal government will soon release voluntary sodium reduction targets for 30 packaged food categories through the Healthy Food Partnership. Previous assessments of voluntary targets show variable industry engagement, and little is known about the extent that major food companies and their products contribute to dietary sodium purchases among Australian households. The aim of this cross-sectional study was to identify the relative contribution that food companies and their products made to Australian household sodium purchases in 2018, and to examine differences in sodium purchases by household income level. We used 1 year of grocery purchase data from a nationally representative consumer panel of Australian households who reported their grocery purchases (the Nielsen Homescan panel), combined with database that contains product-specific sodium content for packaged foods and beverages (FoodSwitch). The top food companies and food categories were ranked according to their contribution to household sodium purchases. Differences in per capita sodium purchases by income levels were assessed by 1-factor ANOVA. All analyses were modelled to the Australian population in 2018 using s le weights. Sodium data were available from 7188 households who purchased 26,728 unique products and purchased just under 7.5 million food product units. Out of 1329 food companies, the top 10 accounted for 35% of unique products and contributed to 58% of all sodium purchased from packaged foods and beverages. The top three companies were grocery food retailers each contributing 12–15% of sodium purchases from sales of their private label products, particularly processed meat, cheese and bread. Out of the 67 food categories, the top 10 accounted for 73% of sodium purchased, particularly driven by purchases of processed meat (14%), bread (12%) and sauces (11%). Low-income Australian households purchased significantly more sodium from packaged products than high-income households per capita (452 mg/d, 95%CI: 363-540 mg/d, P 0.001). A small number of food companies and food categories account for most of the dietary sodium purchased by Australian households. Prioritizing government engagement with these groups could deliver a large reduction in population sodium intake.
Publisher: Massachusetts Medical Society
Date: 27-05-2004
DOI: 10.1056/NEJMOA040232
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-12-2021
Abstract: Studies have suggested that sodium glucose co‐transporter 2 inhibitors exert anti‐inflammatory effects. We examined the association of baseline growth differentiation factor‐15 (GDF‐15), a marker of inflammation and cellular injury, with cardiovascular events, hospitalization for heart failure (HF), and kidney outcomes in patients with type 2 diabetes in the CANVAS (Canagliflozin Cardiovascular Assessment Study) and determined the effect of the sodium glucose co‐transporter 2 inhibitor canagliflozin on circulating GDF‐15. The CANVAS trial randomized 4330 people with type 2 diabetes at high cardiovascular risk to canagliflozin or placebo. The association between baseline GDF‐15 and cardiovascular (non‐fatal myocardial infarction, non‐fatal stroke, cardiovascular death), HF, and kidney (40% estimated glomerular filtration rate decline, end‐stage kidney disease, renal death) outcomes was assessed using multivariable adjusted Cox regression models. During median follow‐up of 6.1 years (N=3549 participants with available s les), 555 cardiovascular, 129 HF, and 137 kidney outcomes occurred. Each doubling in baseline GDF‐15 was significantly associated with a higher risk of cardiovascular (hazard ratio [HR], 1.2 95% CI, 1.0‒1.3), HF (HR, 1.5 95% CI, 1.2‒2.0) and kidney (HR, 1.5 95% CI, 1.2‒2.0) outcomes. Baseline GDF‐15 did not modify canagliflozin’s effect on cardiovascular, HF, and kidney outcomes. Canaglifozin treatment modestly lowered GDF‐15 compared with placebo however, GDF‐15 did not mediate the protective effect of canagliflozin on cardiovascular, HF, or kidney outcomes. In patients with type 2 diabetes at high cardiovascular risk, higher GDF‐15 levels were associated with a higher risk of cardiovascular, HF, and kidney outcomes. Canagliflozin modestly lowered GDF‐15, but GDF‐15 reduction did not mediate the protective effect of canagliflozin.
Publisher: BMJ
Date: 07-2021
DOI: 10.1136/BMJOPEN-2020-045929
Abstract: Cardiovascular diseases (CVDs) are the leading causes of death and disability worldwide. Reducing dietary salt consumption is a potentially cost-effective way to reduce blood pressure and the burden of CVD. To date, economic evidence has focused on sodium reduction in food industry or processed food with blood pressure as the primary outcome. This study protocol describes the planned within-trial economic evaluation of a low-sodium salt substitute intervention designed to reduce the risk of stroke in China. The economic evaluation will be conducted alongside the Salt Substitute and Stroke Study: a 5-year large scale, cluster randomised controlled trial. The outcomes of interest are quality of life measured using the EuroQol-5-Dimensions and major adverse cardiovascular events. Costs will be estimated from a healthcare system perspective and will be sought from the routinely collected data available within the New Rural Cooperative Medical Scheme. Cost-effectiveness and cost-utility analyses will be conducted, resulting in the incremental cost-effectiveness ratio expressed as cost per cardiovascular event averted and cost per quality-adjusted life year gained, respectively. The trial received ethics approval from the University of Sydney Ethics Committee (2013/888) and Peking University Institutional Review Board (IRB00001052-13069). Informed consent was obtained from each study participant. Findings of the economic evaluation will be published in a peer-reviewed journal and presented at international conferences. ClinicalTrials.gov Registry ( NCT02092090 ).
Publisher: Cambridge University Press (CUP)
Date: 14-04-2015
DOI: 10.1017/S1368980015000968
Abstract: To compare the nutrient profile of packaged supermarket food products available in Australia and New Zealand. Eligibility to carry health claims and relationship between nutrient profile score and nutritional content were also evaluated. Nutritional composition data were collected in six major Australian and New Zealand supermarkets in 2012. Mean Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC) scores were calculated and the proportion of products eligible to display health claims was estimated. Regression analyses quantified associations between NPSC scores and energy density, saturated fat, sugar and sodium contents. NPSC scores were derived for 23 596 packaged food products (mean score 7·0, range −17 to 53). Scores were lower (better nutrient profile) for foods in Australia compared with New Zealand (mean 6·6 v . 7·8). Overall, 45 % of foods were eligible to carry health claims based on NPSC thresholds: 47 % in Australia and 41 % in New Zealand. However, less than one-third of dairy (32 %), meat and meat products (28 %) and bread and bakery products (27·5 %) were eligible to carry health claims. Conversely, % of convenience food products were eligible to carry health claims (82·5 %). Each two-unit higher NPSC score was associated with higher energy density (78 kJ/100 g), saturated fat (0·95 g/100 g), total sugar (1·5 g/100 g) and sodium (66 mg/100 g all P values ·001). Fewer than half of all packaged foods available in Australia and New Zealand in 2012 met nutritional criteria to carry health claims. The few healthy choices available in key staple food categories is a concern. Improvements in nutritional quality of foods through product reformulation have significant potential to improve population diets.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2011
DOI: 10.1161/STROKEAHA.110.606764
Abstract: Despite clear evidence that blood pressure (BP) lowering is effective for prevention of cardiovascular events among patients with isolated systolic hypertension and systolic–diastolic hypertension, there is ongoing uncertainty about its effects in those with isolated diastolic hypertension. The objective of the present analysis is to determine whether BP lowering provides benefits to patients with isolated diastolic hypertension. Patients with cerebrovascular disease and hypertension at baseline (n=4283) were randomly assigned to either active treatment (perindopril in all participants plus indapamide for those with neither an indication for nor a contraindication to a diuretic) or matching placebo(s). The primary outcome was total major vascular events. There were 1923 patients with isolated systolic hypertension (systolic BP ≥140 mm Hg and diastolic BP mm Hg), 315 with isolated diastolic hypertension (systolic BP mm Hg and diastolic BP ≥90 mm Hg), and 2045 with systolic–diastolic hypertension (systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg) at baseline. Active treatment reduced the relative risk of major vascular events by 27% (95% CI, 10% to 41%) among patients with isolated systolic hypertension, by 28% (−29% to 60%) among those with isolated diastolic hypertension, and by 32% (17% to 45%) among those with systolic–diastolic hypertension. There was no evidence of differences in the magnitude of the effects of treatment among different types of hypertension ( P homogeneity=0.89). BP lowering is likely to provide a similar level of protection against major vascular events for patients with isolated diastolic hypertension as for those with isolated systolic hypertension and systolic–diastolic hypertension. This trial was not registered because patients were enrolled before July 1, 2005.
Publisher: SAGE Publications
Date: 27-07-2023
DOI: 10.1177/00222429231193994
Abstract: A bankrupt buyer firm's interactions with its suppliers during bankruptcy have critical implications for both parties and for the broader economy, yet these interactions remain poorly understood. The authors build on research on buyer–supplier relationship dynamics to demonstrate that accommodative and exploitative velocities—the rate and direction of change in the corresponding acts—serve as signals affecting bankruptcy survival. They show how signal characteristics (i.e., the variability in accommodative and exploitative acts) and signaler characteristics (i.e., whether the party undertaking the acts is the buyer or its suppliers) moderate the impact of accommodative and exploitative velocities on bankruptcy survival. Study 1 examines the bankruptcy survival outcome of 310 U.S. bankruptcies over 14 years and finds that a 1% increase in accommodative (exploitative) velocity increases (decreases) the buyer's survival by 39% (33%). Further, variability in accommodative acts weakens their effect, and suppliers' (vs. the buyer's) accommodative and exploitative velocities are less deterministic of the buyer's bankruptcy survival. Study 2 uses a scenario-based experiment to shed light on the mechanism underlying the impact of the two velocities on bankruptcy survival. The findings from both studies demonstrate the key role played by buyer–supplier interactions in a buyer's bankruptcy survival.
Publisher: BMJ
Date: 08-2008
Abstract: Little is known about the burden or causes of injury in rural villages in India. To examine injury-related mortality and morbidity in villages in the state of Andhra Pradesh, India. A verbal-autopsy-based mortality surveillance study was used to collect mortality data on all ages from residents in 45 villages in 2003-2004. In early 2005, a morbidity survey in adults was carried out using stratified random s ling in 20 villages. Participants were asked about injuries sustained in the preceding 12 months. Both fatal and non-fatal injuries were coded using classification methods derived from ICD-10. Response rates for the mortality surveillance and morbidity survey were 98% and 81%, respectively. Injury was the second leading cause of death for all ages, responsible for 13% (95% CI 11% to 15%) of all deaths. The leading causes of fatal injury were self-harm (36%), falls (20%), and road traffic crashes (13%). Non-fatal injury was reported by 6.7% of survey participants, with the leading causes of injury being falls (38%), road traffic crashes (25%), and mechanical forces (16.1%). Falls were more common in women, with most (72.3%) attributable to slipping and tripping. Road traffic injuries were sustained mainly by men and were primarily the result of motorcycle crashes (48.8%). Injury is an important contributor to disease burden in rural India. The leading causes of injury-falls, road traffic crashes, and suicides-are all preventable. It is important that effective interventions are developed and implemented to minimize the impact of injury in this region.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2019
DOI: 10.1161/HYPERTENSIONAHA.118.12060
Abstract: Discontinuation of angiotensin-converting enzyme (ACE) inhibitor is recommended if patients experience ≥30% acute increase in serum creatinine after starting this therapy. However, the long-term effects of its continuation or discontinuation on major clinical outcomes after increases in serum creatinine are unclear. In the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation), 11 140 diabetes mellitus patients were randomly assigned to perindopril-indapamide or placebo after a 6-week active run-in period. The current study included 11 066 participants with 2 serum creatinine measurements recorded before and during the active run-in period (3 weeks apart). Acute increase in creatinine was determined using these 2 measurements and classified into 4 groups: increases in serum creatinine of %, 10% to 19%, 20% to 29%, and ≥30%. The primary study outcome was the composite of major macrovascular events, new or worsening nephropathy, and all-cause mortality. An acute increase in serum creatinine was associated with an elevated risk of the primary outcome ( P for trend .001). The hazard ratios were 1.11 (95% CI, 0.97–1.28) for those with an increase of 10% to 19%, 1.34 (1.07–1.66) for 20% to 29%, and 1.44 (1.15–1.81) for ≥30%, compared with %. However, there was no evidence of heterogeneity in the benefit of randomized treatment effects on the outcome across subgroups defined by acute serum creatinine increase ( P for heterogeneity=0.94). Acute increases in serum creatinine after starting perindopril-indapamide were associated with greater risks of subsequent major clinical outcomes. However, the continuation of angiotensin-converting enzyme inhibitor-based therapy reduced the long-term risk of major clinical outcomes, irrespective of acute increase in creatinine. URL: www.clinicaltrials.gov . Unique identifier: NCT00145925.
Publisher: Elsevier BV
Date: 09-2013
DOI: 10.1016/J.AHJ.2013.05.013
Abstract: Peroxisome proliferator-activated receptors (PPARs) regulate transcription of genes involved in glucose uptake, lipid metabolism, and inflammation. Aleglitazar is a potent dual PPAR agonist with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles and biomarkers of cardiovascular risk. The AleCardio trial examines whether the addition of aleglitazar to standard medical therapy reduces the risk of cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and recent acute coronary syndrome. AleCardio is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. A total of 7,228 patients were randomized to aleglitazar 150 μg or placebo daily in addition to standard medical therapy. The primary efficacy end point is time to the first event of cardiovascular death, myocardial infarction, or stroke. Principal safety end points are hospitalization due to heart failure and changes in renal function. Treatment will continue until 7,000 patients are followed up for at least 2.5 years and 950 primary end point events are adjudicated. AleCardio will establish whether the PPAR-α/γ agonist aleglitazar improves cardiovascular outcomes in patients with diabetes and high-risk coronary disease.
Publisher: Oxford University Press (OUP)
Date: 06-2020
DOI: 10.1093/NDT/GFAA142.P1019
Abstract: The skin’s hypertonic microenvironment has a hypothesized protective antimicrobial function that may be disrupted by SGLT2i. The association between sodium glucose cotransporter inhibitors (SGLT2i) and genital mycotic infections is well established, but it is not known if these agents increase the risk of other skin and soft tissue infections (SSTI). We aimed to describe SSTI in the CREDENCE trial, and determine whether canagliflozin affects the risk of skin and soft tissue infections (SSTIs) overall and in subgroups. We performed a post-hoc analysis of the CREDENCE trial that randomised people with type 2 diabetes and albuminuric stage 2 and 3 chronic kidney disease to either canagliflozin 100mg daily or placebo. Infections reported as adverse events were assessed by two blinded authors following predetermined criteria for SSTI with discrepancies resolved by consensus. We analysed the risks of SSTIs in the on-treatment population as the more conservative approach, with a sensitivity analysis conducted in the intention-to-treat population. Univariable time-to first-event regression models were assessed. Overall 373/4397 (8.5%) participants experienced 478 events comprising 252 bacterial skin infections (including 2 episodes of necrotising fasciitis), 94 fungal skin infections, 109 other skin infections and 23 soft tissue infections. Of these, 136/478 (28%) were serious. Drug was continued in 290/373 (78%) of first events, with similar frequency of subsequent events between groups (31/133 (23%) and 33/157 (21%) for those continuing canagliflozin and placebo respectively). In both cases of necrotising fasciitis, drug was withdrawn and the participants recovered.Canagliflozin did not increase the risk of SSTI (HR 0.85 [95% Confidence Interval (CI) 0.69-1.04] p=0.11) (Figure 1). Results were similar in the intention-to-treat population (HR 0.88 [95% CI 0.73-1.07] p=0.20), in analyses confined to serious SSTI (HR 0.83 [95% CI 0.58-1.21] p=0.33), and in the predefined subgroups. Although other studies suggest that SGLT2i may reduce the sodium content of the skin, we found that canagliflozin does not increase the risk of skin and soft tissue infections, overall or in any subgroup, in people with type 2 diabetes mellitus and albuminuric chronic kidney disease.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2005
DOI: 10.1161/01.HYP.0000151103.02424.C3
Abstract: B-type natriuretic peptide (BNP) and C-reactive protein (CRP) are elevated in persons at risk for congestive heart failure (CHF). However, limited data are available directly comparing BNP-related peptides and CRP in persons at risk of CHF. To evaluate amino terminal–pro-BNP (NT-proBNP) and CRP, separately and together, for assessment of risk of CHF, we performed a nested case-control study of the 6105 participants of the Perindopril pROtection aGainst REcurrent Stroke Study (PROGRESS), a placebo-controlled study of a perindopril-based blood pressure–lowering regimen among in iduals with previous stroke or transient ischemic attack (TIA). Each of 258 subjects who developed CHF resulting in death, hospitalization, or withdrawal of randomized therapy during a mean follow-up of 3.9 years was matched to 1 to 3 control subjects. NT-proBNP and CRP predicted CHF the odds ratio for subjects in the highest compared with the lowest quarter was 4.5 (95% confidence interval, 2.7 to 7.5) for NT-proBNP and 2.9 (confidence interval, 1.9 to 4.7) for CRP, and each remained a predictor of CHF after adjustment for all other predictors. Screening for both markers provided better prognostic information than screening for either alone. Elevation of NT-proBNP above 50 pmol/L and CRP above 0.84 mg/L predicted CHF with sensitivity of 64% and specificity of 66%. NT-proBNP and CRP predicted CHF in subjects receiving perindopril-based therapy. We conclude that NT-proBNP and CRP are independent predictors of CHF risk after stroke or TIA. Moreover, NT-proBNP and CRP may be markers of mechanisms of CHF pathogenesis distinct from those responsive to angiotensin-converting enzyme inhibitor–based therapy.
Publisher: Elsevier BV
Date: 11-2022
DOI: 10.1016/J.JACC.2022.08.772
Abstract: People with type 2 diabetes mellitus (T2DM) have elevated cardiovascular (CV) risk, including for hospitalization for heart failure (HHF). Canagliflozin reduced CV and kidney events in patients with T2DM and high CV risk or nephropathy in the CANVAS (CANagliflozin cardioVascular Assessment Study) Program and the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. The aim of this study was to assess the effects of canagliflozin on CV outcomes according to baseline estimated glomerular filtration rate (eGFR) and urine albumin:creatinine ratio (UACR) in pooled patient-level data from the CANVAS Program and CREDENCE trial. Canagliflozin effects on CV death or HHF were assessed by baseline eGFR ( 60 mL/min/1.73 m A total of 14,543 participants from the CANVAS Program (N = 10,142) and the CREDENCE (N = 4,401) trial were included, with a mean age of 63 years, 35% female, 75% White, 13.2% with baseline eGFR <45 mL/min/1.73 m Risk of CV death or HHF was higher in those with lower baseline eGFR and/or higher UACR. Canagliflozin consistently reduced CV death or HHF in participants with T2DM and high CV risk or nephropathy regardless of baseline renal function or level of albuminuria. (Canagliflozin Cardiovascular Assessment Study [CANVAS], NCT01032629 A Study of the Effects of Canagliflozin [JNJ-24831754] on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus [CANVAS-R], NCT01989754 and Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy [CREDENCE], NCT02065791).
Publisher: Informa UK Limited
Date: 1999
DOI: 10.3109/10641969909060985
Abstract: Overviews (meta-analyses) of the major ongoing randomized trials of blood pressure lowering drugs will be conducted to determine the effects of: first, newer versus older classes of blood pressure lowering drugs in patients with hypertension and second, blood pressure lowering treatments versus untreated or less treated control conditions in patient groups at high risk of cardiovascular events. The principal study outcomes are stroke, coronary heart disease, total cardiovascular events and total cardiovascular deaths. The overviews have been prospectively designed and will be conducted on in idual patient data. The analyses will be conducted as a collaboration between the principal investigators of participating trials involving about 270,000 patients. Full data should be available in 2003, with the first round of analyses performed in 1999-2000. The combination of trial results should provide good statistical power to detect even modest differences between the effects on the main study outcomes.
Publisher: American Diabetes Association
Date: 23-06-2015
DOI: 10.2337/DC15-ER07A
Publisher: Oxford University Press (OUP)
Date: 21-11-2014
Abstract: The Chinese government launched a voluntary nutrition labelling code in 2007 and made it mandatory since 1 January 2013. This article aims to quantify the prevalence of nutrition labels and the completeness of nutrient declarations on pre-packaged foods in China and to explore the impact of the 2007 code. A systematic search of the published and grey literature was done, and a random-effects meta-analysis was used to obtain summary estimates. There were 15 surveys identified from 13 reports. For 44% (95% confidence interval: 37-51%) of the 22 636 food items, the product label provided information on one or more nutrients. There was significant heterogeneity between the surveys (I(2) = 99%, P < 0.001) raising some uncertainty about the reliability of the estimate. The heterogeneity was in part explained by differences in labelling between food categories (P < 0.001) but not by changes in the prevalence of nutrition labels over time (P = 0.36). Most pre-packaged foods in this survey had a nutrition label non-compliant with current Chinese nutrition labelling standards. The voluntary code launched in 2007 had limited impact on nutrition labelling. There is significant scope for the recently introduced mandatory labelling requirements to improve nutrition labelling in China.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-1997
Publisher: SAGE Publications
Date: 06-2003
DOI: 10.1177/021849230301100224
Abstract: The prevalence of diabetes is increasing, particularly in developing regions of the world. The social and economic consequences of this disease and its complications are enormous. We discuss the scope and implications of the increasing burden of diabetes and describe the rationale and design of a new international study examining blood pressure lowering and glucose control interventions aimed at reducing the risk of vascular complications in people with type 2 diabetes. This study is the first large-scale randomized trial in diabetes to include participants from both lower- and higher-income regions of the world.
Publisher: Japanese Society of Hypertension
Date: 2004
Abstract: Controversy persists as to whether reducing the blood pressure of patients with a history of stroke leads to an increased risk of silent brain infarct (SBI) and dementia. A total of 667 patients were randomized to receive the angiotensin-converting enzyme (ACE) inhibitor perindopril (4 mg daily), with or without the diuretic indapamide (2 mg daily) or matching placebo(s). Brain CT scanning was performed annually over the mean follow-up period of 3.9 years. Active treatment reduced the blood pressure (systolic/diastolic) by 5.2/2.6 mmHg over the follow-up period. A total of 119 new SBI were detected and 92% of them were lacunar type small infarcts. The frequency of reaching the primary end-point (recurrent symptomatic stroke or new SBI) was similar in the placebo group (26.5%) and in the active treatment group (25.9%). There was no significant difference in brain atrophy indices between two groups. In the subgroup with a history of large artery infarction, 7 out of 55 patients from the placebo group developed new SBI, while none of the 40 patients from the active treatment group did so (p = 0.020). The baseline diastolic blood pressure was significantly associated with the risk of new SBI (p = 0.004), but the stroke subtype was not. In conclusion, blood pressure-lowering with a perindopril-based regimen did not increase the risk of SBI and brain atrophy in patients with a history of stroke. The baseline diastolic blood pressure was an independent predictor of new SBI, but the index stroke subtype did not influence the risk of SBI.
Publisher: Elsevier BV
Date: 11-2022
DOI: 10.1093/JN/NXAC152
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2017
DOI: 10.1161/HYPERTENSIONAHA.117.09202
Abstract: There is a critical need for blood pressure–lowering strategies that have greater efficacy and minimal side effects. Low-dose combinations hold promise in this regard, but there are few data on very-low-dose therapy. We, therefore, conducted a systematic review and meta-analysis of randomized controlled trials with at least one quarter-dose and one placebo and standard-dose monotherapy arm. A search was conducted of Medline, Embase, Cochrane Registry, Food and Drug Administration, and European Medicinal Agency websites. Data on blood pressure and adverse events were pooled using a fixed-effect model, and bias was assessed using Cochrane risk of bias. The review included 42 trials involving 20 284 participants. Thirty-six comparisons evaluated quarter-dose with placebo and indicated a blood pressure reduction of −4.7/−2.4 mm Hg ( P .001). Six comparisons were of dual quarter-dose therapy versus placebo, observing a −6.7/ −4.4 mm Hg ( P .001) blood pressure reduction. There were no trials of triple quarter-dose combination versus placebo, but one quadruple quarter-dose study observed a blood pressure reduction of −22.4/−13.1 mm Hg versus placebo ( P .001). Compared with standard-dose monotherapy, the blood pressure differences achieved by single (37 comparisons), dual (7 comparisons), and quadruple (1 trial) quarter-dose combinations were +3.7/+2.6 ( P .001), +1.3/−0.3 (NS), and −13.1/−7.9 ( P .001) mm Hg, respectively. In terms of adverse events, single and dual quarter-dose therapy was not significantly different from placebo and had significantly fewer adverse events compared with standard-dose monotherapy. Quarter-dose combinations could provide improvements in efficacy and tolerability of blood pressure–lowering therapy.
Publisher: Elsevier BV
Date: 02-2016
DOI: 10.1016/J.IJCARD.2015.12.015
Abstract: To conduct a prospective, in idual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk in iduals. Three trials comparing polypill-based care with usual care in in iduals with CVD or high calculated cardiovascular risk contributed IPD. Primary outcomes were self-reported adherence to combination therapy (anti-platelet, statin and ≥ two blood pressure (BP) lowering agents), and difference in mean systolic BP (SBP) and LDL-cholesterol at 12 months. Analyses used random effects models. Among 3140 patients from Australia, England, India, Ireland, New Zealand and The Netherlands (75% male, mean age 62 years), median follow-up was 15 months. At baseline, 84%, 87% and 61% respectively were taking a statin, anti-platelet agent and at least two BP lowering agents. At 12 months, compared to usual care, participants in the polypill arm had higher adherence to combination therapy (80% vs. 50%, RR 1.58 95% CI, 1.32 to 1.90 p < 0.001), lower SBP (-2.5 mmHg 95% CI, -4.5 to -0.4 p = 0.02) and lower LDL-cholesterol (-0.1 mmol/L 95% CI, -0.2 to 0.0 p = 0.04). Baseline treatment levels were a major effect modifier for adherence and SBP (p-homog < 0.0001 and 0.02 respectively) with greatest improvements seen among those under-treated at baseline. Polypill therapy significantly improved adherence, SBP and LDL-cholesterol in high risk patients compared with usual care, especially among those who were under-treated at baseline.
Publisher: Oxford University Press (OUP)
Date: 10-2002
Abstract: To determine the effects on homocysteine levels of two doses of folic acid compared to placebo, where the high dose is typical of that provided by pharmacological intervention and the low dose approximates that provided by dietary supplementation. The PACIFIC study was a double-blind, placebo-controlled, factorial randomized trial. Seven hundred and twenty-three in iduals with a history of myocardial infarction or unstable angina were recruited from 28 clinical cardiology centres in Australia and New Zealand and randomized to folic acid 2.0 mg daily, folic acid 0.2 mg daily or placebo. The primary outcome, homocysteine, was measured using a fluorescence polarization immunoassay. Compared to placebo, 2.0 mg folic acid reduced homo-cysteine by 1.8 micromol x 1(-1) [95% confidence interval (CI) 1.3-2.3] and 0.2 mg reduced homocysteine by 1.2 micromol x 1(-1) [95% CI 0.8-1.7). The higher dose reduced homocysteine significantly more than the lower dose (P=001). Both doses of folic acid reduced homocysteine, but the effects of the 2.0 mg dose were about one third greater than the 0.2 mg dose. Fortification of foods with folic acid should result in population-wide lower levels of homocysteine but high-dose pharmacological supplementation would produce greater reductions for high-risk in iduals.
Publisher: Frontiers Media SA
Date: 08-06-2023
DOI: 10.3389/FPUBH.2023.1182132
Abstract: Dietary sodium has a dose-response relationship with cardiovascular disease, and sodium intake in Sweden exceeds national and international recommendations. Two thirds of dietary sodium intake comes from processed foods, and adults in Sweden eat more processed foods than any other European country. We hypothesized that sodium content in processed foods is higher in Sweden than in other countries. The aim of this study was to investigate sodium content in processed food items in Sweden, and how it differs from Australia, France, Hong Kong, South Africa, the United Kingdom and the United States. Data were collected from retailers by trained research staff using standardized methods. Data were categorized into 10 food categories and compared using Kruskal-Wallis test of ranks. Sodium content in the food items was compared in mg sodium per 100 g of product, based on the nutritional content labels on the packages. Compared to other countries, Sweden had among the highest sodium content in the “dairy” and “convenience foods” categories, but among the lowest in “cereal and grain products,” “seafood and seafood products” and “snack foods” categories. Australia had the overall lowest sodium content, and the US the overall highest. The highest sodium content in most analyzed countries was found in the “meat and meat products” category. The highest median sodium content in any category was found among “sauces, dips, spreads and dressings” in Hong Kong. The sodium content differed substantially between countries in all food categories, although contrary to our hypothesis, processed foods overall had lower sodium content in Sweden than in most other included countries. Sodium content in processed food was nonetheless high also in Sweden, and especially so in increasingly consumed food categories, such as “convenience foods”.
Publisher: Oxford University Press (OUP)
Date: 06-2020
DOI: 10.1093/NDT/GFAA142.P1028
Abstract: Patient with type 2 diabetes mellitus (T2DM) included in trials of sodium-glucose cotransporter 2 inhibitors are heterogeneous in terms of disease severity. We assessed the effects of canagliflozin compared to placebo on cardiovascular and renal outcomes in the CANVAS program according to severity of T2DM as indicated by intensity of treatment, duration of diabetes and glycaemic control. We compared effects on major adverse cardiovascular events ([MACE], defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) according to three indicators of T2DM severity at study baseline: number of oral glucose lowering treatments or insulin therapy (0-1, 2, 3+, insulin), duration of diabetes (& , 10-16, & years) and HbA1c (& .0, 7.0-7.5, 7.5-8.0, 8.0-8.5, 8.5-9, & .0%). We also assessed effects on other pre-specified cardiovascular outcomes, and an adjudicated composite of end-stage kidney disease, renal death or sustained 40% decline in estimated glomerular filtration rate. We assessed for constancy of hazard ratios across subgroups by fitting an interaction term that tested for linear trend. Of 10,142 participants in the CANVAS Program, 1011 experienced a MACE during a mean follow-up of 3.6 years. Event rates for MACE were higher in those with longer duration of diabetes and higher HbA1c at baseline. The effect of canagliflozin on MACE in the overall population (HR 0.86, 95 % CI 0.75-0.97) was consistent irrespective of the number of glucose lowering treatments (p=0.509), duration of diabetes (p=0.174) and baseline HbA1c (p =0.314). Effects were also consistent across different levels of T2DM disease severity for all other outcomes studied. Higher event rates were observed in those with longer disease duration and higher HbA1c. The proportional risk reductions achieved with canagliflozin were comparable regardless of diabetes duration, number of therapies or HbA1C at baseline.
Publisher: Springer Science and Business Media LLC
Date: 20-01-2016
DOI: 10.1038/SREP19596
Abstract: Considerable evidence has associated increasing portion sizes with elevated obesity prevalence. This study examines typical portion sizes of commonly consumed core and discretionary foods in Australian adults and compares these data with the Australian Dietary Guidelines standard serves. Typical portion sizes are defined as the median amount of foods consumed per eating occasion. Sex- and age-specific median portion sizes of adults aged 19 years and over (n = 9341) were analysed using one day 24 hour recall data from the 2011–12 National Nutrition and Physical Activity Survey. A total of 152 food categories were examined. There were significant sex and age differences in typical portion sizes among a large proportion of food categories studied. Typical portion sizes of breads and cereals, meat and chicken cuts and starchy vegetables were 30–160% larger than the standard serves, whereas, the portion sizes of dairy products, some fruits and non-starchy vegetables were 30–90% smaller. Typical portion sizes for discretionary foods such as cakes, ice-cream, sausages, hamburgers, pizza and alcoholic drinks exceeded the standard serves by 40–400%. The findings of the present study are particularly relevant for establishing Australian-specific reference portions for dietary assessment tools, refinement of nutrition labelling and public health policies.
Publisher: Wiley
Date: 14-11-2015
DOI: 10.1111/JCH.12732
Publisher: Massachusetts Medical Society
Date: 17-08-2017
Publisher: Elsevier BV
Date: 07-2022
Publisher: Wiley
Date: 25-07-2020
DOI: 10.1111/JCH.13947
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2009
Publisher: Elsevier BV
Date: 05-2016
Publisher: Public Library of Science (PLoS)
Date: 25-05-2011
Publisher: Springer Science and Business Media LLC
Date: 03-03-2005
DOI: 10.1007/S00125-005-1677-7
Abstract: Asian populations have high risks of disease at low levels of BMI and weight, possibly because of high rates of abdominal obesity. In such populations, waist circumference and WHR (measures of fat distribution) may better capture the effects of adiposity. The strengths of the associations between different measures of adiposity and glucose levels and diabetes were investigated in the Thai component of the International Collaborative Study of Cardiovascular Disease in Asia (InterASIA), a multi-stage cross-sectional survey of risk factors in Thai adults aged 35 years or over. The analyses included 5,302 men and women. All four measures of adiposity were positively associated with plasma glucose and the odds of having diabetes (all p<0.001), but the associations were stronger for measures of fat distribution. The age- and sex-adjusted fasting plasma glucose level increased linearly across each fifth of weight, BMI, waist and WHR by 0.12 mmol/l (SE 0.02), 0.12 (0.02), 0.17 (0.02) and 0.16 (0.02), respectively. The corresponding odds ratios for diabetes were 1.41 (95% CI 1.27-1.56), 1.43 (1.28-1.59), 1.64 (1.47-1.83) and 1.70 (1.52-1.90), respectively. Multivariate analyses incorporating different combinations of adiposity measures, as well as analyses of receiver operating characteristics, confirmed the greater predictive value of measures of fat distribution. Waist circumference and WHR were more strongly associated with fasting plasma glucose and diabetes than were weight and BMI. These measures of abdominal adiposity are likely to be more useful for assessing the obesity-related risk of cardiovascular diseases in Asian populations.
Publisher: Elsevier BV
Date: 2004
Publisher: Oxford University Press (OUP)
Date: 06-2020
DOI: 10.1093/NDT/GFAA142.P1013
Abstract: To describe genital mycotic infections (GMI) and urinary tract infections (UTI) in the CREDENCE trial, determine whether canagliflozin increased the risk of these infections overall and in subgroups, and describe predictors of risk for genital mycotic infections. The CREDENCE trial randomised people with type 2 diabetes and albuminuric stage 2 and 3 chronic kidney disease to canagliflozin 100mg daily or placebo. We analysed the risk of GMI and UTI with canagliflozin compared to placebo overall and in patient subgroups. The primary analysis was conducted in the on-treatment population, as the more conservative approach with sensitivity analyses conducted using an intention-to-treat population. When canagliflozin increased risk, we determined patient risk factors for GMIs using multivariable Cox regression models adjusting for age, gender, race, markers of disease severity (body mass index (BMI), haemoglobin A1c, diabetes duration, other glucose lowering medications at baseline and kidney function). Overall 31/2905 (1.1%) men and 32/1492 (2.1%) women experienced 91 GMIs and 166/2905 (5.7%) men and 300/1492 (20.1%) women experienced 669 UTIs. Canagliflozin increased the risk of GMI (HR 3.83 [95% CI 2.08-7.06] p& .0001). The hazard ratio for canagliflozin compared to placebo was consistent across most subgroups, though the risk with canagliflozin was greater in those with a higher BMI (HR 5.91 [95% CI 2.65-13.15] for BMI ≥30 kg/m2 vs HR 1.36 [95% CI 0.47-3.92] for BMI& kg/m2, p interaction=0.03) and was higher in men (HR 9.30 [95% CI 2.83-30.60] vs HR 2.10 [95% CI 1.00-4.45] for men and women respectively, p interaction=0.04). In those who were randomised to canagliflozin, independent risk factors for GMI were higher BMI (HR 1.53 [95% CI 1.29-1.83] per 5 units p& .0001) and longer diabetes duration (HR 1.18 [95% CI 1.01-1.40] per 5 years p=0.04). Canagliflozin did not affect the risk of UTI over placebo (HR 1.08 [95% CI 0.90-1.29] p=0.42) overall or in any subgroup, however risk was higher in women (HR 1.23 [95% CI 0.98-1.54] vs HR 0.82 [0.60-1.11] for women and men respectively, p interaction=0.04).58/669 (8.7%) UTIs but no GMIs were reported as serious. Drug was continued in 56/63 (89%) of first GMIs, with similar frequency of subsequent GMI in those continuing on canagliflozin (13/43, 30.2%) or placebo (4/13, 30.8%). Drug was continued in 385/466 (82.6%) first UTIs, with similar frequency of subsequent UTIs in those continuing on cangliflozin (50/199 (25.1%) or placebo 49/186 (26.3%). All findings were similar when conducted using an intention-to-treat approach. Canagliflozin increased the risk of genital mycotic infections but not urinary tract infections. The risk of genital mycotic infections from canagliflozin over placebo was higher in men and those with higher BMI. In those treated with canagliflozin, higher BMI and longer diabetes duration independently predicted infection. Most participants continued treatment following their first infection with similar recurrence rates in the canagliflozin and placebo groups.These findings will be useful in clinical care, and help identify those at greatest risk for genital infections with canagliflozin treatment.
Publisher: Elsevier BV
Date: 11-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2012
DOI: 10.1161/CIRCOUTCOMES.112.966168
Abstract: Early trials evaluating the effect of omega 3 fatty acids (ω-3 FA) reported benefits for mortality and cardiovascular events but recent larger studies trials have variable findings. We assessed the effects of ω-3 FA on cardiovascular and other important clinical outcomes. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for all randomized studies using dietary supplements, dietary interventions, or both. The primary outcome was a composite of cardiovascular events (mostly myocardial infarction, stroke, and cardiovascular death). Secondary outcomes were arrhythmia, cerebrovascular events, hemorrhagic stroke, ischemic stroke, coronary revascularization, heart failure, total mortality, nonvascular mortality, and end-stage kidney disease. Twenty studies including 63030 participants were included. There was no overall effect of ω-3 FA on composite cardiovascular events (relative risk [RR]=0.96 95% confidence interval [CI], 0.90–1.03 P =0.24) or on total mortality (RR=0.95 95% CI, 0.86–1.04 P =0.28). ω-3 FA did protect against vascular death (RR=0.86 95% CI, 0.75–0.99 P =0.03) but not coronary events (RR=0.86 95% CI, 0.67–1.11 P =0.24). There was no effect on arrhythmia (RR=0.99 95% CI, 0.85–1.16 P =0.92) or cerebrovascular events (RR=1.03 95% CI, 0.92–1.16 P =0.59). Adverse events were more common in the treatment group than the placebo group (RR=1.18, 95% CI, 1.02–1.37 P =0.03), predominantly because of an excess of gastrointestinal side effects. ω-3 FA may protect against vascular disease, but the evidence is not clear-cut, and any benefits are almost certainly not as great as previously believed.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2023
DOI: 10.1161/HYPERTENSIONAHA.122.20115
Abstract: The SSaSS (Salt Substitute and Stroke Study) recently reported definitive effects of a potassium-enriched salt on cardiovascular outcomes and death. Quantifying the amount of potassium-enriched salt used by trial participants is important for understanding the magnitude of the effect of potassium-enriched salt on risk reduction and how population-wide scale-up might be achieved. Baseline and annual 24-hour urine s les were collected from subgroups of participants in SSaSS throughout the 5-year follow-up. The mean difference in 24-hour potassium excretion between the 2 groups was used to estimate the quantity of potassium-enriched salt consumed in the intervention group. The corresponding projected difference in sodium intake between groups was calculated and compared with the observed difference. The potassium-enriched salt group, compared to the regular salt group, had a mean increase in 24-hour urinary potassium excretion of 0.80 g/d (95% CI, 0.71–0.90), which equates to consumption of 8.8 g/d (95% CI, 7.8–9.9) of potassium-enriched salt. Based on 8.8 g/d potassium-enriched salt consumption, the projected difference in 24-hour urinary sodium excretion was −0.79 g/d. This compares to an observed difference of −0.35 g/d (95% CI, −0.55 to −0.15) and suggests that 72% of baseline regular salt intake was replaced by potassium-enriched salt. The smaller than anticipated between-group difference in sodium excretion likely results from the joint use of regular salt and potassium-enriched salt in the intervention group. Our findings suggest that even an incomplete replacement of regular salt with potassium-enriched salt can deliver significant health gains. URL: www.clinicaltrials.gov Unique identifier: NCT02092090.
Publisher: American Diabetes Association
Date: 25-07-2016
DOI: 10.2337/DC16-0588
Abstract: Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis in type 2 diabetes, but the relationship between other vascular diseases and PAD has been poorly investigated. We examined the impact of previous microvascular and macrovascular disease on the risk of major PAD in patients with type 2 diabetes. We analyzed 10,624 patients with type 2 diabetes free from baseline major PAD in the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) clinical trial. The primary composite outcome was major PAD defined as PAD-induced death, peripheral revascularization, lower-limb utation, or chronic ulceration. The secondary end points were the PAD components considered separately. Major PAD occurred in 620 (5.8%) participants during 5 years of follow-up. Baseline microvascular and macrovascular disease were both associated with subsequent risk of major PAD after adjustment for age, sex, region of origin, and randomized treatments. However, only microvascular disease remained significantly associated with PAD after further adjustment for established risk factors. The highest risk was observed in participants with a history of macroalbuminuria (hazard ratio 1.91 [95% CI 1.38–2.64], P & 0.0001) and retinal photocoagulation therapy (1.60 [1.11–2.32], P = 0.01). Baseline microvascular disease was also associated with a higher risk of chronic lower-limb ulceration (2.07 [1.56–2.75], P & 0.0001) and utation (1.59 [1.15–2.22], P = 0.006), whereas baseline macrovascular disease was associated with a higher rate of angioplasty procedures (1.75 [1.13–2.73], P = 0.01). Microvascular disease, particularly macroalbuminuria and retinal photocoagulation therapy, strongly predicts major PAD in patients with type 2 diabetes, but macrovascular disease does not.
Publisher: Cambridge University Press (CUP)
Date: 29-06-2015
DOI: 10.1017/S0007114515002056
Abstract: Despite tremendous growth in the consumption of gluten-free (GF) foods, there is a lack of evaluation of their nutritional profile and how they compare with non-GF foods. The present study evaluated the nutritional quality of GF and non-GF foods in core food groups, and a wide range of discretionary products in Australian supermarkets. Nutritional information on the Nutrition Information Panel was systematically obtained from all packaged foods at four large supermarkets in Sydney, Australia in 2013. Food products were classified as GF if a GF declaration appeared anywhere on the product packaging, or non-GF if they contained gluten, wheat, rye, triticale, barley, oats or spelt. The primary outcome was the ‘Health Star Rating’ (HSR: lowest score 0·5 optimal score 5), a nutrient profiling scheme endorsed by the Australian Government. Differences in the content of in idual nutrients were explored in secondary analyses. A total of 3213 food products across ten food categories were included. On average, GF plain dry pasta scored nearly 0·5 stars less ( P 0·001) compared with non-GF products however, there were no significant differences in the mean HSR for breads or ready-to-eat breakfast cereals ( P ≥ 0·42 for both). Relative to non-GF foods, GF products had consistently lower average protein content across all the three core food groups, in particular for pasta and breads (52 and 32 % less, P 0·001 for both). A substantial proportion of foods in discretionary categories carried GF labels (e.g. 87 % of processed meats), and the average HSR of GF discretionary foods were not systematically superior to those of non-GF products. The consumption of GF products is unlikely to confer health benefits, unless there is clear evidence of gluten intolerance.
Publisher: Ubiquity Press, Ltd.
Date: 03-2016
Publisher: Springer Science and Business Media LLC
Date: 13-06-2019
DOI: 10.1007/S10903-019-00908-3
Abstract: Illustrated health resources are useful for people who have limited English linguistic ability. The aim was to compare the preferences of resettled refugees from Africa and non-African countries, on pictograms describing common symptoms of illness. Data were collected in two cities in Queensland, Australia. Participants indicated their preference for three types of pictograms depicting seven symptoms. Pictogram sources included the International Pharmaceutical Federation, royalty-free stock images, and pictograms designed in South Africa. For all ailments, participants (n = 81) from Africa preferred the African pictograms more than participants not from Africa (n = 61). A significant association was found between pictogram preference and where respondents were from for each ailment except headache (p = 0.375). African refugees showed a significant preference for pictograms which had been culturally adapted for an African population however, some other refugees also preferred certain African pictograms. Pictograms for resettled refugees should be pre-tested to determine acceptability, as they should be culturally relevant.
Publisher: MDPI AG
Date: 17-09-2021
DOI: 10.3390/NU13093225
Abstract: Widespread use of reduced-sodium salts can potentially lower excessive population-level dietary sodium intake. This study aimed to identify key barriers and facilitators to implementing reduced-sodium salt as a population level intervention. Semi-structured interviews were conducted with key informants from academia, the salt manufacturing industry, and government. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to inform our interview guides and data analysis. Eighteen key informants from nine countries across five World Health Organization regions participated in the study from January 2020 to July 2020. Participants were concerned about the lack of robust evidence on safety for specific populations such as those with renal impairment. Taste and price compared to regular salt and an understanding of the potential health benefits of reduced-sodium salt were identified as critical factors influencing the adoption of reduced-sodium salts. Higher production costs, low profit return, and reduced market demand for reduced-sodium salts were key barriers for industry in implementation. Participants provided recommendations as potential strategies to enhance the uptake. There are presently substantial barriers to the widespread use of reduced-sodium salt but there are also clear opportunities to take actions that would increase uptake.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-02-2020
Publisher: Elsevier BV
Date: 09-2023
Publisher: Elsevier BV
Date: 12-2001
Publisher: BMJ
Date: 10-2014
DOI: 10.1136/BMJOPEN-2014-006629
Abstract: The scientific evidence base in support of salt reduction is strong but the data required to translate these insights into reduced population salt intake are mostly absent. The aim of this research project is to develop the evidence base required to formulate and implement a national salt reduction programme for India. The research will comprise three components: a stakeholder analysis involving government, industry, consumers and civil society organisations a population survey using an age-stratified and sex-stratified random s les drawn from urban (slum and non-slum) and rural areas of North and South India and a systematic quantitative evaluation of the nutritional components of processed and restaurant foods. The stakeholder interviews will be analysed using qualitative methods to summarise the main themes and define the broad range of factors influencing the food environment in India. The population survey will estimate the mean daily salt consumption through the collection of 24 h urine s les with concurrent dietary surveys identifying the main sources of dietary sodium/salt. The survey of foods will record the nutritional composition of the chief elements of food supply. The findings from this research will be synthesised and proposals for a national salt reduction strategy for India will be developed in collaboration with key stakeholders. This study has been approved by the Human Research Ethics Committees of the University of Sydney and the Centre for Chronic Disease Control in New Delhi, and also by the Indian Health Ministry's Screening Committee. The project began fieldwork in February 2014 and will report the main results in 2016. The findings will be targeted primarily at public health policymakers and advocates, but will be disseminated widely through other mechanisms including conference presentations and peer-reviewed publications, as well as to the participating communities.
Publisher: Oxford University Press (OUP)
Date: 26-09-2012
Abstract: Current guidelines recommend that decisions to start preventative therapy for cardiovascular disease (CVD) should be based on absolute risk however, current risk equations are based on single measurements of risk factors. We aimed to assess whether two measurements of blood pressure and lipids improves the prediction of cardiovascular risk compared to one measurement. We used sex-specific Cox proportional hazards models to evaluate the risk of first CVD event in 2385 participants of the Framingham Offspring Study attending both the second and third visits. We estimated the effects on risk prediction of using the average of two measurements of blood pressure, total cholesterol, and HDL cholesterol compared to using one measurement of the risk factors. We found that these risk factors were each markedly more predictive of CVD when the average of two measurements was used rather than one measurement and age was less predictive of CVD. There were small improvements in the overall model fit, discrimination, and calibration. Reclassification also showed small improvements across the risk spectrum (net reclassification information, NRI, for women 3.0%, 95% CI -0.9 to 24.8% NRI for men 4.0%, 95% CI -2.2 to 14.1%) and possibly greater improvements for intermediate-risk in iduals (NRI for women 32.3%, 95% CI -21.9 to 46.8% NRI for men 16.0%, 95% CI -3.3 to 43%). Averaging two measurements of blood pressure and lipids results in marked increases in the predictiveness of these risk factors and smaller improvements in the overall prediction of cardiovascular risk including reclassification.
Publisher: Elsevier BV
Date: 11-2013
Publisher: Springer Science and Business Media LLC
Date: 14-04-2014
Publisher: Elsevier BV
Date: 03-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2023
DOI: 10.1161/HYPERTENSIONAHA.122.20105
Abstract: In 2021, the World Health Organization (WHO) set sodium benchmarks for packaged foods to guide countries in setting feasible and effective sodium reformulation programs. We modeled the dietary and health impact of full compliance with the WHO’s sodium benchmarks in Australia and compared it to the potential impact of Australia’s 2020 sodium reformulation targets. We used nationally representative data on food and sodium intake, sodium levels in packaged foods, and food sales volume to estimate sodium intake pre- and post-implementation of the WHO and Australia’s sodium benchmarks for 24 age-sex groups. Using comparative risk assessment models, we then estimated the potential deaths, incidence, and disability-adjusted life years averted from cardiovascular disease, chronic kidney disease, and stomach cancer based on the reductions in sodium intake. Compliance with the WHO’s sodium benchmarks for packaged foods in Australia could lower mean adult sodium intake by 404 mg/day, corresponding to a 12% reduction. This could prevent about 1770 deaths/year (95% uncertainty interval 1168–2587), corresponding to 3% of all cardiovascular disease, chronic kidney disease, and stomach cancer deaths in Australia, and prevent some 6900 (4603–9513) new cases, and 25 700 (17 655–35 796) disability-adjusted life years/year. Compared with Australian targets, the WHO benchmarks will avert around 3 and a half times more deaths each year (1770 versus 510). Substantially greater health impact could be achieved if the Australian government strengthened its current sodium reformulation program by adopting WHO’s more stringent and comprehensive sodium benchmarks.
Publisher: American Diabetes Association
Date: 10-2003
DOI: 10.2337/DIACARE.26.10.2758
Abstract: OBJECTIVE—The aim of this study was to determine in Thai adults aged ≥35 years the prevalence and management of diabetes and the associations of diabetes with cardiovascular risk factors. RESEARCH DESIGN AND METHODS—The International Collaborative Study of Cardiovascular Disease in Asia was a complex s le survey. Data from a structured questionnaire, brief physical examination, and blood s le were collected from 5,105 in iduals aged ≥35 years (response rate 68%). Population estimates were calculated by applying s ling weights derived from the 2000 Thai census. RESULTS—The estimated national prevalence of diabetes in Thai adults was 9.6% (2.4 million people), which included 4.8% previously diagnosed and 4.8% newly diagnosed. The prevalence of impaired fasting glucose was 5.4% (1.4 million people). Diagnosed diabetes, undiagnosed diabetes, and impaired fasting glucose were associated with greater age, BMI, waist-to-hip ratio, systolic blood pressure, total cholesterol, and serum creatinine levels. The majority of in iduals with diagnosed diabetes had received dietary or other behavioral advice, and 82% were taking oral hypoglycemic therapy. Blood pressure-lowering therapy was provided to 67% of diagnosed diabetic patients with concomitant hypertension. CONCLUSIONS—Diabetes is common in Thailand, but one-half of all cases are undiagnosed. Because diagnosed diabetes is likely to be treated with proven, low-cost, preventive therapies such as glucose lowering and blood pressure lowering, initiatives that increased diagnosis rates would be expected to produce substantial health benefits in Thailand.
Publisher: Wiley
Date: 13-03-2021
DOI: 10.1002/EDM2.247
Abstract: Patients with type 2 diabetes (T2D) are predisposed to derangements in serum Magnesium (Mg), which may have implications for cardiometabolic events and outcomes. In clinical trials, participants with T2D randomized to sodium‐glucose co‐transporter 2 (SGLT2) inhibitors have shown mild to moderate increases in serum Mg from baseline levels. This post hoc analysis assesses the relation between serum Mg with cardiovascular outcomes in 10,140 participants of the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. We evaluated the association of baseline serum Mg with the primary composite end point of death from cardiovascular causes, non‐fatal myocardial infarction, and non‐fatal stroke, and tested whether this association is modified by baseline serum Mg. Using mediation analysis, we determined whether change in serum Mg post‐randomization mediates the beneficial effect of canagliflozin on cardiovascular outcomes. Mean serum Mg levels at baseline were 0.77 ± 0.09 mmol/L in both canagliflozin group and placebo groups. The canagliflozin group experienced an average increase in serum Mg by 0.07 mmol/L (95% CI, 0.065–0.072 mmol/L p .001) for the duration of the trial. We found no association between baseline serum Mg levels and the primary composite end point, and no evidence of effect modification by baseline Mg levels. Change in serum Mg post‐randomization was not a mediator of the effects of canagliflozin on cardiovascular outcomes. In participants of the CANVAS Program, baseline and post‐randomization serum Mg levels are not associated with cardiovascular outcomes.
Publisher: Elsevier BV
Date: 11-2017
Publisher: MDPI AG
Date: 16-12-2015
DOI: 10.3390/NU7125545
Publisher: AMPCo
Date: 29-01-2018
DOI: 10.5694/MJA17.00394
Abstract: Salt reduction is a public health priority because it is a leading contributor to the global burden of disease. As in Australia there is uncertainty about the current level of salt intake, we sought to estimate current levels. Random effects meta-analysis of data from 31 published studies and one unpublished dataset that reported salt or sodium consumption by Australian adults on the basis of 24-hour urine collections or dietary questionnaires. MEDLINE (via Ovid) and EMBASE (to August 2016). Thirty-one published studies and one unpublished dataset (1989-2015 16 836 in iduals) were identified. The mean weighted salt consumption estimated from 24-hour urine collections was 8.70 g/day (95% CI, 8.39-9.02 g/day) after adjusting for non-urinary salt excretion, the best estimate of salt intake in Australia is 9.6 g/day. The mean weighted intake was 10.1 g/day (95% CI, 9.68-10.5 g/day) for men and 7.34 g/day (95% CI, 6.98-7.70 g/day) for women. Mean weighted consumption was 6.49 g/day (95% CI, 5.94-7.03 g/day) when measured with diet diaries, 6.76 g/day (95% CI, 5.48-8.05 g/day) when assessed with food frequency questionnaires, and 6.73 g/day (95% CI, 6.34-7.11) when assessed by dietary recall. Salt intake had not decreased between 1989 and 2015 (R 2 = -0.02 P = 0.36). Salt intake in Australian adults exceeds the WHO-recommended maximum of 5 g/day and does not appear to be declining. Measuring salt intake with methods based on self-reporting can substantially underestimate consumption. The data highlight the need for ongoing action to reduce salt consumption in Australia and robust monitoring of population salt intake.
Publisher: Elsevier BV
Date: 2019
DOI: 10.1016/J.JCHF.2019.08.004
Abstract: The purpose of this study was to explore potential mediators of the effects of canagliflozin on heart failure in the CANVAS Program (CANagliflozin cardioVascular Assessment Study NCT01032629 and CANagliflozin cardioVascular Assessment Study-Renal NCT01989754). Canagliflozin reduced the risk of heart failure among patients with type 2 diabetes in the CANVAS Program. The mechanism of protection is uncertain. The percentages of mediating effects of 19 biomarkers were determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the biomarker of interest. Multivariable analyses were used to assess the joint effects of biomarkers that mediated most strongly in univariable analyses. Early changes after randomization in levels of 3 biomarkers (urinary albumin:creatinine ratio, serum bicarbonate, and serum urate) were identified as mediating the effect of canagliflozin on heart failure. Average post-randomization levels of 14 biomarkers (systolic blood pressure, low-density lipoprotein and high-density lipoprotein cholesterol, total cholesterol, urinary albumin:creatinine ratio, weight, body mass index, gamma glutamyltransferase, hematocrit, hemoglobin concentration, serum albumin, erythrocyte concentration, serum bicarbonate, and serum urate) were identified as significant mediators. In idually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%). In a parsimonious multivariable model, erythrocyte concentration, serum urate, and urinary albumin:creatinine ratio were the 3 biomarkers that maximized cumulative mediation (102%). A erse set of potential mediators of the effect of canagliflozin on heart failure were identified. Some mediating effects were anticipated, whereas others were not. The mediators that were identified support existing and novel hypothesized mechanisms for the prevention of heart failure with sodium glucose cotransporter 2 inhibitors.
Publisher: BMJ
Date: 21-10-2004
Publisher: Cambridge University Press (CUP)
Date: 22-08-2017
DOI: 10.1017/S1368980017001987
Abstract: To estimate the proportion of products meeting Indian government labelling regulations and to examine the Na levels in packaged foods sold in India. Nutritional composition data were collected from the labels of all packaged food products sold at Indian supermarkets in between 2012 and 2014. Proportions of products compliant with the Food Safety Standards Authority of India (FSSAI) regulations and labelled with Na content, and mean Na levels were calculated. Comparisons were made against 2010 data from Hyderabad and against the UK Department of Health (DoH) 2017 Na targets. Eleven large chain retail stores in Delhi and Hyderabad, India. Packaged food products ( n 5686) categorised into fourteen food groups, thirty-three food categories and ninety sub-categories. More packaged food products (43 v . 34 % P ·001) were compliant with FSSAI regulations but less (32 v . 38 % P ·001) reported Na values compared with 2010. Food groups with the highest Na content were sauces and spreads (2217 mg/100 g) and convenience foods (1344 mg/100 g). Mean Na content in 2014 was higher in four food groups compared with 2010 and lower in none ( P ·05). Only 27 % of foods in sub-categories for which there are UK DoH benchmarks had Na levels below the targets. Compliance with nutrient labelling in India is improving but remains low. Many packaged food products have high levels of Na and there is no evidence that Indian packaged foods are becoming less salty.
Publisher: American Medical Association (AMA)
Date: 27-06-2005
DOI: 10.1001/ARCHINTE.165.12.1410
Abstract: Blood pressure (BP) level is a major determinant of cardiovascular morbidity and mortality in in iduals with diabetes mellitus. Several guidelines recommend lower BP goals and specific drug classes for these patients. The overviews reported herein were performed to formally compare the effects on cardiovascular events and death of different BP-lowering regimens in in iduals with and without diabetes. Twenty-seven randomized trials (N = 158 709 participants) that included 33 395 in iduals with diabetes and 125 314 without diabetes contributed to these analyses. For each outcome and each comparison summary, estimates of effect and 95% confidence intervals were calculated for patients with and without diabetes using a random-effects model. The constancy of the effects of each treatment regimen in participants with and without diabetes was examined using chi(2) tests of homogeneity. Total major cardiovascular events were reduced to a comparable extent in in iduals with and without diabetes by regimens based on angiotensin-converting enzyme inhibitors, calcium antagonists, angiotensin receptor blockers, and diuretics/beta-blockers (P > .19 for all by chi(2) test of homogeneity). There was limited evidence that lower BP goals produced larger reductions in total major cardiovascular events in in iduals with vs without diabetes (P = .03 by chi(2) test of homogeneity). These overviews showed that the short- to-medium-term effects on major cardiovascular events of the BP-lowering regimens studied were broadly comparable for patients with and without diabetes. Different effects of regimens on intermediate renal outcomes not evaluated in these overviews may still provide a rationale for using specific drug classes in patients with diabetes.
Publisher: Wiley
Date: 06-2016
DOI: 10.1111/JCH.12835
Publisher: Elsevier BV
Date: 2005
DOI: 10.1016/J.ATHEROSCLEROSIS.2005.04.012
Abstract: The metabolic syndrome has been identified as an increasingly important precursor to cardiovascular diseases in many Asian populations. Our objective was to compare the contribution of component risk factors to the diagnosis of the metabolic syndrome, as defined by the Third report of the National Cholesterol Education Program Expert Panel Adult Treatment Panel (NCEP-ATPIII), in the US and selected Asian populations. Nationally representative survey data from Hong Kong, Taiwan, Thailand and the US were used. Analyses were restricted to men and women aged > or = 35 years. The age-standardized prevalence of the NCEP-ATPIII defined metabolic syndrome was highest in the US (31% in men, 35% in women), and lowest in Taiwan (11% in men, 12% in women). The component risk factors that defined the presence of the metabolic syndrome varied between countries. As expected, abnormal waist circumference was considerably more prevalent among in iduals with the metabolic syndrome in the US (72% in men, 94% in women) compared with their Asian counterparts, but substantial variation was also observed between the Asian populations (13-22% in men, 38-63% in women). Furthermore, the relative contribution of other risk factors to the metabolic syndrome was also substantially different between countries. The NCEP-ATPIII definition identifies a heterogeneous group of in iduals with the metabolic syndrome in different populations.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2003
DOI: 10.1097/00004872-200307000-00014
Abstract: To compare the prevalence, awareness, treatment and control of hypertension in north and south, and urban and rural residents of China. A cross-sectional survey conducted in 2000-2001. A multistage cluster s ling method was used to select a nationally representative s le of 15 540 men and women aged 35-74 years from the general Chinese population. Three blood pressure measurements were obtained by trained observers using a standardized mercury sphygmomanometer. Information on history of hypertension and use of antihypertensive medications was obtained by use of a standard questionnaire. Hypertension was defined as a mean systolic blood pressure >or= 140 mmHg and/or diastolic blood pressure >or= 90 mmHg and/or use of antihypertensive medications. The age-standardized prevalence of hypertension was significantly higher among residents living in north than in south China (33.8 versus 23.3%, P < 0.001), but similar in those living in urban and rural areas (29.0 versus 28.1%, P = 0.3). Average systolic and diastolic blood pressure levels were consistently higher in north than in south residents. Residents in north China had higher percentages of awareness but lower percentages of control compared with their counterparts in south China. Percentages of awareness, treatment and control of hypertension were significantly higher in urban than in rural residents. Our study documents a marked north-south gradient in the prevalence of hypertension in China. The previously reported urban-rural difference in the prevalence of hypertension was not noted, perhaps due to a rapid increase in the prevalence of hypertension in rural China.
Publisher: Oxford University Press (OUP)
Date: 06-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 24-04-2020
Abstract: The CREDENCE randomized trial demonstrated that canagliflozin reduces risk of cardiovascular and renal events in people with type 2 diabetes and substantial albuminuria. The authors analyzed CREDENCE data to assess whether canagliflozin’s benefits are safely preserved in people with reduced eGFR, finding that the relative benefits for renal and cardiovascular outcomes appeared consistent among subgroups with initial eGFR ranging from 30 to ml/min per 1.73 m 2 . Absolute benefit for renal outcomes was greater in subgroups with an initial eGFR of ml/min per 1.73 m 2 . Safety outcomes were generally consistent among eGFR subgroups. Canagliflozin led to an acute eGFR drop, followed by relative stabilization of eGFR loss across subgroups. Canagliflozin’s benefits and safety are apparent across the eGFR range, including among those initiating treatment with eGFR as low as 30 ml/min per 1.73 m 2 . Canagliflozin reduced renal and cardiovascular events in people with type 2 diabetes in the CREDENCE trial. We assessed efficacy and safety of canagliflozin by initial estimated glomerular filtration rate (eGFR). CREDENCE randomly assigned 4401 participants with an eGFR of 30 to ml/min per 1.73 m 2 and substantial albuminuria to canagliflozin 100 mg or placebo. We used Cox proportional hazards regression to analyze effects on renal and cardiovascular efficacy and safety outcomes within screening eGFR subgroups (30 to , 45 to , and 60 to ml/min per 1.73 m 2 ) and linear mixed effects models to analyze the effects on eGFR slope. At screening, 1313 (30%), 1279 (29%), and 1809 (41%) participants had an eGFR of 30 to , 45 to , and 60 to ml/min per 1.73 m 2 , respectively. The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all P interaction .11). Subgroups with lower eGFRs, who were at greater risk, exhibited larger absolute benefits for renal outcomes. Canagliflozin’s lack of effect on serious adverse events, utations, and fractures appeared consistent among eGFR subgroups. In all subgroups, canagliflozin use led to an acute eGFR drop followed by relative stabilization of eGFR loss. Among those with an eGFR of 30 to ml/min per 1.73 m 2 , canagliflozin led to an initial drop of 2.03 ml/min per 1.73 m 2 . Thereafter, decline in eGFR was slower in the canagliflozin versus placebo group (–1.72 versus –4.33 ml/min per 1.73 m 2 between-group difference 2.61 ml/min per 1.73 m 2 ). Canagliflozin safely reduced the risk of renal and cardiovascular events, with consistent results across eGFR subgroups, including the subgroup initiating treatment with an eGFR of 30 to ml/min per 1.73 m 2 . Absolute benefits for renal outcomes were greatest in subgroups with lower eGFR. Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE), NCT02065791.
Publisher: Elsevier BV
Date: 2008
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-05-2021
DOI: 10.1161/CIRCULATIONAHA.120.048740
Abstract: People with type 2 diabetes and chronic kidney disease experience a high burden of hypertension, but the magnitude and consistency of blood pressure (BP) lowering with canagliflozin in this population are uncertain. Whether the effects of canagliflozin on kidney and cardiovascular outcomes vary by baseline BP or BP-lowering therapy is also unknown. The CREDENCE trial (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) randomized people with type 2 diabetes and chronic kidney disease to canagliflozin or placebo. In a post hoc analysis, we investigated the effect of canagliflozin on systolic BP across subgroups defined by baseline systolic BP, number of BP-lowering drug classes, and history of apparent treatment-resistant hypertension (BP ≥130/80 mm Hg while receiving ≥3 classes of BP-lowering drugs, including a diuretic). We also assessed whether effects on clinical outcomes differed across these subgroups. The trial included 4401 participants, of whom 3361 (76.4%) had baseline systolic BP ≥130 mm Hg, and 1371 (31.2%) had resistant hypertension. By week 3, canagliflozin reduced systolic BP by 3.50 mm Hg (95% CI, –4.27 to –2.72), an effect maintained over the duration of the trial, with similar reductions across BP and BP-lowering therapy subgroups (all P interaction ≥0.05). Canagliflozin also reduced the need for initiation of additional BP-lowering agents during the trial (hazard ratio, 0.68 [95% CI, 0.61–0.75]). The effect of canagliflozin on kidney failure, doubling of serum creatinine, or death caused by kidney or cardiovascular disease (hazard ratio, 0.70 [95% CI, 0.59–0.82]) was consistent across BP and BP-lowering therapy subgroups (all P interaction ≥0.35), as were effects on other key kidney, cardiovascular, and safety outcomes. In people with type 2 diabetes and chronic kidney disease, canagliflozin lowers systolic BP across all BP-defined subgroups and reduces the need for additional BP-lowering agents. These findings support use of canagliflozin for end-organ protection and as an adjunct BP-lowering therapy in people with chronic kidney disease. URL: www.clinicaltrials.gov Unique identifier: NCT02065791.
Publisher: Proceedings of the National Academy of Sciences
Date: 18-01-2022
Abstract: A global international initiative, such as the Earth BioGenome Project (EBP), requires both agreement and coordination on standards to ensure that the collective effort generates rapid progress toward its goals. To this end, the EBP initiated five technical standards committees comprising volunteer members from the global genomics scientific community: S le Collection and Processing, Sequencing and Assembly, Annotation, Analysis, and IT and Informatics. The current versions of the resulting standards documents are available on the EBP website, with the recognition that opportunities, technologies, and challenges may improve or change in the future, requiring flexibility for the EBP to meet its goals. Here, we describe some highlights from the proposed standards, and areas where additional challenges will need to be met.
Publisher: American Diabetes Association
Date: 13-04-2020
DOI: 10.2337/DC19-2257
Abstract: Sex differences have been described in diabetes cardiovascular outcome trials (CVOTs). We systematically reviewed for baseline sex differences in cardiovascular (CV) risk factors and CV protection therapy in diabetes CVOTs. Randomized placebo-controlled trials examining the effect of diabetes medications on major adverse cardiovascular events in people ≥18 years of age with type 2 diabetes. Included trials reported baseline sex-specific CV risks and use of CV protection therapy. Two reviewers independently abstracted study data. We included five CVOTs with 46,606 participants. We summarized sex-specific data using mean differences (MDs) and relative risks (RRs) and pooled estimates using random effects meta-analysis. There were fewer women than men in included trials (28.5–35.8% women). Women more often had stroke (RR 1.28 95% CI 1.09, 1.50), heart failure (RR 1.30 95% CI 1.21,1.40), and chronic kidney disease (RR 1.33 95% CI 1.17 1.51). They less often used statins (RR 0.90 95% CI 0.86, 0.93), aspirin (RR 0.82 95% CI 0.71, 0.95), and β-blockers (RR 0.93 95% CI 0.88, 0.97) and had a higher systolic blood pressure (MD 1.66 mmHg 95% CI 0.90, 2.41), LDL cholesterol (MD 0.34 mmol/L 95% CI 0.29, 0.39), and hemoglobin A1c (MD 0.11% 95% CI 0.09, 0.14 [1.2 mmol/mol 1.0, 1.5]) than men. We could not carry out subgroup analyses due to the small number of studies. Our study is not generalizable to low CV risk groups nor to patients in routine care. There were baseline sex disparities in diabetes CVOTs. We suggest efforts to recruit women into trials and promote CV management across the sexes.
Publisher: Cambridge University Press (CUP)
Date: 14-02-2023
DOI: 10.1017/S1368980023000332
Abstract: In 2015, the Victorian Salt Reduction Partnership launched a 4-year multifaceted salt reduction intervention designed to reduce salt intake by 1 g/d in children and adults living in Victoria, Australia. Child-relevant intervention strategies included a consumer awareness c aign targeting parents and food industry engagement seeking to reduce salt levels in processed foods. This study aimed to assess trends in salt intake, dietary sources of salt and discretionary salt use in primary schoolchildren pre- and post-delivery of the intervention. Repeated cross-sectional surveys were completed at baseline (2010–2013) and follow-up (2018–2019). Salt intake was measured via 24-h urinary Na excretion, discretionary salt use behaviours by self-report and sources of salt by 24-h dietary recall. Data were analysed with multivariable-adjusted regression models. Victoria, Australia. Children aged 4–12 years Complete 24-h urine s les were collected from 666 children at baseline and 161 at follow-up. Mean salt intake remained unchanged from baseline (6·0 se 0·1 g/d) to follow-up (6·1 0·4 g/d) ( P = 0·36), and there were no clear differences in the food sources of salt and at both time points approximately 70 % of children exceeded Na intake recommendations. At follow-up, 14 % more parents ( P = 0·001) reported adding salt during cooking, but child use of table salt and inclusion of a saltshaker on the table remained unchanged. These findings show no beneficial effect of the Victorian Salt Reduction Partnership intervention on children’s salt intake. More intensive, sustained and coordinated efforts between state and federal stakeholders are required.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-1995
Publisher: BMJ
Date: 03-10-2013
DOI: 10.1136/BMJ.F5680
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-01-2017
Abstract: The scientific evidence base in support of population‐wide salt reduction is strong, but current high‐quality data about salt intake levels in India are mostly absent. This project sought to estimate daily salt consumption levels in selected communities of Delhi and Haryana in north India and Andhra Pradesh in south India. In this study, 24‐hour urine s les were collected using an age‐ and sex‐stratified s ling strategy in rural, urban, and slum areas. Salt intake estimates were made for the overall population of each region and for major subgroups by weighting the survey data for the populations of Delhi and Haryana, and Andhra Pradesh. Complete 24‐hour urine s les were available for 637 participants from Delhi and Haryana and 758 from Andhra Pradesh (65% and 68% response rates, respectively). Weighted mean population 24‐hour urine excretion of salt was 8.59 g/day (95% CI 7.68–9.51) in Delhi and Haryana and 9.46 g/day (95% CI 9.06–9.85) in Andhra Pradesh ( P =0.097). Estimates inflated to account for the minimum likely nonurinary losses of sodium provided corresponding estimates of daily salt intake of 9.45 g/day (95% CI 8.45–10.46) and 10.41 g/day (95% CI 9.97–10.84), respectively. Salt consumption in India is high, with mean population intake well above the World Health Organization recommended maximum of 5 g/day. A national salt reduction program would likely avert much premature death and disability.
Publisher: Elsevier BV
Date: 02-2021
Publisher: Springer Science and Business Media LLC
Date: 12-12-2022
DOI: 10.1186/S12966-022-01389-8
Abstract: Consumption of ultra-processed foods is associated with increased risk of obesity and non-communicable diseases. Little is known about current patterns of ultra-processed foods intake in Australia. The aim of this study was to examine the amount and type of ultra-processed foods purchased by Australian households in 2019 and determine whether purchases differed by socio-economic status (SES). We also assessed whether purchases of ultra-processed foods changed between 2015 and 2019. We used grocery purchase data from a nationally representative consumer panel in Australia to assess packaged and unpackaged grocery purchases that were brought home between 2015 to 2019. Ultra-processed foods were identified according to the NOVA system, which classifies foods according to the nature, extent and purpose of industrial food processing. Purchases of ultra-processed foods were calculated per capita, using two outcomes: grams/day and percent of total energy. The top food categories contributing to purchases of ultra-processed foods in 2019 were identified, and differences in ultra-processed food purchases by SES (Index of Relative Social Advantage and Disadvantage) were assessed using survey-weighted linear regression. Changes in purchases of ultra-processed foods between 2015 to 2019 were examined overall and by SES using mixed linear models. In 2019, the mean ± SD total grocery purchases made by Australian households was 881.1 ± 511.9 g/d per capita. Of this, 424.2 ± 319.0 g/d per capita was attributable to purchases of ultra-processed foods, which represented 56.4% of total energy purchased. The largest food categories contributing to total energy purchased included mass-produced, packaged breads (8.2% of total energy purchased), chocolate and sweets (5.7%), biscuits and crackers (5.7%) and ice-cream and edible ices (4.3%). In 2019, purchases of ultra-processed foods were significantly higher for the lowest SES households compared to all other SES quintiles ( P 0.001). There were no major changes in purchases of ultra-processed foods overall or by SES over the five-year period. Between 2015 and 2019, ultra-processed foods have consistently made up the majority of groceries purchased by Australians, particularly for the lowest SES households. Policies that reduce ultra-processed food consumption may reduce diet-related health inequalities.
Publisher: Wiley
Date: 14-03-2016
DOI: 10.1111/JCH.12806
Publisher: Elsevier BV
Date: 10-2012
DOI: 10.1016/J.DIABRES.2012.05.002
Abstract: To asses differences in treatment effects of a fixed combination of perindopril-indapamide on major clinical outcomes in patients with type 2 diabetes across subgroups of cardiovascular risk. 11,140 participants with type 2 diabetes, from the ADVANCE trial, were randomized to perindopril-indapamide or matching placebo. The Framingham equation was used to calculate 5-year CVD risk and to ide participants into two risk groups, moderate-high risk ( 25% and/or history of macrovascular disease). Endpoints were macrovascular and microvascular events. The mean age of participants was 66 years (42.5% female). 1000 macrovascular and 916 microvascular events were recorded over follow-up of 4.3 years. Relative treatment effects were similar across risk groups, (all P-values for heterogeneity ≥0.38). Hazard ratios for combined macro- and microvascular events were 0.89 (0.77-1.03) for the moderate-high risk and 0.92 (0.81-1.03) for the very high risk. Absolute treatment effects tended to be greater in the high risk groups although differences were not statistically significant (P>0.05). Relative effects of blood pressure lowering with perindopril-indapamide on cardiovascular outcomes were similar across risk groups whilst absolute effects trended to be greater in the high risk group.
Publisher: Elsevier BV
Date: 2007
DOI: 10.1016/J.CCT.2006.08.011
Abstract: The ADVANCE Retinal Measurements (AdRem) Study is a large intervention study evaluating the effects of target driven intensive glucose control and placebo controlled blood pressure lowering on retinal vascular changes. AdRem is a sub-study of the ADVANCE Study (Action in Diabetes and Vascular disease), a 2x2 factorial randomized controlled trial with an ACE inhibitor-diuretic combination (perindopril-indapamide) and a gliclazide MR-based regimen in patients with type 2 diabetes mellitus. The AdRem study is based on seven-field stereoscopic retinal photographs of both eyes. These are taken within 3 months after randomization in ADVANCE (baseline), at the biennial and at the final visit. The primary outcome is progression of two or more steps in ETDRS classification. Secondary outcomes include progression of retinal vascular lesions and distortion of retinal vascular geometry. Retinal photographs are made on film and digitized at a central laboratory. The AdRem study uses fully digitized quality control and grading. Between August 2002 and January 2004 1978 patients were included in the AdRem study, from 39 centers in 14 countries. Approximately 85% comply with the strict AdRem quality requirements. Publication of the results is expected in early 2008. The AdRem study is designed to provide reliable evidence on the effects of intensive glucose control and blood pressure lowering on both diabetic retinopathy and abnormalities of retinal vasculature in patients with type 2 diabetes mellitus.
Publisher: Springer Science and Business Media LLC
Date: 29-04-2021
DOI: 10.1186/S13059-021-02336-9
Abstract: Modern sequencing technologies should make the assembly of the relatively small mitochondrial genomes an easy undertaking. However, few tools exist that address mitochondrial assembly directly. As part of the Vertebrate Genomes Project (VGP) we develop mitoVGP, a fully automated pipeline for similarity-based identification of mitochondrial reads and de novo assembly of mitochondrial genomes that incorporates both long ( 10 kbp, PacBio or Nanopore) and short (100–300 bp, Illumina) reads. Our pipeline leads to successful complete mitogenome assemblies of 100 vertebrate species of the VGP. We observe that tissue type and library size selection have considerable impact on mitogenome sequencing and assembly. Comparing our assemblies to purportedly complete reference mitogenomes based on short-read sequencing, we identify errors, missing sequences, and incomplete genes in those references, particularly in repetitive regions. Our assemblies also identify novel gene region duplications. The presence of repeats and duplications in over half of the species herein assembled indicates that their occurrence is a principle of mitochondrial structure rather than an exception, shedding new light on mitochondrial genome evolution and organization. Our results indicate that even in the “simple” case of vertebrate mitogenomes the completeness of many currently available reference sequences can be further improved, and caution should be exercised before claiming the complete assembly of a mitogenome, particularly from short reads alone.
Publisher: Cambridge University Press (CUP)
Date: 23-02-2015
DOI: 10.1017/S1368980015000336
Abstract: Fast foods are often energy dense and offered in large serving sizes. Observational data have linked the consumption of fast foods to an increased risk of obesity and related diseases. We surveyed the reported energy, total fat and saturated fat contents, and serving sizes, of fast-food items from five major chains across ten countries, comparing product categories as well as specific food items available in most countries. MRC Human Nutrition Research, Cambridge, UK. Data for 2961 food and drink products were collected, with most from Canada ( n 550) and fewest from the United Arab Emirates ( n 106). There was considerable variability in energy and fat contents of fast foods across countries, reflecting both the portfolio of products and serving size variability. Differences in total energy between countries were particularly noted for chicken dishes (649–1197 kJ/100 g) and sandwiches (552–1050 kJ/100g). When comparing the same product between countries variations were consistently observed in total energy and fat contents (g/100 g) for ex le, extreme variation in McDonald’s Chicken McNuggets with 12 g total fat/100 g in Germany compared with 21·1 g/100 g in New Zealand. These cross-country variations highlight the possibility for further product reformulation in many countries to reduce nutrients of concern and improve the nutritional profiles of fast-food products around the world. Standardisation of serving sizes towards the lower end of the range would also help to reduce the risk of overconsumption.
Publisher: Elsevier BV
Date: 08-2019
Abstract: The Health Star Rating (HSR) is a front-of-pack nutrition labelling system, implemented voluntarily in Australia and New Zealand since 2014. Our aim was to evaluate HSR's performance. We used data from peer-reviewed publications and government-commissioned monitoring and evaluation, websites and communiqués to evaluate HSR's performance between June 2014 and October 2018 using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) framework. Thirty-three peer-reviewed publications, 21 government and three independent reports informed the assessment. Awareness and trust in HSR was increasing, though c aign reach remained low. Consumers liked, could understand and use the HSR logo, though effects on purchasing were largely unknown. The algorithm was the focus of a formal review. HSR was present on 20-28% of products but biased to those that scored better (HSR≥3.0). Necessary stakeholders were mostly engaged. A substantial body of work supports continuation and strengthening of HSR. Reasonable refinements to HSR's star graphic and algorithm, action to initiate mandatory implementation, and strengthened HSR governance present the clearest opportunities for improving public health impact. Implications for public health: Development and implementation of government-led front-of-pack nutrition labelling systems have the potential to improve public health, while engaging a erse set of stakeholders.
Publisher: MDPI AG
Date: 10-08-2018
DOI: 10.3390/NU10081065
Abstract: In Australia, manufacturers can use two government-endorsed approaches to advertise product healthiness: the Health Star Rating (HSR) front-of-pack nutrition labelling system, and health claims. Related, but different, algorithms determine the star rating of a product (the HSR algorithm) and eligibility to display claims (the Nutrient Profiling Scoring Criterion (NPSC) algorithm). The objective of this study was to examine the agreement between the HSR and NPSC algorithms. Food composition information for 41,297 packaged products was extracted from The George Institute’s FoodSwitch database. HSR and the NPSC scores were calculated, and the proportion of products in each HSR category that were eligible to display a health claim under the NPSC was examined. The highest agreement between the HSR scoring algorithm and the NPSC threshold to determine eligibility to display a health claim was at the HSR cut-off of 3.5 stars (k = 0.83). Overall, 97.3% (n = 40,167) of products with star ratings of 3.5 or higher were also eligible to display a health claim, and 94.3% (n = 38,939) of products with star ratings less than 3.5 were ineligible to display a health claim. The food group with greatest ergence was “edible oils”, with 45% products (n = 342) with HSR .5, but 64% (n = 495) eligible to display a claim. Categories with large absolute numbers of products with HSR .5, but eligible to display a claim, were “yoghurts and yoghurt drinks” (335 products, 25.4%) and “soft drinks” (299 products, 29.7%). Categories with a large number of products with HSR ≥3.5, but ineligible to display a claim, were “milk” (260 products, 21.2%) and “nuts and seeds” (173 products, 19.7%). We conclude that there is good agreement between the HSR and the NPSC systems overall, but ergence in some food groups is likely to result in confusion for consumers, particularly where foods with low HSRs are eligible to display a health claim. The alignment of the NPSC and HSR scoring algorithms should be improved.
Publisher: Oxford University Press (OUP)
Date: 25-05-2010
Abstract: In iduals with diabetes and chronic kidney disease (CKD) are at high risk for cardiovascular disease. In these analyses of the ADVANCE trial, we assessed the effects of a fixed combination of perindopril-indapamide on renal and cardiovascular outcomes in patients with type 2 diabetes according to baseline CKD stage. Patients with type 2 diabetes were randomized to perindopril-indapamide (4 mg/1.25 mg) or placebo. Treatment effects on cardiovascular (cardiovascular death, myocardial infarction, or stroke) and renal outcomes were compared in subgroups defined by baseline Kidney Disease Outcome Quality Initiative CKD stage. Homogeneity in treatment effect was tested by adding interaction terms to the relevant Cox models. The study included 10 640 participants with known CKD status, of whom 6125 did not have CKD, 2482 were classified as CKD stage 1 or 2, and 2033 as CKD stage ≥3. The relative treatment effects on major cardiovascular events were similar across all stages of CKD, with no heterogeneity in the magnitude of the effects for any outcome. In contrast, the absolute treatment effects approximately doubled in those with CKD stage ≥3 when compared to those with no CKD. For every 1000 patients with CKD stage ≥3 treated for 5 years, active treatment prevented 12 cardiovascular events when compared with six events per 1000 patients with no CKD. The treatment benefits of a routine administration of a fixed combination of perindopril-indapamide to patients with type 2 diabetes on cardiovascular and renal outcomes, and death, are consistent across all stages of CKD at baseline. Absolute risk reductions are larger in patients with CKD highlighting the importance of blood pressure-lowering in this population.
Publisher: Elsevier BV
Date: 08-2013
Publisher: AMPCo
Date: 02-2014
DOI: 10.5694/MJA13.11240
Abstract: To evaluate whether the Food and Health Dialogue (the Dialogue), established by the Australian Government in 2009, is having an impact on reducing premature death and disability caused by poor diet in Australia. We used information derived from the Dialogue website, media releases, communiqués and e-newsletters to evaluate the Dialogue's achievements from October 2009 to September 2013, using the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework. Data describing the processed foods marketed in Australia were extracted from an existing food composition database. Achievements of the Dialogue (goals, targets, actions and health outcomes). The primary goal of the Dialogue was identified as "raising the nutritional profile of foods" to be achieved "through reformulation, consumer education and portion standardisation". Employing a public-private partnership model, the Dialogue has established a framework for collaboration between government, public health groups and industry. In the first 4 years, targets were set for 11 (8.9%) of a total of 124 possible action areas for food reformulation and portion standardisation. None were yet due to have been achieved. There was no evidence that any education programs had been implemented by the Dialogue. There are no indicators of the extent to which population exposure to target nutrients has changed or whether any positive or negative health impacts have ensued. The Dialogue has highly creditable goals but the mechanism for delivering on them has proved inadequate. Explicit processes and the outcomes to be delivered within defined timelines are required, along with a clear plan for remediation if they are not achieved.
Publisher: Elsevier BV
Date: 08-2014
Publisher: Elsevier BV
Date: 11-2010
Publisher: Springer Science and Business Media LLC
Date: 27-03-2020
Publisher: American Diabetes Association
Date: 06-2020
DOI: 10.2337/DB20-26-OR
Abstract: Background: Canagliflozin (CANA) slows progression of chronic kidney disease (CKD) in people with type 2 diabetes. CANA also induces a reversible acute decline in estimated glomerular filtration rate (eGFR), which is believed to be a hemodynamic effect. Predictors of the initial decline and its association with long-term eGFR trajectories and safety outcomes are unknown. Methods: This post-hoc study of the CREDENCE trial included 4289 patients with type 2 diabetes and CKD who had eGFR measured at both baseline and week 3. Participants were categorized by percentage decline in eGFR at week 3: & %, ≤10% to & %, and ≤0%. Baseline characteristics associated with acute eGFR declines & % were evaluated using logistic regression. Long-term eGFR decline and safety outcomes were estimated in each eGFR decline category by linear mixed effects models and Cox regression after adjustment for laboratory measures and medication use. Results: More participants in the CANA (956 [45%]) versus placebo (PBO) group (450 [21%]) had an acute eGFR decline & % (p& .001). A & % decline occurred infrequently (89 [4%] with CANA and 39 [2%] with PBO p& .001). In the CANA but not in the PBO group, older age (OR CANA 1.17, 95% CI 1.05-1.31 per 10 years) and history of heart failure (OR CANA 0.77, 0.59-0.99) were associated with a higher and lower likelihood of an acute eGFR decline & %, respectively (both p for interaction & .05). Following the initial eGFR change, long-term eGFR trajectories as well as overall safety profiles were similar across eGFR decline categories (all p values & .05). Results were consistent when other decline thresholds (& %) were used and in subgroup analysis by baseline eGFR (30-& , 45-& , and 60-& ml/min/1.73 m2). Conclusions: Although acute eGFR declines & % occurred in nearly half of all patients following initiation of CANA, the benefit of CANA compared with placebo was observed regardless of the acute eGFR decline and safety profiles were similar. M. Oshima: Research Support Self Japan Society for the Promotion of Science Program for Fostering Globally Talented Researchers. M.J. Jardine: Other Relationship Self See Other Relationship field. R. Agarwal: Other Relationship Self AbbVie Inc., Akebia Therapeutics, Amgen, AstraZeneca, Bayer Inc., Bird Rock Bio, Boehringer Ingelheim Pharmaceuticals, Inc., Celgene, Daiichi Sankyo, Eli Lilly and Company, GlaxoSmithKline plc., Ironwood Pharmaceuticals, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, OPKO Health, Inc., Reata, Relypsa, Inc., Sandoz, Sanofi, Takeda Pharmaceutical Company Limited, ZS Pharma. G. Bakris: Consultant Self Alnylam, Merck & Co., Inc., Relypsa, Inc., Teijin Pharma Limited. Other Relationship Self Bayer AG, Novo Nordisk Inc., Vascular Dynamics. C. Cannon: None. D.M. Charytan: Advisory Panel Self Allena Pharmaceuticals, AstraZeneca, Merck & Co., Inc., PLC Medical. Employee Self BAIM Institute. Research Support Self Janssen Pharmaceuticals, Inc. Other Relationship Self Baim, Amgen, Medtronic/Covidien, Zoll, Fresenius, Daiichi Sankyo, Douglas and London, Eli Lilly, Merck, Gilead, and Novo Nordisk. D. de Zeeuw: Advisory Panel Self AbbVie Inc., Bayer AG, Boehringer Ingelheim International GmbH, Fresenius Medical Care, Janssen Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma Corporation. R. Edwards: Employee Self Janssen. T. Greene: Other Relationship Self Janssen, Durect, and Pfizer. A. Levin: Consultant Self Janssen Pharmaceuticals, Inc. Research Support Self AstraZeneca K.K., Boehringer Ingelheim Pharmaceuticals, Inc., Gilead Sciences, Inc. K.W. Mahaffey: Consultant Self Medscape, Mitsubishi, Myokardia, NIH, Novartis, Novo Nordisk, Portola, Radiometer, Regeneron, SmartMedics, Springer Publishing, UCSF. Research Support Self Afferent, Amgen, Apple, Inc, AstraZeneca, Car a Medical, Inc, Daiichi, Ferring, Google (Verily), Johnson & Johnson, Luitpold, Medtronic, Merck, NIH, Novartis, Sanofi, St. Jude, Tenax. B. Neal: Research Support Self Janssen Research & Development, LLC, Merck Schering Plough, Roche Pharma, Servier, Zydus Pharmaceuticals, Inc. Other Relationship Self Abbott, Janssen, Novartis, Pfizer, Roche, and Servier. C.A. Pollock: Advisory Panel Self AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Otsuka Pharmaceutical Co., Ltd., Vifor Pharma Group. Research Support Self Diabetes Australia. Speaker’s Bureau Self AstraZeneca, Cipla Inc., MedErgy, Medscape, Mitsubishi Tanabe Pharma Corporation, Novartis AG, Otsuka Pharmaceutical Co., Ltd., Vifor Pharma Group. Other Relationship Self Amgen, George Institute for Global Health, Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc. N. Rosenthal: None. D.C. Wheeler: Advisory Panel Self Boehringer Ingelheim Pharmaceuticals, Inc., Reata. Consultant Self AstraZeneca, Bayer AG, GlaxoSmithKline, Janssen Pharmaceuticals, Inc. Speaker’s Bureau Self Amgen, Astellas Pharma Inc., Mundipharma International, Napp Pharmaceuticals. H. Zhang: Employee Self Renal Division of Peking University First Hospital. B. Zinman: Advisory Panel Self Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. V. Perkovic: Other Relationship Self See Other Relationship field. H.L. Heerspink: Consultant Self AbbVie Inc., AstraZeneca, Boehringer Ingelheim International GmbH, CSL Behring, Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Mundipharma International, Retrophin, Inc. Janssen Research & Development, LLC
Publisher: Elsevier BV
Date: 12-2021
Publisher: Elsevier BV
Date: 09-2018
Publisher: Cambridge University Press (CUP)
Date: 17-05-2017
DOI: 10.1017/S1368980017000799
Abstract: To update the estimate of mean salt intake for the Australian population made by the Australian Health Survey (AHS). A secondary analysis of the data collected in a cross-sectional survey was conducted. Estimates of salt intake were made in Lithgow using the 24 h diet recall methodology employed by the AHS as well as using 24 h urine collections. The data from the Lithgow s le were age- and sex-weighted, to provide estimates of daily salt intake for the Australian population based upon (i) the diet recall data and (ii) the 24 h urine s les. Lithgow, New South Wales, Australia. In iduals aged ≥20 years residing in Lithgow and listed on the 2009 federal electoral roll. Mean (95 % CI) salt intake estimated from the 24 h diet recalls was 6·4 (6·2, 6·7) g/d for the Lithgow population compared with a corresponding figure of 6·2 g/d for the Australian population derived from the AHS. The corresponding estimate of salt intake for Lithgow adults based upon the 24 h urine collections was 9·0 (8·6, 9·4) g/d. When the age- and sex-specific estimates of salt intake obtained from the 24 h urine collections in the Lithgow s le were weighted using Australian census data, estimated salt intake for the Australian population was 9·0 (8·6, 9·5) g/d. Further adjustment for non-urinary Na excretion made the best estimate of daily salt intake for both Lithgow and Australia about 9·9 g/d. The dietary recall method used by the AHS likely substantially underestimated mean population salt consumption in Australia.
Publisher: Ubiquity Press, Ltd.
Date: 2022
DOI: 10.5334/GH.1172
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 16-08-2022
Abstract: The sodium‐glucose cotransporter 2 inhibitor canagliflozin reduced the risk of first cardiovascular composite events in the CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) trial. In this post hoc analysis, we evaluated the effect of canagliflozin on total (first and recurrent) cardiovascular events. The CREDENCE trial compared canagliflozin or matching placebo in 4401 patients with type 2 diabetes, albuminuria, and estimated glomerular filtration rate of 30 to mL/min per 1.73 m 2 , over a median of 2.6 years. The primary outcome was analyzed as a composite of any cardiovascular event including myocardial infarction, stroke, hospitalization for heart failure, hospitalization for unstable angina, and cardiovascular death. Negative binomial regression models were used to assess the effect of canagliflozin on the net burden of cardiovascular events. During the trial, 634 patients had 883 cardiovascular events, of whom 472 (74%) had just 1 cardiovascular event and 162 (26%) had multiple cardiovascular events. Canagliflozin reduced first cardiovascular events by 26% (hazard ratio, 0.74 [95% CI, 0.63–0.86] P .001) and total cardiovascular events by 29% (incidence rate ratio, 0.71 [95% CI, 0.59–0.86] P .001). The absolute risk difference per 1000 patients treated over 2.5 years was −44 (95% CI, −67 to −21) first cardiovascular events and −73 (95% CI, −114 to −33) total events. Canagliflozin reduced cardiovascular events, with a larger absolute benefit for total cardiovascular than first cardiovascular events. These findings provide further support for the benefit of continuing canagliflozin therapy after an initial event to prevent recurrent cardiovascular events. URL: www.clinicaltrials.gov Unique Identifier: NCT02065791.
Publisher: JMIR Publications Inc.
Date: 17-10-2013
DOI: 10.2196/JMIR.2771
Publisher: Massachusetts Medical Society
Date: 14-08-2014
Publisher: Massachusetts Medical Society
Date: 07-10-2010
Publisher: Elsevier BV
Date: 03-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2010
DOI: 10.1161/HYPERTENSIONAHA.110.153817
Abstract: After starting antihypertensives, blood pressure is monitored for several reasons, including assessment of adherence. We aimed to estimate the accuracy of blood pressure monitoring for detecting early nonadherence. We conducted a secondary analysis of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS), a large randomized trial of blood pressure lowering to reduce the risk of recurrent stroke. We compared change in blood pressure 3 months after randomization in people who had discontinued treatment (nonadherent) with those who stayed on treatment (adherent). We also used an indirect method, assessing whether change in blood pressure discriminated between active (adherent) and placebo (nonadherent) groups. Both methods gave similar results. For the 3433 subjects, the mean (SD) of the change in systolic blood pressure was −15.8 mm Hg (SD 18.7 mm Hg) in the adherent group and −4.2 mm Hg (SD 18.1 mm Hg) in the nonadherent group. After recalibration of the mean change in the nonadherent group to 0 mm Hg and in the adherent group to −11.6 mm Hg, the absence of a fall in systolic blood pressure at 3 months had a sensitivity of 50% and a specificity of 80% for detecting nonadherence (50% of nonadherent patients and 20% of adherent patients had a rise in blood pressure). Discriminatory power was modest over the range of cutoffs (area under the receiver–operator curve 0.67). Monitoring blood pressure is poor at detecting nonadherence to blood pressure–lowering treatment. Further research should look at other methods of assessing adherence.
Publisher: Wiley
Date: 2007
DOI: 10.1002/SMJ.611
Publisher: BMJ
Date: 14-05-2008
Publisher: Oxford University Press (OUP)
Date: 08-07-2005
Abstract: To evaluate the role of plasma lipids in recurrent vascular events, including stroke, among in iduals with established cerebrovascular disease. Plasma total cholesterol, HDL cholesterol, and triglycerides were measured at baseline among in iduals participating in the Perindopril Protection Against Recurrent Stroke (PROGRESS) study, a randomized clinical trial of blood pressure lowering among patients with previous stroke or transient ischaemic attack. A series of nested case-control studies were used to investigate the association between each of these lipid variables and the risk of subsequent haemorrhagic stroke, ischaemic stroke, myocardial infarction (MI), and heart failure. A total of 895 patients were selected as cases (83 haemorrhagic stroke, 472 ischaemic stroke, 206 MI, and 258 heart failure) and each was matched with one to three controls. After adjustment for other major cardiovascular risk factors, none of the lipid variables was associated with the risk of either stroke subtype. There were significant positive and negative associations for total cholesterol and HDL, respectively, with the risk of MI the odds ratio comparing the highest and lowest thirds of each of these lipid variables was 2.00 (95% CI: 1.30-3.09) for total cholesterol and 0.58 (95% CI: 0.37-0.90) for HDL. HDL was inversely associated with the risk of heart failure however, this result was of borderline statistical significance (P=0.05). Lipid variables are associated with the risk of MI, but not recurrent stroke, in patients with established cerebrovascular disease.
Publisher: Public Library of Science (PLoS)
Date: 26-10-2021
DOI: 10.1371/JOURNAL.PMED.1003806
Abstract: The Australian Government recently established sodium targets for packaged foods to encourage voluntary reformulation to reduce population sodium consumption and related diseases. We modeled the health impact of Australia’s sodium reformulation targets and additional likely health gains if more ambitious, yet feasible sodium targets had been adopted instead. Using comparative risk assessment models, we estimated the averted deaths, incidence, and disability-adjusted life years (DALYs) from cardiovascular disease (CVD), chronic kidney disease (CKD) and stomach cancer after implementation of (a) Australia’s sodium targets (overall and by in idual companies) (b) United Kingdom’s targets (that covers more product categories) and (c) an optimistic scenario (sales-weighted 25th percentile sodium content for each food category included in the UK program). We used nationally representative data to estimate pre- and post-intervention sodium intake, and other key data sources from the Global Burden of Disease study. Full compliance with the Australian government’s sodium targets could prevent approximately 510 deaths/year (95% UI, 335 to 757), corresponding to about 1% of CVD, CKD, and stomach cancer deaths, and prevent some 1,920 (1,274 to 2,600) new cases and 7,240 (5,138 to 10,008) DALYs/year attributable to these diseases. Over half (59%) of deaths prevented is attributed to reformulation by 5 market-dominant companies. Compliance with the UK and optimistic scenario could avert approximately an additional 660 (207 to 1,227) and 1,070 (511 to 1,856) deaths/year, respectively, compared to Australia’s targets. The main limitation of this study (like other modeling studies) is that it does not prove that sodium reformulation programs will prevent deaths and disease events rather, it provides the best quantitative estimates and the corresponding uncertainty of the potential effect of the different programs to guide the design of policies. There is significant potential to strengthen Australia’s sodium reformulation targets to improve its health impact. Promoting compliance by market-dominant food companies will be critical to achieving the potential health gains.
Publisher: Massachusetts Medical Society
Date: 25-06-2020
Publisher: Oxford University Press (OUP)
Date: 23-05-2023
Publisher: Oxford University Press (OUP)
Date: 23-08-2021
DOI: 10.1093/EURHEARTJ/EHAB497
Abstract: Hyperkalaemia is a common complication of type 2 diabetes mellitus (T2DM) and limits the optimal use of agents that block the renin–angiotensin–aldosterone system, particularly in patients with chronic kidney disease (CKD). In patients with CKD, sodium‒glucose cotransporter 2 (SGLT2) inhibitors provide cardiorenal protection, but whether they affect the risk of hyperkalaemia remains uncertain. The CREDENCE trial randomized 4401 participants with T2DM and CKD to the SGLT2 inhibitor canagliflozin or matching placebo. In this post hoc analysis using an intention-to-treat approach, we assessed the effect of canagliflozin on a composite outcome of time to either investigator-reported hyperkalaemia or the initiation of potassium binders. We also analysed effects on central laboratory-determined hyper- and hypokalaemia (serum potassium ≥6.0 and & .5 mmol/L, respectively) and change in serum potassium. At baseline, the mean serum potassium in canagliflozin and placebo arms was 4.5 mmol/L 4395 (99.9%) participants were receiving renin–angiotensin system blockade. The incidence of investigator-reported hyperkalaemia or initiation of potassium binders was lower with canagliflozin than with placebo [occurring in 32.7 vs. 41.9 participants per 1000 patient-years hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.64–0.95, P = 0.014]. Canagliflozin similarly reduced the incidence of laboratory-determined hyperkalaemia (HR 0.77, 95% CI 0.61–0.98, P = 0.031), with no effect on the risk of hypokalaemia (HR 0.92, 95% CI 0.71–1.20, P = 0.53). The mean serum potassium over time with canagliflozin was similar to that of placebo. Among patients treated with renin–angiotensin–aldosterone system inhibitors, SGLT2 inhibition with canagliflozin may reduce the risk of hyperkalaemia in people with T2DM and CKD without increasing the risk of hypokalaemia.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2007
Publisher: Elsevier BV
Date: 02-2008
Abstract: We describe the prevalence of stage III and IV chronic kidney disease in Thailand from a representative s le of in iduals aged 35 years and above using a stratified, multistage, cluster-s ling method. Population estimates were calculated by applying s ling weights from the 2000 Thai census. Glomerular filtration rates were estimated from serum creatinine using the Cockroft-Gault and the simplified Modification of Diet in Renal Disease (MDRD) formulae. The prevalence of stage III disease among in iduals aged 35 years and above was estimated to be about 20% using the Cockroft-Gault formula and about 13% from the MDRD formula. Stage IV disease was present in about 0.9 and 0.6% of this population using the respective formulae. The highest prevalence rates were observed in less well-developed rural areas and the lowest in developed urban areas. The prevalence of chronic kidney disease was significantly higher than that reported in in iduals over 40 years old from the United States for both stage III and IV disease and higher than the reported incidence in Taiwan and Australia. This high prevalence of chronic kidney disease in Thailand has obvious implications for the health of its citizens and for the allocation of health-care resources.
Publisher: Cambridge University Press (CUP)
Date: 22-11-2012
DOI: 10.1017/S1368980012004806
Abstract: In 2007 the Australian Division of World Action on Salt and Health (AWASH) launched a c aign to encourage the Australian government to take action to reduce population salt intake. The objective of the present research was to assess the impact of the Drop the Salt! c aign on government policy. A review of government activities related to salt reduction was conducted and an advocacy strategy implemented to increase government action on salt. Advocacy actions were documented and the resulting outcomes identified. An analysis of stakeholder views on the effectiveness of the advocacy strategy was also undertaken. Advocacy activities were coordinated through AWASH at the George Institute for Global Health in Sydney. All relevant State and Federal government statements and actions were reviewed and thirteen stakeholders with known interests or responsibilities regarding dietary salt, including food industry, government and health organisations, were interviewed. Stakeholder analysis affirmed that AWASH influenced the government's agenda on salt reduction and four key outputs were attributed to the c aign: (i) the Food Regulation Standing Committee discussions on salt, (ii) the Food and Health Dialogue salt targets, (iii) National Health and Medical Research Council partnership funding and (iv) the New South Wales Premier's Forum on Fast Foods. While it is not possible to definitively attribute changes in government policy to one organisation, stakeholder research indicated that the AWASH c aign increased the priority of salt reduction on the government's agenda. However, a coordinated government strategy on salt reduction is still required to ensure that the potential health benefits are fully realised.
Publisher: MDPI AG
Date: 05-06-2020
DOI: 10.3390/NU12061692
Abstract: Private-label products, products owned by supermarkets, are a growing area of the food supply. The aim of this study was to assess the effect of an intervention that provided an Australian supermarket (‘intervention supermarket’) with comparative nutrition data to improve the healthiness of their private-label range. Between 2015 and 2016, the intervention supermarket received reports that ranked the nutritional quality of their products against competitors. Changes in the nutrient content (sodium, sugar, saturated fat, energy and Health Star Rating) of products from the intervention supermarket between 2015 and 2018 were compared against changes achieved for three comparators (private-label products from two other supermarkets and branded products). The intervention supermarket achieved a significantly greater reduction in the sodium content of their products relative to all three comparators, which ranged between −104 and −52 mg/100 g (all p 0.05). Conversely, the three comparators each achieved a greater relative reduction in the sugar content of their products by between −3.5 and −1.6 g/100 g (all p 0.05). One of the comparators also had a greater relative reduction in the saturated fat and energy content of their products compared to the intervention supermarket (both p .05). There were negligible differences in the Health Star Rating of products between the intervention supermarket and comparators (all p 0.05). Providing comparative nutrition information to a supermarket may be ineffective in improving the healthiness of their private-label products, likely due to competing factors that play a role in the decision-making process behind product reformulation and product discontinuation/innovation.
Publisher: Public Library of Science (PLoS)
Date: 22-07-2015
Publisher: American Diabetes Association
Date: 14-11-2011
DOI: 10.2337/DC11-0755
Abstract: Participants in ADVANCE were drawn from many countries. We examined whether the effects of intensive glycemic control on major outcomes in ADVANCE differ between participants from Asia, established market economies (EMEs), and eastern Europe. ADVANCE was a clinical trial of 11,140 patients with type 2 diabetes, lasting a median of 5 years. Demographic and clinical characteristics were compared across regions using generalized linear and mixed models. Effects on outcomes of the gliclazide modified release–based intensive glucose control regimen, targeting an HbAlc of ≤6.5%, were compared across regions using Cox proportional hazards models. When differences in baseline variables were allowed for, the risks of primary outcomes (major macrovascular or microvascular disease) were highest in Asia (joint hazard ratio 1.33 [95% CI 1.17–1.50]), whereas macrovascular disease was more common (1.19 [1.00–1.42]) and microvascular disease less common (0.77 [0.62–0.94]) in eastern Europe than in EMEs. Risks of death and cardiovascular death were highest in eastern Europe, and the mean difference in glycosylated hemoglobin between the intensive and standard groups was lowest in EMEs. Despite these and other differences, the effects of intensive glycemic control were not significantly different (P ≥ 0.23) between regions for any outcome, including mortality, vascular end points, and severe hypoglycemic episodes. Irrespective of absolute risk, the effects of intensive glycemic control with the gliclazide MR-based regimen used in ADVANCE were similar across Asia, EMEs, and eastern Europe. This regimen can safely be recommended for patients with type 2 diabetes in all of these regions.
Publisher: Springer Science and Business Media LLC
Date: 07-1999
DOI: 10.1007/S11906-999-0045-2
Abstract: Clear evidence shows that decreasing blood pressure reduces risks for major cardiovascular events in patients with hypertension. However, there is considerable uncertainty about the separate effects of the various classes of blood pressure-lowering agents and the effects of blood pressure lowering in patients at high risk, particularly in the absence of hypertension. Several new randomized controlled trials have been started in the past few years in an effort to address these questions. However, in idually, these studies are unlikely to resolve all current uncertainties. For this reason, systematic overviews and meta-analyses of the major ongoing trials are planned. The overviews will be conducted as a collaboration among the principal investigators of the participating trials and will involve about 270,000 patients and 1.1 million patient-years of follow-up. The combined trial results should provide good statistical power to detect even modest differences in the effects of various treatments on major cardiovascular outcomes.
Publisher: MDPI AG
Date: 09-10-2021
Abstract: Sodium glucose cotransporter 2 (SGLT2) inhibitors are a class of medication with broad cardiovascular benefits in those with type 2 diabetes, chronic kidney disease, and heart failure. These include reductions in major adverse cardiac events and cardiovascular death. The mechanisms that underlie their benefits in atherosclerotic cardiovascular disease (ASCVD) are not well understood, but they extend beyond glucose lowering. This narrative review summarises the ASCVD benefits of SGLT2 inhibitors seen in large human outcome trials, as well as the mechanisms of action explored in rodent and small human studies. Potential pathways include favourable alterations in lipid metabolism, inflammation, and endothelial function. These all require further investigation in large human clinical trials with mechanistic endpoints, to further elucidate the disease modifying benefits of this drug class and those who will benefit most from it.
Publisher: Massachusetts Medical Society
Date: 13-06-2019
Publisher: BMJ
Date: 29-01-2010
Abstract: Coronary heart disease (CHD) risk estimation tools are a simple means of identifying those at high risk in a community and hence a potentially cost-effective strategy for CHD prevention in resource-poor countries. Since India has few local data upon which to develop such a tool de novo, in this study a Framingham risk equation has been recalibrated to estimate CHD risks in a population from rural India and the sensitivity of the method to information resources examined. Recent surveys of this population have found high levels of cardiovascular risk factors, particularly metabolic risk factors and a high proportion of mortality due to cardiovascular diseases. The proportion of a rural Indian population at high risk of CHD using three risk estimation equations was estimated. The first a published version of the Framingham risk equation, the second a recalibrated equation using local mortality surveillance data and local risk factor data, and the third a recalibrated equation using national mortality data and local risk factor data. The mean 10-year probability of CHD for adults >30 years was 10.4% (9.6% to 11.1%) for men and 5.3% (4.9% to 5.7%) for women using the Framingham equation 10.7% (9.9% to 11.5%) for men and 4.2% (3.9% to 4.5%) for women using the local recalibration and 18.9% (17.7% to 20.1%) for men and 8.2% (7.6% to 8.8%) for women using the national recalibration. These findings indicate that in India, equations recalibrated to summary national data are unlikely to be relevant to all regions of India and demonstrate the importance of local data collection to enable development of relevant CHD risk tools.
Publisher: BMJ
Date: 28-06-2018
DOI: 10.1136/HEARTJNL-2018-313108
Abstract: The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy. We conducted an in idual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy. Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0–1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively. Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline.
Publisher: Informa UK Limited
Date: 2006
DOI: 10.1080/08037050601066074
Abstract: ADVANCE is a major international trial assessing the effects of routine compared with more intensive blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes, among high-risk in iduals with type 2 diabetes. We describe the experience of participants receiving active blood pressure lowering therapy during the run-in phase of the study, and the characteristics of participants who withdrew during this phase. All participants potentially eligible for inclusion in ADVANCE underwent 6 weeks of therapy with fixed low-dose perindopril 2 mg and indapamide 0.625 mg combination daily, as part of an active run-in phase of the study. This treatment was provided in addition to the participants' existing therapeutic regimen, including other blood pressure lowering drugs. Of the 12 878 registered participants who entered the run-in phase, 11140 participants were randomized. Only 459 participants (3.6%) withdrew due to suspected intolerance of perindopril-indapamide. The mean blood pressure fell by an average of 8/3 mmHg from 145/81 mmHg (standard deviation 22/11 mmHg) to 137/78 (20/10). Participants who proceeded to randomization were broadly similar to those who withdrew during the run-in phase however, some features suggest that those randomized were a higher risk group overall. A substantial fall in blood pressure was observed following 6 weeks of treatment with a fixed low-dose combination of perindopril-indapamide in a broad range of high-risk in iduals with type 2 diabetes. Good tolerability and safety of the study drug was confirmed during the active run-in phase of the ADVANCE study.
Publisher: WHO Press
Date: 2009
Publisher: Springer Science and Business Media LLC
Date: 2014
Publisher: Oxford University Press (OUP)
Date: 09-2020
DOI: 10.1093/EURPUB/CKAA166.1285
Abstract: Nutrient Profiling Systems (NPSs), including the UK Food Standards Agency NPS and its variants are used to classify foods according to their nutritional composition for nutrition policies. The prospective validity of these NPSs requires however further investigation. The study investigates the associations of the original Food Standards Agency (FSA)-NPS and three variants - the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC), the Health Star Rating (HSR) system NPS and the French NPS (HCSP-NPS) -, which are used as a basis for nutrition policies, with weight status. Dietary indices based on each of the four investigated NPSs applied at the food level were computed at the in idual level to characterize the diet quality of 71,178 French in iduals from the NutriNet-Santé cohort. Associations of these Dietary Indices (DIs) (as tertiles) with weight gain were assessed using multivariable mixed models, and with overweight and obesity risks using multivariable Cox models. For the four NPSs, participants with a lower diet nutritional quality were more likely to have an increase in body mass index over time (median follow-up of 3.14 ± 2.76 years, beta coefficients positive, all p ≤ 0.0001), and an increased risk of overweight (HRT3vs.T1=1.27 [1.17-1.37] for the HCSP-DI, followed by the original FSA-DI with HRT3vs.T1=1.18 [1.09-1.28], the NPSC-DI with HRT3vs.T1=1.14 [1.06-1.24] and the HSR-DI, HRT3vs.T1=1.12 [1.04-1.21]). Whilst differences were small, the HCSP-DI appeared to show significantly greater association with risk of overweight compared to other NPS. Less healthy diets defined using the Food Standards Agency-NPS and related systems were all associated with weight gain and overweight risk. Demonstrating this association with health outcomes is an important indicator of one validity dimension of NPSs and supports their use in public policies for the prevention of diet-related chronic diseases. Nutrient profile models of foods and beverages allow capturing the nutritional quality of diets and are prospectively associated with weight gain and obesity. The French NPS which underpins the front-of-pack Nutri-Score appeared to have a small but significant higher performance.
Publisher: Research Square Platform LLC
Date: 03-08-2023
DOI: 10.21203/RS.3.RS-3047964/V1
Abstract: Background Clinical trials are at the heart of medical research, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. Methods This paper explores factors influencing the times to ethics approval, governance approval and site activation. Broadly, these comprised trial characteristics (disease area and trial phase), site characteristics (public or private ownership, country) and characteristics of the ethics and governance processes (scope guidelines, mutual acceptance requirements and triage of projects by risk). Median times were compared between site initiations that were and were not exposed to each characteristic using non-parametric tests in univariable and multivariable regressions. Results There were data from 150 site activations done across 91sites, 16 trials and 5 countries. The overall median time to activation was 234 days (range 74 to 657), with ethics approval taking a median of 48 days (0 to 369) and governance approval a median of 34 days (0 to 489). Both the univariable and multivariable analyses identified associations of disease area, particularly oncology (p univariable = 0.012, p multivariable = 0.044), use of scope guidelines (p 0.001, p = 0.020) and use of a triage process (p 0.001, 0.043) with shorter median times for governance approval. These characteristics (all p 0.001) plus early trial phase (p = 0.028) were also predictive of shorter median times for ethics approval in univariable analyses, but none remained predictive in multivariable models (all p 0.054). The only factors associated with reduced overall time to site activation in both univariable and multivariable analyses were early trial phase (p 0.001, p = 0.013) and mutual acceptance of ethics approvals (p = 0.031, p = 0.030). Interpretation Times to ethics and governance approvals were only one third of total trial start-up time. Factors influencing times to approval and activation were somewhat inconsistent across analyses, but it seems likely that the introduction of selected governance and ethics processes can reduce approval times.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-07-2005
DOI: 10.1161/CIRCULATIONAHA.104.525527
Abstract: Background— B-type natriuretic peptide (BNP), C-reactive protein (CRP), and renin are elevated in persons at risk for cardiovascular disease. However, data that directly compare these markers in the prediction of myocardial infarction (MI) are limited. Methods and Results— N-terminal-proBNP (NT-proBNP), CRP, and renin were measured in baseline blood s les from a nested case-control study of the 6105 participants of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS), a placebo-controlled study of a perindopril-based blood pressure-lowering regimen among in iduals with previous stroke or transient ischemic attack. Each of 206 subjects who experienced MI, either fatal or nonfatal, during a mean follow-up of 3.9 years was matched to 1 to 3 control subjects. Most MI cases (67%) occurred in subjects without a history of coronary heart disease. NT-proBNP, CRP, and renin each predicted MI the odds ratio for subjects in the highest compared with the lowest quarter was 2.2 (95% CI, 1.3 to 3.6) for NT-proBNP, 2.2 (95% CI, 1.3 to 3.6) for CRP, and 1.7 (95% CI, 1.1 to 2.8) for renin. NT-proBNP and renin, but not CRP, remained predictors of MI after adjustment for all other predictors, including LDL and HDL cholesterol levels. In iduals with both NT-proBNP and renin in their highest quarters had 4.5 times the risk of MI compared with subjects with both biological markers in their lowest quarters. Conclusions— NT-proBNP and renin, but not CRP, are independent predictors of MI risk after stroke or transient ischemic attack, providing information additional to that provided by classic risk factors, and may enable more effective targeting of MI prevention strategies.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2022
DOI: 10.2215/CJN.08780621
Abstract: Clinical trials in nephrology are enriched for patients with micro- or macroalbuminuria to enroll patients at risk of kidney failure. However, patients with normoalbuminuria can also progress to kidney failure. TNF receptor-1, TNF receptor-2, and kidney injury marker-1 (KIM-1) are known to be associated with kidney disease progression in patients with micro- or macroalbuminuria. We assessed the value of TNF receptor-1, TNF receptor-2, and KIM-1 as prognostic biomarkers for CKD progression in patients with type 2 diabetes and normoalbuminuria. TNF receptor-1, TNF receptor-2, and KIM-1 were measured using immunoassays in plasma s les from patients with type 2 diabetes at high cardiovascular risk participating in the Canagliflozin Cardiovascular Assessment Study trial. We used multivariable adjusted Cox proportional hazards analyses to estimate hazard ratios per doubling of each biomarker for the kidney outcome, stratified the population by the fourth quartile of each biomarker distribution, and assessed the number of events and event rates. In patients with normoalbuminuria ( n =2553), 51 kidney outcomes were recorded during a median follow-up of 6.1 (interquartile range, 5.8–6.4) years (event rate, 3.5 95% confidence interval, 2.6 to 4.6 per 1000 patient-years). Each doubling of baseline TNF receptor-1 (hazard ratio, 4.2 95% confidence interval, 1.8 to 9.6) and TNF receptor-2 (hazard ratio, 2.3 95% confidence interval, 1.5 to 3.6) was associated with a higher risk for the kidney outcome. Baseline KIM-1, urinary albumin-creatinine ratio, and eGFR were not associated with kidney outcomes. The event rates in the highest quartile of TNF receptor-1 (≥2992 ng/ml) and TNF receptor-2 (≥11,394 ng/ml) were 5.6 and 7.0 events per 1000 patient-years, respectively, compared with 2.8 and 2.3, respectively, in the lower three quartiles. TNF receptor-1 and TNF receptor-2 are associated with kidney outcomes in patients with type 2 diabetes and normoalbuminuria. CANagliflozin cardioVascular Assessment Study (CANVAS), NCT01032629
Publisher: Elsevier BV
Date: 03-2009
Publisher: Elsevier BV
Date: 12-2010
DOI: 10.1016/J.APPET.2010.08.015
Abstract: With more consumers purchasing meals outside the home, fast food products contribute substantially to daily energy intakes. Improving the nutrient composition of fast food would have significant health benefits. Nutrient content data for menu items provided by nine companies representing >90% of the fast food market in Australia were collected. Mean nutrient levels were compared between product categories and compared to currently accepted criteria for healthy foods. The majority of fast food products did not meet criteria for healthy options. Breakfast items had the highest mean sugar content (7.8 g/100 g) and saturated fat (5.5 g/100 g), and chicken items the highest total fat (13.2 g/100 g) and sodium (586 mg/100 g). There was marked variation in nutrient levels between similar products. There was a 10-fold variation in the total fat, saturated fat and sugar content of sandwiches, an 8-fold variation in saturated fat in burgers and >20-fold variation in the sugar and total fat content of salads. Differences were even greater per serve. The considerable variation in the nutrient content of comparable products suggests significant potential for reformulation. Even small improvements in composition could produce important health gains if implemented across all product categories by all companies in unison.
Publisher: Elsevier BV
Date: 06-2019
Publisher: Massachusetts Medical Society
Date: 23-12-2021
DOI: 10.1056/NEJMC2116824
Publisher: Elsevier BV
Date: 11-2020
Publisher: John Wiley & Sons, Ltd
Date: 24-07-2000
Publisher: BMJ
Date: 15-03-2012
DOI: 10.1136/BMJ.E2021
Publisher: MDPI AG
Date: 18-04-2018
DOI: 10.3390/NU10040501
Publisher: Springer Science and Business Media LLC
Date: 11-08-2016
Publisher: SAGE Publications
Date: 21-12-2021
DOI: 10.1177/02601060211039124
Abstract: Background: Vulnerable populations are the most prone to diet-related disease. The availability, healthiness, and price of foods have established associations with diet-related disease in communities. However, data describing this in India are sparse, particularly in urban slums and rural areas. Aim: To quantify and compare availability, healthiness, and price of packaged and unpackaged foods and beverages in India, and to identify opportunities to improve diets and health of vulnerable populations. Methods: Nutrition data and price were collected on foods and beverages available at 44 stores in urban, urban slum, and rural areas in four states in India between May and August 2018. Healthiness was assessed using the Australasian Health Star Rating system and product retail prices were examined. Comparisons in the findings were made across state, community area type, and adherence to current and draft Indian food labeling regulations. Results: Packaged foods and beverages ( n = 1443, 89%) were more prevalent than unpackaged ( n = 172, 11%). Unpackaged products were healthier than packaged (mean Health Star Rating = 3.5 vs 2.0 p 0.001) and lower in price (median price per 100 g/ml: 13.42 Indian rupees vs 25.70 Indian rupees p 0.001), a pattern observed across most community area types and states. 96% of packaged products were compliant with current Indian labeling regulations but only 23% were compliant with proposed labeling regulations. Conclusions: Unpackaged products were on average much healthier and lower in price than packaged foods and beverages. Food policies that support greater availability, accessibility and consumption of unpackaged foods, while limiting consumption of packaged foods, have enormous potential for sustaining the health of the Indian population.
Publisher: Elsevier BV
Date: 05-2017
DOI: 10.1016/J.DIABRES.2017.03.015
Abstract: The relationship between educational level and the risk of all-cause mortality is well established, whereas the association with vascular events in in iduals with type 2 diabetes is not well described. Any association may reflect a link with common cardiovascular or lifestyle-based risk factors. The relationships between the highest level of educational attainment and major cardiovascular events, microvascular complications and all-cause mortality were explored in a cohort of 11,140 in iduals with type 2 diabetes. Completion of formal education before the age of 16 was categorized as a low level of education. Regional differences between Asia, East Europe and Established Market Economies were also assessed. During a median of 5years of follow up, 1031 (9%) patients died, 1147 (10%) experienced a major cardiovascular event and 1136 (10%) a microvascular event. After adjustment for baseline characteristics and risk factors, in iduals with lower education had an increased risk of cardiovascular events (hazard ratio (HR) 1.31, 95% CI 1.16-1.48, p<0.0001), microvascular events (HR 1.23, 95% CI 1.08-1.39, p=0.0013) and all-cause mortality (HR 1.34, 95% CI 1.18-1.52, p<0.0001). In regional analyses the increased risk of studied outcomes associated with lower education was weakest in Established Market Economies and strongest in East Europe. A low level of education is associated with an increased risk of vascular events and death in patients with type 2 diabetes, independently of common lifestyle associated cardiovascular risk factors. The effect size varies between geographical regions.
Publisher: JMIR Publications Inc.
Date: 13-01-2020
Abstract: hildhood obesity is a major public health issue. The increase in the consumption of foods with poor nutritional value, such as processed foods, contributes to this. Breakfast cereals are often advertised as a healthy way to start the day, but the healthiness of these products varies greatly. ur main objective was to gather information about the nutritional characteristics of ready-to-eat breakfast cereals in Sweden and to investigate the healthiness of products targeted at children compared to other cereals by use of the FoodSwitch platform. A secondary objective was to evaluate the alignment between the Keyhole symbol and the Health Star Rating. he FoodSwitch app is a mobile health (mHealth) tool used to present nutrition data and healthier alternative products to consumers. Ready-to-eat breakfast cereals from the largest Swedish grocery retailers were collected using the FoodSwitch platform. Products were defined as targeting children if they presented features addressing children on the package. verall, information on 261 ready-to-eat cereals was examined. Of this total, 8% (n=21) were targeted at children. Child-targeted cereals were higher in sugar (22.3 g/100 g vs 12.8 g/100 g, i P /i & .001) and lower in fiber (6.2 g/100 g vs 9.8 g/100 g, i P /i & .001) and protein (8.1 g/100 g vs 10.5 g/100 g, i P /i & .001). Total fat (3 g/100 g vs 10.5 g/100 g, i P /i & .001) and saturated fat (0.8 g/100 g vs 2.6 g/100 g, i P /i & .001) were also lower. No difference was found in salt content ( i P /i =.61). Fewer child-targeted breakfast cereals displayed an on-pack Keyhole label (n=1, 5% vs n=53, 22% i P /i =.06), and the mean Health Star Rating value was 3.5 for child-targeted cereals compared to others (mean 3.8, i P /i =.07). A correlation was found between the Keyhole symbol and the Health Star Rating. eady-to-eat breakfast cereals targeted at children were less healthy in terms of sugar and fiber content compared to products not targeted at children. There is a need to improve the nutritional quality of child-targeted cereals.
Publisher: Public Library of Science (PLoS)
Date: 13-01-2023
DOI: 10.1371/JOURNAL.PONE.0280226
Abstract: To reduce excess dietary sodium consumption, Nigeria’s 2019 National Multi-sectoral Action Plan (NMSAP) for the Prevention and Control of Non-communicable Diseases includes policies based on the World Health Organization SHAKE package. Priority actions and strategies include mandatory sodium limits in processed foods, advertising restrictions, mass-media c aigns, school-based interventions, and improved front-of-package labeling. We conducted a formative qualitative evaluation of stakeholders’ knowledge, and potential barriers as well as effective strategies to implement these NMSAP priority actions. From January 2021 to February 2021, key informant interviews (n = 23) and focus group discussions (n = 5) were conducted with regulators, food producers, consumers, food retailers and restaurant managers, academia, and healthcare workers in Nigeria. Building on RE-AIM and the Consolidated Framework for Implementation Research, we conducted directed content qualitative analysis to identify anticipated implementation outcomes, barriers, and facilitators to implementation of the NMSAP sodium reduction priority actions. Most stakeholders reported high appropriateness of the NMSAP because excess dietary sodium consumption is common in Nigeria and associated with high hypertension prevalence. Participants identified multiple barriers to adoption and acceptability of implementing the priority actions (e.g., poor population knowledge on the impact of excess salt intake on health, potential profit loss, resistance to change in taste) as well as facilitators to implementation (e.g., learning from favorable existing smoking reduction and advertising strategies). Key strategies to strengthen NMSAP implementation included consumer education, mandatory and improved front-of-package labeling, legislative initiatives to establish maximum sodium content limits in foods and ingredients, strengthening regulation and enforcement of food advertising restrictions, and integrating nutrition education into school curriculum. We found that implementation and scale-up of the Nigeria NMSAP priority actions are feasible and will require several implementation strategies ranging from community-focused education to strengthening current and planned regulation and enforcement, and improvement of front-of-package labeling quality, consistency, and use.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2014
DOI: 10.2215/CJN.10371013
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-07-2023
Abstract: Sodium glucose cotransporter‐2 inhibitors reduce systolic blood pressure (SBP), but whether they affect SBP variability is unknown. There also remains uncertainty regarding the prognostic value of SBP variability for different clinical outcomes. Using in idual participant data from the CANVAS (Canagliflozin Cardiovascular Assessment Study) Program and CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial, we assessed the effect of canagliflozin on SBP variability in people with type 2 diabetes across 4 study visits over 1.5 years as measured by standard deviation, coefficient of variation, and variability independent of the mean. We used multivariable Cox regression models to estimate associations of SBP variability with cardiovascular, kidney, and mortality outcomes. In 11 551 trial participants, canagliflozin modestly lowered the standard deviation of SBP variability (−0.25 mm Hg [95% CI, –0.44 to −0.06]), but there was no effect on coefficient of variation (0.02% [95% CI, –0.12 to 0.16]) or variability independent of the mean (0.08 U [95% CI, –0.11 to 0.26]) when adjusting for correlation with mean SBP. Each 1 standard deviation increase in standard deviation of SBP variability was independently associated with higher risk of hospitalization for heart failure (hazard ratio [HR], 1.19 [95% CI, 1.02–1.38]) and all‐cause mortality (HR, 1.12 [95% CI, 1.01–1.25]), with consistent results observed for coefficient of variation and variability independent of the mean. Increases in SBP variability were not associated with kidney outcomes. In people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease, higher visit‐to‐visit SBP variability is independently associated with risks of hospitalization for heart failure and all‐cause mortality. Canagliflozin has little to no effect on SBP variability, independent of its established SBP‐lowering effect. URL: www.clinicaltrials.gov Unique identifiers: NCT01032629, NCT01989754, NCT02065791.
Publisher: AMPCo
Date: 04-2014
DOI: 10.5694/MJA13.10049
Abstract: OBJECTIVE To define the changes in sodium levels of Australian fast foods between 2009 and 2012 overall, in major food subcategories and by company. A comparison of mean sodium content was made across 4 years using t tests and mixed models. Nutrient content data for fast-food menu items collected from company websites of six large Australian fast-food chains. Mean sodium values in mg/100 g and mg/serve. There were between 302 and 381 products identified each year. Overall, the mean sodium content of fast-food products decreased between 2009 and 2012 by 43 mg/100 g (95% CI, - 66 to - 20 mg/100 g), from 514 mg/100 g in 2009 to 471 mg/100 g in 2012. Mean sodium content per serving was not significantly different at 654 mg in 2009 and 605 mg in 2012 (- 49 mg 95% CI, - 108 to + 10 mg), reflecting wide variation in the serving sizes of items offered each year. There was a small decline in sodium content over the 4 years across most food categories and food companies. The observed reduction in the sodium content of fast foods during the 4-year study period is encouraging. However, the reductions are small, and fast-food companies should be encouraged to make further and larger reductions since many products still contain high levels of sodium.
Publisher: Oxford University Press (OUP)
Date: 04-10-2011
Abstract: Chronic diseases are the leading cause of premature death and disability in the world with overnutrition a primary cause of diet-related ill health. Excess energy intake, saturated fat, sugar, and salt derived from processed foods are a major cause of disease burden. Our objective is to compare the nutritional composition of processed foods between countries, between food companies, and over time. Surveys of processed foods will be done in each participating country using a standardized methodology. Information on the nutrient composition for each product will be sought either through direct chemical analysis, from the product label, or from the manufacturer. Foods will be categorized into 14 groups and 45 categories for the primary analyses which will compare mean levels of nutrients at baseline and over time. Initial commitments to collaboration have been obtained from 21 countries. This collaborative approach to the collation and sharing of data will enable objective and transparent tracking of processed food composition around the world. The information collected will support government and food industry efforts to improve the nutrient composition of processed foods around the world.
Publisher: MDPI AG
Date: 06-09-2017
DOI: 10.3390/NU9090983
Publisher: Springer Science and Business Media LLC
Date: 12-05-2014
Publisher: Cambridge University Press (CUP)
Date: 28-09-2016
DOI: 10.1017/S1368980015002748
Abstract: To compare two front-of-pack nutrition labelling systems for the assessment of packaged foods and drinks with Australian Dietary Guidelines. A cross-sectional nutrient profiling assessment. Food and drink products ( n 20 225) were categorised into scoring levels using criteria for the Institute of Medicine (IOM) three-star system and the five-star Australian Health Star Rating (HSR). The effectiveness of these systems to categorise foods in accordance with Australian Dietary Guidelines was explored. The study was conducted in Australia, using a comprehensive food database. Packaged food and drink products ( n 20 225) available in Australia. Using the IOM three-star system, the majority (55 %) of products scored the minimum 0 points and 25·5 % scored the maximum 3 points. Using HSR criteria, the greatest proportion of products (15·2 %) scored three-and-a-half stars from a possible five and 12·5 % received the lowest rating of a half-star. Very few products (4·1 %) scored five stars. Products considered core foods and drinks in Australian Dietary Guidelines received higher scores than discretionary foods in all food categories for both labelling systems (all P ·05 Mann–Whitney U test), with the exception of fish products using IOM three-star criteria ( P =0·603). The largest discrepancies in median score between the two systems were for the food categories edible oils, convenience foods and dairy. Both the IOM three-star and Australian HSR front-of-pack labelling systems rated packaged foods and drinks broadly in line with Australian Dietary Guidelines by assigning core foods higher ratings and discretionary foods lower ratings.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2010
Publisher: Oxford University Press (OUP)
Date: 23-08-2023
DOI: 10.1093/EURHEARTJ/EHAD535
Abstract: Effervescent formulations of paracetamol containing sodium bicarbonate have been reported to associate with increased blood pressure and a higher risk of cardiovascular diseases and all-cause mortality. Given the major implications of these findings, the reported associations were re-examined. Using linked electronic health records data, a cohort of 475 442 UK in iduals with at least one prescription of paracetamol, aged between 60 and 90 years, was identified. Outcomes in patients taking sodium-based paracetamol were compared with those taking non–sodium-based formulations of the same. Using a deep learning approach, associations with systolic blood pressure (SBP), major cardiovascular events (myocardial infarction, heart failure, and stroke), and all-cause mortality within 1 year after baseline were investigated. A total of 460 980 and 14 462 patients were identified for the non–sodium-based and sodium-based paracetamol exposure groups, respectively (mean age: 74 years 64% women). Analysis revealed no difference in SBP [mean difference −0.04 mmHg (95% confidence interval −0.51, 0.43)] and no association with major cardiovascular events [relative risk (RR) 1.03 (0.91, 1.16)]. Sodium-based paracetamol showed a positive association with all-cause mortality [RR 1.46 (1.40, 1.52)]. However, after further accounting of other sources of residual confounding, the observed association attenuated towards the null [RR 1.08 (1.01, 1.16)]. Exploratory analyses revealed dysphagia and related conditions as major sources of uncontrolled confounding by indication for this association. This study does not support previous suggestions of increased SBP and an elevated risk of cardiovascular events from short-term use of sodium bicarbonate paracetamol in routine clinical practice.
Publisher: Wiley
Date: 30-09-2019
DOI: 10.1111/DOM.13876
Abstract: Sodium-glucose co-transporter-2 (SGLT2) inhibitors prevent cardiovascular complications in type 2 diabetes. We aimed to study whether they have similar effects in women and men by summarizing the effects of SGLT2 inhibitors compared to placebo on vascular and safety outcomes stratified by sex. We included patients with type 2 diabetes enrolled in the EMPA-REG OUTCOME, CANVAS Program, DECLARE TIMI-58 and CREDENCE trials. There were no differences in the risk ratios between men and women, SGLT2 versus control (placebo), for vascular efficacy outcomes or death (all P for interaction ≥.12), with clear protection shown against major adverse cardiovascular events, heart failure, vascular death and total mortality. SGLT2 inhibitor treatment was also associated with similar relative risks in women and men for the safety outcomes of utation, fracture, genital infection and urinary tract infection (all P for interaction ≥.17). SGLT2 inhibition provided similar protection against vascular risks and death, and similar risks of serious adverse events, for women and men.
Publisher: Elsevier BV
Date: 2007
DOI: 10.1016/J.CCT.2006.06.004
Abstract: Timely participant recruitment remains a significant challenge for most clinical trials. We evaluated the effects on participant recruitment of communication between the central trial coordinators and the clinical sites in the setting of a large international multi-centre clinical trial. The effects of communication were determined in a single-blind randomised controlled trial involving 167 clinical sites in 19 countries. Clinical sites were randomised to either additional or usual communication strategies - the additional communication group received a communication package based on additional, in idually-tailored feedback about recruitment, in addition to the usual correspondence from the central trial coordinators that was provided to the control group. The two study outcomes were the median time to half randomisation target and the median total number of participants randomised per clinical site. Eighty-five clinical centres were randomised to receive additional communication and 82 to receive usual communication. At the conclusion of recruitment, there was no significant difference in the median number of participants randomised per centre between the additional and usual groups (37.5 vs. 37.0, p=0.68). The median time to half randomisation target was lower in the additional communication group compared to the usual group, however this difference did not achieve conventional levels of statistical significance (4.4 months vs. 5.8 months, p=0.08). The findings suggest that the additional communication strategy may be of some incremental benefit in helping sites achieve recruitment targets sooner.
Publisher: Oxford University Press (OUP)
Date: 06-2003
DOI: 10.1093/IJE/DYG105
Abstract: Vascular mortality is increasing in economically developing countries such as Thailand but reliable data about the determinants of these changes are few. In 1985, male and female employees of the Electricity Generating Authority of Thailand took part in a cardiovascular risk factor survey. In 1997, a follow-up survey was conducted and causes of death were determined for those subjects known to have died. Changes in levels of vascular risk factors over 12 years, and the associations of baseline risk factors with vascular mortality, were calculated. The 1985 survey recruited 3499 volunteers (average age 43 years) of whom 23% were female. In 1997, vital status was determined for 3318 (95%) and 2967 (85%) of the study participants were resurveyed. Mean levels of systolic blood pressure (SBP) and diastolic blood pressure (DBP), body mass index, total cholesterol and high density lipoprotein (HDL) cholesterol all increased over the 12-year follow-up period. Over the same time, the prevalence of diabetes also rose but the proportion of current smokers decreased. Vascular diseases were the most frequent cause of death during follow-up (n = 46), were positively associated with baseline age, SBP, DBP, smoking, diabetes, male sex, and total cholesterol, and were negatively associated with HDL cholesterol. Levels of most vascular risk factors worsened over the 12-year period between 1985 and 1997. The associations between baseline risk factor levels and vascular mortality were consistent with those observed in other populations. Interventions that control vascular risk factors have the potential to avert much premature vascular disease in Thailand.
Publisher: Oxford University Press (OUP)
Date: 16-02-2012
DOI: 10.1093/IJE/DYR226
Abstract: To investigate the prevalence, screening and knowledge of cardiovascular risk factors (CVRFs) by socio-economic position (SEP) in rural India. An age- and sex-stratified random s le of 4535 adults was recruited from rural Andhra Pradesh and a questionnaire was administered to assess prevalence, screening and knowledge of CVRFs and record recent attempts to modify behaviour. Education, income and occupation were used to measure SEP. Lower fruit intake and higher tobacco and alcohol use were found in those with lower SEP. Overweight, physical inactivity, diabetes, hypertension, family history of cardiovascular disease (CVD) and previous CVD (men only) were greater in higher SEP participants. Lower SEP participants had less blood pressure, glucose or cholesterol screening and less knowledge of nine CVRFs. Regardless of SEP, participants knowledgeable of the harms of a CVRF were more likely to have attempted to modify behaviour. For ex le, knowledge of benefits of smoking cessation was associated with an increased odds ratio (OR) for attempting to quit: in educated participants-OR 3.67, 95% confidence interval (CI) 2.10-6.42 in participants with no education-OR 3.98, 95% CI 2.27-6.97. Some biological CVRFs were worse in higher SEP participants while some behavioural risk factors were worse in lower SEP participants. Lower SEP participants had less CVRF screening and knowledge of CVRFs. Those with knowledge of CVRFs were more likely to make healthy behavioural changes. Our findings suggest equipping rural Indians with knowledge about CVRFs may ameliorate projected future increases in CVD.
Publisher: Wiley
Date: 11-2002
DOI: 10.1046/J.1445-2197.2002.02549.X
Abstract: Heterotopic bone formation is a well-established complication of major hip surgery, but traditional reviews of the published literature may have underestimated its frequency. A systematic overview of all the relevant studies was performed to determine reliably the incidence of any heterotopic bone formation and the incidence of each Brooker equivalent grade. Separate estimates were made for patients with total hip replacement and patients with acetabular fracture repair. A computer-based search identified 218 studies with data on the incidence of heterotopic bone formation after either hip replacement or acetabular fracture repair. These studies included data from an estimated 59 121 operated hips among patients that received total hip replacement and an estimated 998 hips among patients that underwent acetabular fracture repair. In these studies, the incidence of any heterotopic bone formation was 43% after total hip replacement and 51% after acetabular fracture repair. The incidence of severe heterotopic bone formation was 9% and 19%, respectively. These results suggest that heterotopic bone formation occurs more frequently after total hip replacement than is generally believed. It is possible that heterotopic bone formation is a more important cause of postoperative disability than has previously been recognized and that effective prophylactic regimens might improve outcome in substantial numbers of patients.
Publisher: MDPI AG
Date: 16-06-2020
DOI: 10.3390/NU12061791
Abstract: In June 2014, Australia and New Zealand adopted a voluntary front-of-pack nutrition label, the Health Star Rating (HSR) system. Our aim was to assess its uptake in Australia in the five years following adoption and examine the feasibility of proposed targets for future uptake. Numbers and proportions of products eligible to carry a HSR were recorded each year between 2014 and 2019 as part of an annual survey of four large Australian retail outlets. Uptake was projected to 2024. Mean HSR values were determined for products that were, and were not labelled with a HSR logo, and summary data presented overall, by HSR score, by major food category, by manufacturer and manufacturer group. Differences in mean HSR were assessed by independent s les t-test. HSR uptake continues to increase, appearing on 7118/17,477 (40.7%) of eligible products in 2019. Voluntary display of the HSR logo was increasing linearly at 6.8% annually. This would need to be maintained to reach 70% by 2024. Of those products displaying a HSR logo, more than three quarters (76.4%) had a HSR ≥ 3.0. Products displaying a HSR logo had a significantly higher mean HSR (3.4), compared to products not displaying a HSR logo (2.6) (p 0.001). One hundred and thirty-nine manufacturers were using HSR, but retailers Coles, Woolworths and ALDI were together responsible for the majority of uptake (55.9%). Manufacturer members of the Australian Food and Grocery Council were responsible for 28.6% of uptake. Our findings illustrate the limits of commercial goodwill in applying HSR voluntarily. Ongoing implementation must pair clear targets and timelines for uptake with a firm pathway to make HSR mandatory if sufficient progress is not achieved.
Publisher: The Endocrine Society
Date: 06-04-2018
Abstract: Insulin resistance has been linked to development and progression of atherosclerosis and is present in most patients with type 2 diabetes. Whether the degree of insulin resistance predicts adverse outcomes in patients with type 2 diabetes and acute coronary syndrome (ACS) is uncertain. The Effect of Aleglitazar on Cardiovascular Outcomes after Acute Coronary Syndrome in Patients with Type 2 Diabetes Mellitus trial compared the peroxisome proliferator-activated receptor-α/γ agonist aleglitazar with placebo in patients with type 2 diabetes and recent ACS. In participants not treated with insulin, we determined whether baseline homeostasis model assessment of insulin resistance (HOMA-IR n = 4303) or the change in HOMA-IR on assigned study treatment (n = 3568) was related to the risk of death or major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in unadjusted and adjusted models. Because an inverse association of HOMA-IR with N-terminal pro-B-type natriuretic peptide (NT-proBNP) has been described, we specifically examined effects of adjustment for the latter. In unadjusted analysis, twofold higher baseline HOMA-IR was associated with lower risk of death [hazard ratio (HR): 0.79, 95% CI: 0.68 to 0.91, P = 0.002]. Adjustment for 24 standard demographic and clinical variables had minimal effect on this association. However, after further adjustment for NT-proBNP, the association of HOMA-IR with death was no longer present (adjusted HR: 0.99, 95% CI: 0.83 to 1.19, P = 0.94). Baseline HOMA-IR was not associated with major adverse cardiovascular events, nor was the change in HOMA-IR on study treatment associated with death or major adverse cardiovascular events. After accounting for levels of NT-proBNP, insulin resistance assessed by HOMA-IR is not related to the risk of death or major adverse cardiovascular events in patients with type 2 diabetes and ACS.
Publisher: Elsevier BV
Date: 09-2021
Publisher: Public Library of Science (PLoS)
Date: 09-02-2016
Publisher: Cambridge University Press (CUP)
Date: 18-07-2018
DOI: 10.1017/S1368980018001702
Abstract: By clearly conveying the healthiness of a food, front-of-pack (FOP) labels have the potential to influence the portion size considered appropriate for consumption. The present study examined the how the Daily Intake Guide (DIG), Multiple Traffic Lights (MTL) and Health Star Rating (HSR) FOP labels affect judgements of appropriate portion sizes of unhealthy foods compared with when no FOP label is present. Respondents viewed mock packages of unhealthy variations of pizzas, cookies, yoghurts and cornflakes featuring the DIG, MTL, HSR or no FOP label, and indicated the portion size they believed should be eaten of each food on a single occasion. The survey was completed on the respondent’s personal computer. A total of 1505 Australian adults provided 4166 ratings across 192 mock packages relating to four product categories: pizza, yoghurt, cornflakes and cookies. Compared with no FOP label, the HSR resulted in a small but significant reduction in the portion size selected as appropriate for consumption of pizzas and cornflakes ( P ·05). The MTL resulted in smaller portions of cornflakes being selected compared with no FOP label ( P ·05). Respondents perceived smaller portion sizes as appropriate for some, but not all, of the foods tested when FOP labels with more interpretative formats (HSR, MTL) appeared on-pack compared with no FOP label. No effect was found for the less interpretive FOP label (the DIG). Interpretive FOP labels may have the potential to influence portion size judgements, albeit at modest levels.
Publisher: American Diabetes Association
Date: 06-2019
DOI: 10.2337/DB19-1206-P
Abstract: The impact of CANA treatment on the initiation of insulin and other antihyperglycemic agents (AHAs) was analyzed in the CANVAS Program, which randomly assigned 10,142 participants with type 2 diabetes and established cardiovascular (CV) disease or ≥2 CV risk factors to treatment with CANA or placebo (PBO). Fewer participants initiated new AHAs with CANA versus PBO (17.8% vs. 27.0% P & .0001). Among those not on insulin at baseline, fewer participants initiated insulin with CANA versus PBO (9.3% vs. 17.8%). The time to initiation of insulin was delayed with CANA versus PBO (Figure). The risk of initiating insulin was 2.6 times lower for participants treated with CANA compared with PBO (hazard ratio [HR] 0.39 [95% CI: 0.33, 0.46] P & .0001). At 312 weeks (6 years), 17.9% and 33.0% of participants treated with CANA and PBO, respectively, had initiated insulin. Delay in insulin initiation was also seen with CANA versus PBO in subgroups by baseline estimated glomerular filtration rate (eGFR) patients with eGFR ≥60 and & mL/min/1.73 m2 had a 2.7 and 1.9 times lower risk of insulin initiation with CANA versus PBO, respectively. In the CANVAS Program, participants treated with CANA initiated fewer AHAs and had longer time to the initiation of insulin compared with participants treated with PBO. The delay in initiation of insulin with CANA may represent reduced utilization of health services and a benefit to patients. D.R. Matthews: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. Consultant Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Servier. Research Support Self Janssen Research & Development. Speaker's Bureau Self Ach& #x00E9 Laboratories, Janssen Research & Development, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. C.H. Wysham: Advisory Panel Self Abbott Laboratories. Board Member Self Endocrine Society. Consultant Self Lexicon Pharmaceuticals, Inc. Research Support Self Mylan. Speaker's Bureau Self AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc. Other Relationship Self Janssen Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. M.J. Davies: Advisory Panel Self Eli Lilly and Company, Janssen Global Services, LLC., Novo Nordisk A/S, Sanofi-Aventis, Servier. Research Support Self Boehringer Ingelheim International GmbH, Novo Nordisk Foundation. Speaker's Bureau Self Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. A. Slee: None. M. Alba: Employee Self Janssen Research & Development. M. Lee: Employee Self Janssen Research & Development. G. Capuano: Employee Self Janssen Research & Development. V. Perkovic: Advisory Panel Self AbbVie Inc., Astellas Pharma Inc., AstraZeneca, Baxter, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Durect Corporation, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Research & Development, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Pharmalink, Relypsa, Inc., Roche Pharma, Sanofi, Servier, Vitae. Research Support Self Australian National Health and Medical Research Council. Other Relationship Self AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc., Janssen Research & Development, Pfizer Inc. K.W. Mahaffey: Consultant Self Abbott, Ablynx, Baim Institute, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cardiometabolic Health Congress, Elsevier, GlaxoSmithKline plc., Medergy, Medscape, Mitsubishi Tanabe Pharma Corporation, MyoKardia, Inc., Novo Nordisk Inc., Ocleuve, Portola Pharmaceuticals, Inc., Radiometer America, Springer Publishing, Theravance, UCSF. Research Support Self Afferent, Amgen Inc., Apple, Car a Medical, Inc, Daiichi, Ferring Pharmaceuticals, Google, Luitpold Pharmaceuticals, Inc., Medtronic, Sanofi, St.Jude, Tenax. Stock/Shareholder Self BioPrint Fitness. Other Relationship Self AstraZeneca, Johnson & Johnson, Merck & Co., Inc., National Institutes of Health, Novartis Pharmaceuticals Corporation. B. Neal: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Pfizer Inc., Roche Pharma, Servier. Research Support Self Abbott, Australian National Health and Medical Research Council, Janssen Research & Development, Merck & Co., Inc., Roche Pharma, Servier. Janssen Research & Development, LLC
Publisher: Oxford University Press (OUP)
Date: 21-03-2017
Abstract: The presence of health claims on food packaging can positively bias consumers' evaluations of foods. This review examined whether cognitive biases endure when other sources of nutrition information [the nutrition facts panel (NFP) and front-of-pack labels] appear on-pack with health claims. The following databases were searched: Web of Science, Ovid, Google Scholar, ScienceDirect, Scopus, ProQuest, and Wiley Online Library. The search terms ("health claim*" OR "nutri* claim") AND ("food label*" OR "front of pack") were used to identify studies. Twenty-four studies that examined health claims and front-of-pack labels or the NFP were included. The NFP can reduce bias, but only if consumers view it and interpret it correctly, which often does not occur. Front-of-pack labels show greater promise in reducing bias created by health claims. These findings are relevant to policymakers who are considering the effectiveness of mandating an NFP and/or a front-of-pack label alongside health claims.
Publisher: Elsevier BV
Date: 03-2022
Publisher: JMIR Publications Inc.
Date: 05-08-2011
DOI: 10.2196/JMIR.1772
Publisher: Elsevier BV
Date: 10-2013
DOI: 10.1016/J.FOODCHEM.2012.10.065
Abstract: Excess energy, saturated fat, sugar and salt from processed and fast foods are a major cause of chronic disease worldwide. In 2010 The Food Monitoring Group established a global branded food composition database to track the nutritional content of foods and make comparisons between countries, food companies and over time. A protocol for the project was agreed and published in 2011 with 24 collaborating countries. Standardised tools and a website have been developed to facilitate data collection and entry. In 2010 data were obtained from nine countries, in 2011 from 12 and in 2012 data are anticipated from 10 additional countries. This collaborative approach to the collation of food composition data offers potential for cross-border collaboration and support in developed and developing countries. The project should contribute significantly to tracking progress of the food industry and governments towards commitments made at the recent UN high level meeting on chronic disease.
Publisher: Elsevier BV
Date: 07-2023
Publisher: American Diabetes Association
Date: 14-04-2020
DOI: 10.2337/DC19-2006
Abstract: Despite evidence of a relationship among obstructive sleep apnea (OSA), metabolic dysregulation, and diabetes, it is uncertain whether OSA treatment can improve metabolic parameters. We sought to determine effects of long-term continuous positive airway pressure (CPAP) treatment on glycemic control and diabetes risk in patients with cardiovascular disease (CVD) and OSA. Blood, medical history, and personal data were collected in a substudy of 888 participants in the Sleep Apnea cardioVascular Endpoints (SAVE) trial in which patients with OSA and stable CVD were randomized to receive CPAP plus usual care, or usual care alone. Serum glucose and glycated hemoglobin A1c (HbA1c) were measured at baseline, 6 months, and 2 and 4 years and incident diabetes diagnoses recorded. Median follow-up was 4.3 years. In those with preexisting diabetes (n = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA1c, or antidiabetic medications during follow-up. There were also no significant between-group differences in participants with prediabetes (n = 452) or new diagnoses of diabetes. Interaction testing suggested that women with diabetes did poorly in the usual care group, while their counterparts on CPAP therapy remained stable. Among patients with established CVD and OSA, we found no evidence that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care treatment. The potential differential effect according to sex deserves further investigation.
Publisher: Public Library of Science (PLoS)
Date: 09-12-2016
Publisher: American Diabetes Association
Date: 07-08-2015
DOI: 10.2337/DC15-0925
Abstract: This study explored whether activation of the receptor for advanced glycation end products (RAGE) is implicated in the development of diabetes complications. A case-cohort study was performed in 3,763 participants with prevalent diabetes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. The hazard ratios (HRs) for death, major cardiovascular events, and new or worsening nephropathy were derived using Cox regression models, and the ability of sRAGE and AGE levels to reclassify the risk of nephropathy was assessed. After adjustment for a range of possible confounders and other risk factors, sRAGE levels were associated with all-cause mortality (HR 1.11 for a 1-SD increase of log sRAGE [95% CI 1.00–1.22] P = 0.045) and new or worsening nephropathy (HR 1.20 for a 1-SD increase of log sRAGE [95% CI 1.02–1.41] P = 0.032). Circulating AGE levels were also independently associated with new or worsening nephropathy (HR 1.21 for a 1-SD increase [95% CI 1.08–1.36] P = 0.001). Both markers also significantly improved the accuracy with which the 5-year risk of new or worsening nephropathy could be predicted (net reclassification index in continuous model, 0.25 for sRAGE and 0.24 for AGE levels). In adults with type 2 diabetes, increased levels of sRAGE are independently associated with new or worsening kidney disease and mortality over the next 5 years. Higher levels of AGE are also associated with an increased risk of adverse renal outcomes. The AGE/RAGE axis may be of importance in the prevention and management of diabetes complications.
Publisher: Elsevier BV
Date: 09-2011
DOI: 10.1016/J.NUMECD.2011.08.001
Abstract: This paper is a Position Statement from an 'ad hoc' Scientific Review Subcommittee of the PAHO/WHO Regional Expert Group on Cardiovascular Disease Prevention through Dietary Salt Reduction. It is produced in response to requests from representatives of countries of the Pan-American Region of WHO needing clarification on two recent publications casting doubts on the appropriateness of population wide policies to reduce salt intake for the prevention of cardiovascular disease. The paper provides a brief background, a critical appraisal of the recent reports and explanations as why the implications have been mis-interpreted. The paper concludes that the benefits of salt reduction are clear and consistent, and reinforces the recommendations outlined by PAHO/WHO and other organizations worldwide for a population reduction in salt intake to prevent strokes, heart attacks and other cardiovascular events.
Publisher: Elsevier BV
Date: 2021
Publisher: MDPI AG
Date: 05-07-2017
DOI: 10.3390/NU9070701
Publisher: Cambridge University Press (CUP)
Date: 02-10-2011
DOI: 10.1016/J.EURPSY.2011.07.005
Abstract: Examine the association of oral disease with future dementia/cognitive decline in a cohort of people with type 2 diabetes. A total of 11,140 men and women aged 55–88 years at study induction with type 2 diabetes participated in a baseline medical examination when they reported the number of natural teeth and days of bleeding gums. Dementia and cognitive decline were ascertained periodically during a 5-year follow-up. Relative to the group with the greatest number of teeth (more than or equal to 22), having no teeth was associated with the highest risk of both dementia (hazard ratio 95% confidence interval: 1.48 1.24, 1.78) and cognitive decline (1.39 1.21, 1.59). Number of days of bleeding gums was unrelated to these outcomes. Tooth loss was associated with an increased risk of both dementia and cognitive decline.
Publisher: Emerald
Date: 25-09-2020
DOI: 10.1108/JBIM-08-2019-0384
Abstract: In response to calls to reduce the gender gap in the salesforce, this study aims to examine the effect of candidate gender, manager gender and industry to explain gender bias in salesperson recruitment during screening and skill assessment. This paper tested the hypotheses using observational data from a national sales competition in the USA, where managers evaluated student candidates for entry-level sales positions. This research finds gender bias during screening using the dyadic perspective. Specifically, female managers evaluate male candidates more favorably than male managers do during screening. Further, managers of service companies evaluate female candidates more favorably than managers of goods companies during screening. However, this paper finds no such effects during candidates’ skill assessment. The findings indicate the importance of using dyadic research techniques to assess gender bias. Managers should not use short interactions to screen candidates. Implicit bias exists when candidates and managers interact during screening. To reduce gender bias in recruitment the candidates and managers should interact for a longer duration. This study draws upon a unique setting, where the candidates interact with the managers for screening and skill assessment. Implicit bias exists when candidates and managers interact for screening under time pressure. This paper finds no evidence of gender bias in skill assessment. This study finds that female managers are more prone to bias when evaluating male candidates than male managers. Prior work has not examined industry-based bias this paper provides evidence of such bias in candidate screening.
Publisher: BMJ
Date: 15-03-2003
Publisher: American Medical Association (AMA)
Date: 11-04-2023
Abstract: Hypertension is the leading risk factor for premature death worldwide. Multiple blood pressure–lowering therapies are available but the potential for maximizing benefit by personalized targeting of drug classes is unknown. To investigate and quantify the potential for targeting specific drugs to specific in iduals to maximize blood pressure effects. A randomized, double-blind, repeated crossover trial in men and women with grade 1 hypertension at low risk for cardiovascular events at an outpatient research clinic in Sweden. Mixed-effects models were used to assess the extent to which in iduals responded better to one treatment than another and to estimate the additional blood pressure lowering achievable by personalized treatment. Each participant was scheduled for treatment in random order with 4 different classes of blood pressure–lowering drugs (lisinopril [angiotensin-converting enzyme inhibitor], candesartan [angiotensin-receptor blocker], hydrochlorothiazide [thiazide], and amlodipine [calcium channel blocker]), with repeated treatments for 2 classes. Ambulatory daytime systolic blood pressure, measured at the end of each treatment period. There were 1468 completed treatment periods (median length, 56 days) recorded in 270 of the 280 randomized participants (54% men mean age, 64 years). The blood pressure response to different treatments varied considerably between in iduals ( P & .001), specifically for the choices of lisinopril vs hydrochlorothiazide, lisinopril vs amlodipine, candesartan vs hydrochlorothiazide, and candesartan vs amlodipine. Large differences were excluded for the choices of lisinopril vs candesartan and hydrochlorothiazide vs amlodipine. On average, personalized treatment had the potential to provide an additional 4.4 mm Hg–lower systolic blood pressure. These data reveal substantial heterogeneity in blood pressure response to drug therapy for hypertension, findings that may have implications for personalized therapy. ClinicalTrials.gov Identifier: NCT02774460
Publisher: Wiley
Date: 04-03-2019
DOI: 10.1111/DOM.13648
Abstract: The use of sodium glucose co-transporter 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) has been limited, primarily because glycaemic efficacy is dependent on kidney function. We performed a systematic review and meta-analysis to assess the efficacy and safety of SGLT2 inhibitors in patients with T2DM and CKD, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m We searched MEDLINE, EMBASE and the Cochrane Library until 7 August 2018 and websites of the US, European and Japanese regulatory authorities until 27 July 2018 for data from randomized controlled trials of SGLT2 inhibitors that included reporting of effects on biomarkers, cardiovascular, renal or safety outcomes in in iduals with T2DM and CKD. Random effects models and inverse variance weighting were used to calculate relative risks with 95% confidence intervals. Data were obtained from 27 studies with up to 7363 participants involved. In patients with T2DM and CKD, SGLT2 inhibitors lowered glycated haemoglobin (-0.29% 95% CI, -0.39 to -0.19) as well as blood pressure, body weight and albuminuria. SGLT2 inhibition reduced the risk of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (RR, 0.81 95% CI, 0.70-0.94) and heart failure (RR, 0.61 95% CI, 0.48-0.78), without a clear effect on all-cause mortality (HR, 0.86 95% CI, 0.73-1.01). These agents also attenuated the annual decline in eGFR slope (placebo-subtracted difference of 1.35 mL/1.73 m Currently available data suggest that, despite only modest reductions in glycated haemoglobin, SGLT2 inhibitors reduce the risk of cardiovascular and renal outcomes in patients with T2DM and CKD, without clear evidence of additional safety concerns.
Publisher: Elsevier BV
Date: 09-2007
Publisher: American Diabetes Association
Date: 02-12-2014
DOI: 10.2337/DC14-1237
Abstract: There are limited data about the effects of sodium–glucose cotransporter 2 inhibitors when used with insulin. We report the efficacy and safety of canagliflozin in patients with type 2 diabetes using insulin. The CANagliflozin CardioVascular Assessment Study is a double-blind, placebo-controlled study that randomized participants to placebo, canagliflozin 100 mg, or canagliflozin 300 mg once daily, added to a range of therapies. The primary end point of this substudy was the change in HbA1c from baseline at 18 weeks among patients using insulin 52-week effects were also examined. In iduals receiving insulin at baseline were randomized to receive placebo (n = 690), canagliflozin 100 mg (n = 692), or canagliflozin 300 mg (n = 690). These in iduals were 66% male and had a median age of 63 years, mean HbA1c of 8.3% (67 mmol/mol), BMI of 33.1 kg/m2, estimated glomerular filtration rate of 75 mL/min/1.73 m2, fasting plasma glucose of 9.2 mmol/L, and a median daily insulin dose of 60 IU. Most in iduals were using basal/bolus insulin. Reductions in HbA1c with canagliflozin 100 and 300 mg versus placebo were −0.62% (95% CI −0.69, −0.54 −6.8 mmol/mol [95% CI −7.5, −5.9] P & 0.001) and −0.73% (95% CI −0.81, −0.65 −8.0 mmol/mol [95% CI −8.9, −7.1] P & 0.001) at 18 weeks and −0.58% (95% CI −0.68, −0.48 −6.3 mmol/mol [95% CI −7.4, −5.2]) and −0.73% (95% CI −0.83, −0.63 −8.0 mmol/mol [95% CI −9.1, −6.9]) at 52 weeks. There were significant falls in fasting plasma glucose, body weight, and blood pressure at both time points and there was a greater incidence of hypoglycemia, genital mycotic infections, and hypovolemia with both canagliflozin doses. Canagliflozin added to insulin therapy improved glycemic control and decreased body weight. There was a greater frequency of several anticipated side effects, although few led to discontinuation of treatment.
Publisher: Elsevier BV
Date: 05-2010
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-05-2022
DOI: 10.1161/CIRCULATIONAHA.121.057736
Abstract: Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of cardiorenal events in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease. However, their effect on hyperkalemia has not been systematically evaluated. A meta-analysis was conducted using in idual participant data from randomized, double-blind, placebo-controlled clinical outcome trials with SGLT2 inhibitors in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease in whom serum potassium levels were routinely measured. The primary outcome was time to serious hyperkalemia, defined as central laboratory–determined serum potassium ≥6.0 mmol/L, with other outcomes including investigator-reported hyperkalemia events and hypokalemia (serum potassium ≤3.5 mmol/L). Cox regression analyses were performed to estimate treatment effects from each trial with hazards ratios and corresponding 95% CIs pooled with random-effects models to obtain summary treatment effects, overall and across key subgroups. Results from 6 trials were included comprising 49 875 participants assessing 4 SGLT2 inhibitors. Of these, 1754 participants developed serious hyperkalemia, and an additional 1119 investigator-reported hyperkalemia events were recorded. SGLT2 inhibitors reduced the risk of serious hyperkalemia (hazard ratio, 0.84 [95% CI, 0.76–0.93]), an effect consistent across studies ( P heterogeneity =0.71). The incidence of investigator-reported hyperkalemia was also lower with SGLT2 inhibitors (hazard ratio, 0.80 [95% CI, 0.68–0.93] P heterogeneity =0.21). Reductions in serious hyperkalemia were observed across a range of subgroups, including baseline kidney function, history of heart failure, and use of renin-angiotensin-aldosterone system inhibitor, diuretic, and mineralocorticoid receptor antagonist. SGLT2 inhibitors did not increase the risk of hypokalemia (hazard ratio, 1.04 [95% CI, 0.94–1.15] P heterogeneity =0.42). SGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia.
Publisher: Oxford University Press (OUP)
Date: 14-12-2015
Abstract: In 2011, the Danish Ministry of Food, Agriculture and Fisheries launched the Danish Organic Action Plan 2020 intending to double the organic agricultural area in Denmark. This study aims to measure experienced physical and psychological wellbeing at work along with beliefs and attitudes among kitchen workers before and after participating in educational training programmes in organic food conversion. This longitudinal study applied an online self-administered questionnaire among kitchen workers before and after the implementation of an organic food conversion programme with 1-year follow-up. The study targeted all staff members in the participating public kitchens taking part in the organic food conversion process funded by the Danish Organic Action Plan 2020. Of the 448 eligible kitchen workers, 235 completed the questionnaire at baseline (52%) and 149 at follow-up (63% of those surveyed at baseline). No substantive differences between baseline and follow-up measurements of organic food conversion were detected on physical or psychological wellbeing at work. Kitchen workers reported a significant improvement in the perceived food quality, motivation to work and application of nutritional guidelines. Reported organic food percentages for the kitchens also increased significantly (P< 0.001) and a shift from using ready-made food products to producing more food from base was indicated. Within 1 year, a significant increase in motivation to work among kitchen staff was observed with no substantive changes in physical or psychological wellbeing at work identified. The results support the Danish Organic Action Plan 2020 and initiatives of similar kind.
Publisher: Oxford University Press (OUP)
Date: 27-03-2014
Abstract: Most in iduals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs ('polypills') would promote use of such medications. We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of ≥15%, with indications for antiplatelet, statin and ≥2 blood pressure lowering drugs ('combination treatment'). Participants randomized to the 'polypill-based strategy' received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to 'usual care' continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol. After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70% vs. 47% relative risk 1.49, (95% confidence interval (CI) 1.30 to 1.72) p < 0.0001 number needed to treat = 4.4 (3.3 to 6.6)) without differences in systolic blood pressure (-1.5 mmHg (95% CI -4.0 to 1.0) p = 0.24) or total cholesterol (0.08 mmol/l (95% CI -0.06 to 0.22) p = 0.26). At study end, 17% and 67% of participants in polypill and usual care groups, respectively, were taking atorvastatin or rosuvastatin. Provision of a polypill improved self-reported use of indicated preventive treatments. The lack of differences in blood pressure and cholesterol may reflect limited study power, although for cholesterol, improved statin use in the polypill group counter-balanced use of more potent statins with usual care.
Publisher: Springer Science and Business Media LLC
Date: 09-07-2018
Publisher: Springer Science and Business Media LLC
Date: 04-02-2014
Publisher: Oxford University Press (OUP)
Date: 24-05-2023
DOI: 10.1093/EURJPC/ZWAD125.028
Abstract: Type of funding sources: None. Dietary sodium has a dose-response relationship with cardiovascular disease, and sodium intake in Sweden exceeds national and international recommendations. Two thirds of dietary sodium intake comes from processed foods, and adults in Sweden eat more processed foods than any other European country. We hypothesised that sodium content in Swedish processed foods is higher than other countries due to the high sodium intake in the Swedish population. To investigate sodium content in Swedish processed food items, and how it differs from Australia, France, Hong Kong, South Africa, the United Kingdom and the United States. Data were collected from retailers by trained research staff using standardised methods. Ten food categories were compared using Kruskal-Wallis test of ranks. Compared to other countries, Sweden had among the highest sodium content in the ‘dairy’ and ‘convenience foods’ categories, but among the lowest in ‘cereal and grain products’, ‘seafood and seafood products’ and ‘snack foods’ categories. The highest sodium contents in the Swedish data were found in the ‘meat and meat products’ category. Contrary to our hypothesis, Swedish processed foods had overall lower sodium content than most other included countries. Sodium content differed substantially between countries in all food categories. Swedish foods had higher sodium content than other countries in increasingly consumed food categories.
Publisher: American Medical Association (AMA)
Date: 12-05-2003
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2005
DOI: 10.1161/01.STR.0000181115.59173.42
Abstract: Background and Purpose— Patients with atrial fibrillation have a high risk of stroke and other vascular events even if anticoagulated. The primary objective here is to determine whether routine blood pressure–lowering provides additional protection for this high-risk patient group. Methods— This study was a subsidiary analysis of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS)—a randomized, placebo-controlled trial that established the beneficial effects of blood pressure–lowering in a heterogeneous group of patients with cerebrovascular disease. A total of 6105 patients were randomly assigned to either active treatment (2 to 4 mg perindopril for all participants plus 2.0 to 2.5 mg indapamide for those without an indication for or a contraindication to a diuretic) or matching placebo(s). Outcomes are total major vascular events, cause-specific vascular outcomes, and death from any cause. Results— There were 476 patients with atrial fibrillation at baseline, of whom 51% were taking anticoagulants. In these patients, active treatment lowered mean blood pressure by 7.3/3.4 mm Hg and was associated with a 38% (95% confidence interval [CI], 6 to 59) reduction in major vascular events and 34% (95% CI, −13 to 61) reduction in stroke. The benefits of blood pressure–lowering in patients with atrial fibrillation were achieved irrespective of the use of anticoagulant therapy ( P homogeneity=0.8) or the presence of hypertension ( P homogeneity=0.4). Conclusions— For most patients with atrial fibrillation, routine blood pressure–lowering is likely to provide protection against major vascular events additional to that conferred by anticoagulation.
Publisher: MDPI AG
Date: 31-05-2021
DOI: 10.3390/NU13061882
Abstract: Unhealthy diets are underpinned by the over-consumption of packaged products. Data describing the ingredient composition of these products is limited. We sought to define the ingredients used in Australian packaged foods and beverages and assess associations between the number of ingredients and existing health indicators. Statements of ingredients were disaggregated, creating separate fields for each ingredient and sub-ingredient. Ingredients were categorised and the average number of ingredients per product was calculated. Associations between number of ingredients and both the nutrient-based Health Star Rating (HSR) and the NOVA level-of-processing classification were assessed. A total of 24,229 products, listing 233,113 ingredients, were included. Products had between 1 and 62 ingredients (median (Interquartile range (IQR)): 8 (3–14)). We identified 915 unique ingredients, which we organised into 17 major and 138 minor categories. ‘Additives’ were contained in the largest proportion of products (64.6%, (15,652/24,229)). The median number of ingredients per product was significantly lower in products with the optimum 5-star HSR (when compared to all other HSR score groups, p-value 0.001) and significantly higher in products classified as ultra-processed (when compared to all other NOVA classification groups, p-value 0.001). There is a strong relationship between the number of ingredients in a product and indicators of nutritional quality and level of processing.
Publisher: Springer Science and Business Media LLC
Date: 11-04-2014
Publisher: MDPI AG
Date: 03-11-2021
Abstract: Monoclonal antibodies including trastuzumab, pertuzumab, and antibody-drug conjugates, form the backbone of HER2-positive breast cancer therapy. Unfortunately, an important adverse effect of these agents is cardiotoxicity, occurring in approximately 10% of patients. There is increasing published data regarding prevention strategies for cardiotoxicity, though seldom used in clinical practice. We performed a systematic review and meta-analysis of randomized-controlled trials to evaluate pharmacotherapy for the prevention of monoclonal HER2-directed antibody-induced cardiotoxicity in patients with breast cancer. Online databases were queried from their inception until October 2021. Effects were determined by calculating risk ratios (RRs) and 95% confidence intervals (CI) or mean differences (MD) using random-effects models. We identified five eligible trials. In the three trials (n = 952) reporting data on the primary outcome of cardiotoxicity, there was no clear effect for patients assigned active treatment compared to control (RR = 0.90, 95% CI 0.63 to 1.29, p = 0.57). Effects were similar for ACE-I/ARB and beta-blockers (p homogeneity = 0.50). Active treatment reduced the risk of HER2 therapy interruptions (RR = 0.57, 95% CI 0.43 to 0.77, p 0.001) with similar findings for ACE-I/ARB and beta-blockers (p homogeneity = 0.97). Prophylactic treatment with ACE-I/ARB or beta-blocker therapy may be of value for cardio-protection in patients with breast cancer prescribed monoclonal antibodies. Further, adequately powered randomized trials are required to define the role of routine prophylactic treatment in this patient group.
Publisher: American Diabetes Association
Date: 03-08-2009
DOI: 10.2337/DC09-0959
Abstract: To assess the magnitude and independence of the effects of routine blood pressure lowering and intensive glucose control on clinical outcomes in patients with long-standing type 2 diabetes. This was a multicenter, factorial randomized trial of perindopril-indapamide versus placebo (double-blind comparison) and intensive glucose control with a gliclazide MR–based regimen (target A1C ≤6.5%) versus standard glucose control (open comparison) in 11,140 participants with type 2 diabetes who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial. Annual event rates and risks of major macrovascular and microvascular events considered jointly and separately, renal events, and death during an average 4.3 years of follow-up were assessed, using Cox proportional hazards models. There was no interaction between the effects of routine blood pressure lowering and intensive glucose control for any of the prespecified clinical outcomes (all P & 0.1): the separate effects of the two interventions for the renal outcomes and death appeared to be additive on the log scale. Compared with neither intervention, combination treatment reduced the risk of new or worsening nephropathy by 33% (95% CI 12–50%, P = 0.005), new onset of macroalbuminuria by 54% (35–68%, P & 0.0001), and new onset of microalbuminuria by 26% (17–34%). Combination treatment was associated with an 18% reduction in the risk of all-cause death (1–32%, P = 0.04). The effects of routine blood pressure lowering and intensive glucose control were independent of one another. When combined, they produced additional reductions in clinically relevant outcomes.
Publisher: MDPI AG
Date: 19-09-2014
DOI: 10.3390/NU6093802
Publisher: American Diabetes Association
Date: 06-2019
DOI: 10.2337/DB19-1203-P
Abstract: T2DM patients have multiple comorbidities and frequent hospitalizations. SGLT2 inhibitors have demonstrated decreased hospitalization for heart failure vs. standard of care, but data on hospitalization for other causes are limited. The CANVAS Program randomly assigned 10,142 participants with T2DM and prior history (secondary prevention n = 6656) or risk (primary prevention n = 3486) for cardiovascular disease to canagliflozin (CANA) or placebo (mean follow-up, 188 week). All-cause hospitalization analyses were prespecified, but analyses of specific causes of hospitalization were not. Microvascular complications included eye, nerve, and kidney and macrovascular complications included cardiac and vascular. CANA reduced overall hospitalization (HR [95% CI]: 0.94 [0.88, 1.00] secondary prevention: 0.91 [0.84, 0.99] primary prevention: 1.01 [0.88, 1.15]). The most common reasons for hospitalization were infection, other, metabolism, cardiovascular, and musculoskeletal (Figure). CANA reduced hospitalization for macrovascular complications (overall: 7.98% vs. 10.63%, P & .0001 secondary prevention: 9.25% vs. 12.66%, P & .0001 primary prevention: 5.86% vs. 7.02%, P = 0.005), but not for microvascular complications (overall: 1.99% vs. 2.20%, P = NS). CANA reduced all-cause hospitalization overall and macrovascular hospitalization in both primary and secondary prevention participants. K.W. Mahaffey: Consultant Self Abbott, Ablynx, Baim Institute, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cardiometabolic Health Congress, Elsevier, GlaxoSmithKline plc., Medergy, Medscape, Mitsubishi Tanabe Pharma Corporation, MyoKardia, Inc., Novo Nordisk Inc., Ocleuve, Portola Pharmaceuticals, Inc., Radiometer America, Springer Publishing, Theravance, UCSF. Research Support Self Afferent, Amgen Inc., Apple, Car a Medical, Inc, Daiichi, Ferring Pharmaceuticals, Google, Luitpold Pharmaceuticals, Inc., Medtronic, Sanofi, St.Jude, Tenax. Stock/Shareholder Self BioPrint Fitness. Other Relationship Self AstraZeneca, Johnson & Johnson, Merck & Co., Inc., National Institutes of Health, Novartis Pharmaceuticals Corporation. J. Ianus: Employee Self Janssen Scientific Affairs, LLC. C.V. Damaraju: Employee Self Janssen Scientific Affairs, LLC. B. Neal: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Pfizer Inc., Roche Pharma, Servier. Research Support Self Abbott, Australian National Health and Medical Research Council, Janssen Research & Development, Merck & Co., Inc., Roche Pharma, Servier. D. de Zeeuw: Advisory Panel Self Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Fresenius Medical Care, Mitsubishi Tanabe Pharma Corporation, Mundipharma. Other Relationship Self AbbVie Inc., Bayer US, Janssen Research & Development. G. Fulcher: Advisory Panel Self Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research & Development, Merck Sharp & Dohme Corp., Novo Nordisk Inc. Consultant Self Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research & Development, Merck Sharp & Dohme Corp., Novo Nordisk Inc. Research Support Self Novo Nordisk Inc. M. Pfeifer: Employee Self Janssen Scientific Affairs, LLC. D.R. Matthews: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. Consultant Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Servier. Research Support Self Janssen Research & Development. Speaker's Bureau Self Aché Laboratories, Janssen Research & Development, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. Janssen Research & Development, LLC
Publisher: Wiley
Date: 03-04-2017
DOI: 10.1111/DOM.12924
Publisher: Elsevier BV
Date: 12-2020
Publisher: Springer Science and Business Media LLC
Date: 27-12-2021
DOI: 10.1186/S13063-021-05915-0
Abstract: Multiple observational studies have associated metformin prescription with reduced progression of abdominal aortic aneurysm (AAA). The Metformin Aneurysm Trial (MAT) will test whether metformin reduces the risk of AAA rupture-related mortality or requirement for AAA surgery (AAA events) in people with asymptomatic aneurysms. MAT is an international, multi-centre, prospective, parallel-group, randomised, placebo-controlled trial. Participants must have an asymptomatic AAA measuring at least 35 mm in maximum diameter, no diabetes, no contraindication to metformin and no current plans for surgical repair. The double-blind period is preceded by a 6-week, single-blind, active run-in phase in which all potential participants receive metformin. Only patients tolerating metformin by taking at least 80% of allocated medication will enter the trial and be randomised to 1500 mg of metformin XR or an identical placebo. The primary outcome is the proportion of AAA events defined as rupture-related mortality or need for surgical repair. Secondary outcomes include AAA growth, major adverse cardiovascular events and health-related quality of life. In order to test if metformin reduced the risk of AAA events by at least 25%, 616 primary outcome events will be required (power 90%, alpha 0.05). Currently, there is no drug therapy for AAA. Past trials have found no convincing evidence of the benefit of multiple blood pressure lowering, antibiotics, a mast cell inhibitor, an anti-platelet drug and a lipid-lowering medication on AAA growth. MAT is one of a number of trials now ongoing testing metformin for AAA. MAT, unlike these other trials, is designed to test the effect of metformin on AAA events. The international collaboration needed for MAT will be challenging to achieve given the current COVID-19 pandemic. If this challenge can be overcome, MAT will represent a trial unique within the AAA field in its large size and design. Australian Clinical Trials ACTRN12618001707257 . Registered on 16 October 2018
Publisher: MDPI AG
Date: 09-10-2017
DOI: 10.3390/NU9101103
Publisher: Elsevier BV
Date: 02-2020
Publisher: Maad Rayan Publishing Company
Date: 11-2021
Abstract: Nutrition policies to improve the food environment frequently rely on voluntary business action for implementation, many have had mixed success. The aims of this study were to identify key food system drivers influencing the Australian packaged food sector and analyse how these might impact the willingness of food companies to voluntarily reduce salt in packaged foods. Business methods formed the basis of this retrospective applied policy analysis of voluntary salt reduction for the period 2013-2016 where the focal policy was the Australian Food and Health Dialogue (2009-2015). The analytical framework included political-legal, economic, social, technological (PEST) external drivers of the food system, and Porter's Five Forces for the competitive drivers of the food system. Documentary data identifying food system drivers affecting the Australian packaged food sector (comprised of the food processing and supermarket industries) were identified through a comprehensive search of the grey and academic literatures. The interplay between external and competitive food system drivers created an environment in which voluntary salt reduction was found to be an uneasy fit. A high cost of doing business, soft growth, intense competition, asymmetry of power in favour of supermarkets, and marginal consumer interest in less salty food were found likely to create commercial disincentives to invest in voluntary salt reduction above more pressing commercial imperatives. Analysis of food manufacturing industries highlighted the highly contextual nature of food system drivers. Opportunities for nutrition policy included: support for 'shared value' in economic discourse and, leveraging investor, supermarket, and the largely unrealised bargaining power of consumers. Business frameworks can provide meaningful insights for nutrition policy on how food system drivers can thwart policy goals. Our analysis highlighted areas to incentivise voluntary action and illustrated the importance of political-legal, economic and consumer strategies for salt reduction.
Publisher: Elsevier BV
Date: 05-2021
Publisher: Springer Science and Business Media LLC
Date: 28-04-2021
DOI: 10.1038/S41467-020-20536-Y
Abstract: Haplotype-resolved genome assemblies are important for understanding how combinations of variants impact phenotypes. To date, these assemblies have been best created with complex protocols, such as cultured cells that contain a single-haplotype (haploid) genome, single cells where haplotypes are separated, or co-sequencing of parental genomes in a trio-based approach. These approaches are impractical in most situations. To address this issue, we present FALCON-Phase, a phasing tool that uses ultra-long-range Hi-C chromatin interaction data to extend phase blocks of partially-phased diploid assembles to chromosome or scaffold scale. FALCON-Phase uses the inherent phasing information in Hi-C reads, skipping variant calling, and reduces the computational complexity of phasing. Our method is validated on three benchmark datasets generated as part of the Vertebrate Genomes Project (VGP), including human, cow, and zebra finch, for which high-quality, fully haplotype-resolved assemblies are available using the trio-based approach. FALCON-Phase is accurate without having parental data and performance is better in s les with higher heterozygosity. For cow and zebra finch the accuracy is 97% compared to 80–91% for human. FALCON-Phase is applicable to any draft assembly that contains long primary contigs and phased associate contigs.
Publisher: Elsevier BV
Date: 11-2022
Publisher: Elsevier BV
Date: 2015
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2021
DOI: 10.1161/STROKEAHA.120.031623
Abstract: Chronic kidney disease with reduced estimated glomerular filtration rate or elevated albuminuria increases risk for ischemic and hemorrhagic stroke. This study assessed the effects of sodium glucose cotransporter 2 inhibitors (SGLT2i) on stroke and atrial fibrillation/flutter (AF/AFL) from CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) and a meta-analysis of large cardiovascular outcome trials (CVOTs) of SGLT2i in type 2 diabetes mellitus. CREDENCE randomized 4401 participants with type 2 diabetes mellitus and chronic kidney disease to canagliflozin or placebo. Post hoc, we estimated effects on fatal or nonfatal stroke, stroke subtypes, and intermediate markers of stroke risk including AF/AFL. Stroke and AF/AFL data from 3 other completed large CVOTs and CREDENCE were pooled using random-effects meta-analysis. In CREDENCE, 142 participants experienced a stroke during follow-up (10.9/1000 patient-years with canagliflozin, 14.2/1000 patient-years with placebo hazard ratio [HR], 0.77 [95% CI, 0.55–1.08]). Effects by stroke subtypes were: ischemic (HR, 0.88 [95% CI, 0.61–1.28] n=111), hemorrhagic (HR, 0.50 [95% CI, 0.19–1.32] n=18), and undetermined (HR, 0.54 [95% CI, 0.20–1.46] n=17). There was no clear effect on AF/AFL (HR, 0.76 [95% CI, 0.53–1.10] n=115). The overall effects in the 4 CVOTs combined were: total stroke (HR pooled , 0.96 [95% CI, 0.82–1.12]), ischemic stroke (HR pooled , 1.01 [95% CI, 0.89–1.14]), hemorrhagic stroke (HR pooled , 0.50 [95% CI, 0.30–0.83]), undetermined stroke (HR pooled , 0.86 [95% CI, 0.49–1.51]), and AF/AFL (HR pooled , 0.81 [95% CI, 0.71–0.93]). There was evidence that SGLT2i effects on total stroke varied by baseline estimated glomerular filtration rate ( P =0.01), with protection in the lowest estimated glomerular filtration rate ( mL/min/1.73 m 2 ]) subgroup (HR pooled , 0.50 [95% CI, 0.31–0.79]). Although we found no clear effect of SGLT2i on total stroke in CREDENCE or across trials combined, there was some evidence of benefit in preventing hemorrhagic stroke and AF/AFL, as well as total stroke for those with lowest estimated glomerular filtration rate. Future research should focus on confirming these data and exploring potential mechanisms. URL: www.clinicaltrials.gov Unique identifier: NCT02065791.
Publisher: Springer Singapore
Date: 2018
Publisher: BMJ
Date: 12-01-2021
DOI: 10.1136/BMJNPH-2020-000173
Abstract: On average, Australian adults consume 3500 mg sodium per day, almost twice the recommended maximum level of intake. The Australian government through the Healthy Food Partnership initiative has developed a voluntary reformulation programme with sodium targets for 27 food categories. We estimated the potential impact of this programme on household sodium purchases (mg/day per capita) and examined potential differences by income level. We also modelled and compared the effects of applying the existing UK reformulation programme targets in Australia. This study used 1 year of grocery purchase data (2018) from a nationally representative consumer panel of Australian households (Nielsen Homescan) that was linked with a packaged food and beverage database (FoodSwitch) that contains product-specific sodium information. Potential reductions in per capita sodium purchases were calculated and differences across income level were assessed by analysis of variance. All analyses were modelled to the Australian population in 2018. A total of 7188 households were included in the analyses. The Healthy Food Partnership targets covered 4307/26 728 (16.1%) unique products, which represented 22.3% of all packaged foods purchased by Australian households in 2018. Under the scenario that food manufacturers complied completely with the targets, sodium purchases will be reduced by 50 mg/day per capita, equivalent to 3.5% of sodium currently purchased from packaged foods. Reductions will be greater in low-income households compared with high-income households (mean difference −7 mg/day, 95% CI −4 to −11 mg/day, p .001). If Australia had adopted the UK sodium targets, this would have covered 9927 unique products, resulting in a reduction in per capita sodium purchases by 110 mg/day. The Healthy Food Partnership reformulation programme is estimated to result in a very small reduction to sodium purchases. There are opportunities to improve the programme considerably through greater coverage and more stringent targets.
Publisher: Elsevier BV
Date: 04-2008
DOI: 10.1038/KI.2008.5
Abstract: Recent epidemiological studies have shown a J-shaped association between the risk of stroke and systolic blood pressure (SBP) levels in people with chronic kidney disease (CKD). The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) was a randomized, placebo-controlled trial demonstrating that perindopril-based blood pressure (BP) lowering reduced the risk of stroke in 6105 participants with prior cerebrovascular disease. We estimated the effects of therapy on the risk of recurrent stroke in 1757 of these participants with stage 3 or greater CKD according to baseline BP and the relationship between achieved follow-up BP and the risk of stroke. Active therapy produced comparable and significant reductions in the risk of stroke across all baseline SBP levels. The age- and gender-adjusted incidence of stroke increased significantly in a log-linear relationship for achieved SBP levels and strokes per 1000 person-years. This association persisted after adjusting for potential confounding factors. We found that perindopril-based BP lowering effectively prevented recurrent stroke in people with CKD, across a wide range of BP levels, without evidence of an increased risk of stroke in people with low BP levels.
Publisher: BMJ
Date: 07-12-2020
Abstract: In rural China, mortality surveillance data may be an alternative to primary data collection in clinical trials SmartVA (verbal autopsy) is also a potential alternative for endpoint adjudication. The feasibility and validity of both need to be assessed. We used mortality data from the first 24 months of the China Salt Substitute and Stroke Study (SSaSS) trial and assessed the agreement between (1) mortality surveillance data and face-to-face visits for fact of death (2) mortality surveillance data and SSaSS adjudication for causes of death (3) SmartVA and SSaSS adjudication for causes of death (4) cause-specific mortality fraction of different methods. Face-to-face visits and SSaSS adjudication were taken as reference methods. The agreement was measured by sensitivity, specificity and positive predictive value (PPV) across different 10th Revision of International Statistical Classification of Diseases chapters. One thousand three hundred and sixty-five deaths were included. Mortality surveillance data had 82% sensitivity for fact of death and 81% sensitivity for causes of death, with substantial variances across different disease types and reasonable quality for circulatory death (91% sensitivity and 94% PPV). The sensitivity of SmartVA for causes of death was 61%, with reasonable quality for deaths of external causes of morbidity (90% sensitivity). The leading causes of death from different sources were the same with some variances in the fractions. Using mortality surveillance data for fact of death in clinical trials need to account for under-reporting. A face-to-face visit to all participants at the completion of trials may be warranted. Neither mortality surveillance data nor SmartVA provided valid data source for endpoint events.
Publisher: Elsevier BV
Date: 12-2017
Publisher: Springer Science and Business Media LLC
Date: 11-05-2016
Publisher: Springer Science and Business Media LLC
Date: 12-2020
DOI: 10.1186/S12966-020-01064-W
Abstract: An amendment to this paper has been published and can be accessed via the original article.
Publisher: Springer International Publishing
Date: 2020
Publisher: Cambridge University Press (CUP)
Date: 03-09-2020
DOI: 10.1017/S0007114520003384
Abstract: Nutrient profiling systems (NPS) are used to classify foods according to their nutritional composition. However, investigating their prospective associations with health is key to their validation. The study investigated the associations of the original Food Standards Agency (FSA)-NPS and three variants (Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC), Health Star Rating NPS and the French High Council of Public Health NPS (HCSP-NPS)), with weight status. In idual dietary indices based on each NPS at the food level were computed to characterise the dietary quality of 71 403 French in iduals from the NutriNet-Santé cohort. Associations of these indices with weight gain were assessed using mixed models and with overweight and obesity risks using Cox models. Participants with a higher dietary index (reflecting lower diet nutritional quality) were more likely to have a significant increase in BMI over time ( β -coefficients positive) and an increased risk of overweight (hazard ratio (HR) T3 v. T1 = 1·27 (95 % CI 1·17, 1·37)) for the HCSP-Dietary Index, followed by the original FSA-Dietary Index (HR T3 v. T1 = 1·18 (95 % CI 1·09, 1·28)), the NPSC-Dietary Index (HR T3 v. T1 = 1·14 (95 % CI 1·06, 1·24)) and the Health Star Rating-Dietary Index (HR T3 v. T1 = 1·12 (95 % CI 1·04, 1·21)). Whilst differences were small, the HCSP-Dietary Index appeared to show significantly greater association with overweight risk. Overall, these results show the validity of NPS derived from the FSA-NPS, supporting their use in public policies for chronic disease prevention.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2019
DOI: 10.1161/STROKEAHA.118.023009
Abstract: This study reports the detailed effects of canagliflozin on stroke, stroke subtypes, and vascular outcomes in participants with and without cerebrovascular disease (stroke or transient ischemic attack) at baseline from the CANVAS (Canagliflozin Cardiovascular Assessment Study) Program. The CANVAS Program, comprising 2 similarly designed and conducted clinical trials, randomly assigned 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk to canagliflozin or placebo. Its primary outcome was a composite of major adverse cardiovascular events. The main outcome of interest for this report was fatal or nonfatal stroke. Additional exploratory outcomes were stroke subtypes and other vascular outcomes defined according to standard criteria. There were 1 958 (19%) participants with prior stroke or transient ischemic attack at baseline. These in iduals were older, more frequently women, and had higher rates of heart failure, atrial fibrillation, and microvascular disease (all P .001) compared with those without such a history. There were 309 participants with stroke events during follow-up (123 had prior stroke or transient ischemic attack at baseline and 186 did not), at a rate of 7.93/1000 patient-years among those assigned canagliflozin and 9.62/1000 patient-years among placebo (hazard ratio, 0.87 95% CI, 0.69–1.09). Analysis of stroke subtypes found no effect on ischemic stroke (n=253, hazard ratio, 0.95 95% CI, 0.74–1.22), a significant reduction for hemorrhagic stroke (n=30, hazard ratio, 0.43 95% CI, 0.20–0.89) and no effect on undetermined stroke (n=29, hazard ratio, 1.04 95% CI, 0.48–2.22). Effects on other cardiovascular outcomes were comparable among participants with and without stroke or transient ischemic attack at baseline. There were too few events in the CANVAS Program to separately define the effects of canagliflozin on stroke, but benefit is more likely than harm. The observed possible protective effect for hemorrhagic stroke was based on small numbers but warrants further investigation. URL: www.clinicaltrials.gov . Unique identifiers: NCT01032629 and NCT01989754.
Publisher: Public Library of Science (PLoS)
Date: 29-03-2017
Publisher: Elsevier BV
Date: 07-2008
DOI: 10.1016/J.ATHEROSCLEROSIS.2007.10.008
Abstract: Asian Indians appear particularly susceptible to coronary heart disease compared with other ethnic groups. We compared the effects of vascular risk factors on carotid intima-media thickness (IMT) in a population of South Asians from Andhra Pradesh, India with a population of Caucasians from Perth, Australia. Cardiovascular risk factors and ultrasound-assessed carotid IMT were measured in randomly selected adults from two villages in rural India (n=303) and compared to those for randomly s led adults from Australia (n=1111). Regression models with interaction terms were used to compare the strengths of associations between risk factors and carotid IMT, in these two populations. There were stronger associations of cholesterol (p for interaction=0.009) and diabetes (p=0.04) with carotid IMT in the Indian compared to the Australian population. Also, while increasing HDL-cholesterol was associated with decreasing carotid IMT in the Australian population the reverse was true for the Indian population (p<0.001). The associations with IMT of blood pressure, triglycerides, age, HDL to total cholesterol ratio, glucose, BMI, waist, waist to hip ratio and smoking were not different between the populations. Greater adverse effects of total cholesterol and diabetes on atherosclerosis and no protective effect of HDL-cholesterol amongst Asian Indians provide a novel possible explanation for observed excess rates of cardiovascular disease amongst these populations.
Publisher: MDPI AG
Date: 16-02-2017
DOI: 10.3390/NU9020144
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2022
DOI: 10.1161/HYPERTENSIONAHA.122.19072
Abstract: Salt substitution (ie, replacement of table and cooking salt with potassium-enriched salt substitutes) is a promising strategy to reduce blood pressure and prevent cardiovascular disease, particularly in countries like India where there is high sodium intake, mainly from discretionary salt, and low potassium intake. Life-threatening hyperkalemia from increased potassium intake is a postulated concern for in iduals with chronic kidney disease. We used comparative risk assessment models to estimate the number of (1) cardiovascular deaths averted due to blood pressure reductions (2) potential hyperkalemia-related deaths from increased potassium intake in in iduals with advanced chronic kidney disease and (3) net averted deaths from nationwide salt substitution in India. We evaluated a conservative scenario, based on a large, long-term pragmatic trial in rural China and an optimistic scenario informed by our recent trial in India. Sensitivity analyses were conducted to assess the robustness of the findings. In the conservative scenario, a nationwide salt substitution intervention was estimated to result in ≈214 000 (95% uncertainty interval, 92 764–353 054) averted deaths from blood pressure reduction in the total population and ≈52 000 (22 961–80 211) in 28 million in iduals with advanced chronic kidney disease, while ≈22 000 (15 221–31 840) hyperkalemia-deaths might be caused by the intervention. The corresponding estimates for the optimistic scenario were ≈351 000 (130 470–546 255), ≈66 000 (24 925–105 851), and ≈9000 (4251–14 599). Net benefits were consistent across sensitivity analyses. Modeling nationwide salt substitution in India consistently estimated substantial net benefits, preventing around 8% to 14% of annual cardiovascular deaths. Even allowing for potential hyperkalemia risks there were net benefits estimated for in iduals with chronic kidney disease.
Publisher: Proceedings of the National Academy of Sciences
Date: 18-01-2022
Abstract: The field of genomics has benefited greatly from its “openness” approach to data sharing. However, with the increasing volume of sequence information being created and stored and the growing number of international genomics efforts, the equity of openness is under question. The United Nations Convention of Bio ersity aims to develop and adopt a standard policy on access and benefit-sharing for sequence information across signatory parties. This standardization will have profound implications on genomics research, requiring a new definition of open data sharing. The redefinition of openness is not unwarranted, as its limitations have unintentionally introduced barriers of engagement to some, including Indigenous Peoples. This commentary provides an insight into the key challenges of openness faced by the researchers who aspire to protect and conserve global bio ersity, including Indigenous flora and fauna, and presents immediate, practical solutions that, if implemented, will equip the genomics community with both the ersity and inclusivity required to respectfully protect global bio ersity.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-02-2021
DOI: 10.2215/CJN.15260920
Abstract: The kidney protective effects of renin-angiotensin system inhibitors are greater in people with higher levels of albuminuria at treatment initiation. Whether this applies to sodium-glucose cotransporter 2 (SGLT2) inhibitors is uncertain, particularly in patients with a very high urine albumin-to-creatinine ratio (UACR ≥3000 mg/g). We examined the association between baseline UACR and the effects of the SGLT2 inhibitor, canagliflozin, on efficacy and safety outcomes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) randomized controlled trial. The study enrolled 4401 participants with type 2 diabetes, an eGFR of 30 to ml/min per 1.73 m 2 , and UACR of to 5000 mg/g. Using Cox proportional hazards regression, we examined the relative and absolute effects of canagliflozin on kidney, cardiovascular, and safety outcomes according to a baseline UACR of ≤1000 mg/g ( n =2348), to mg/g ( n =1547), and ≥3000 mg/g ( n =506). In addition, we examined the effects of canagliflozin on UACR itself, eGFR slope, and the intermediate outcomes of glycated hemoglobin, body weight, and systolic BP. Overall, higher UACR was associated with higher rates of kidney and cardiovascular events. Canagliflozin reduced efficacy outcomes for all UACR levels, with no evidence that relative benefits varied between levels. For ex le, canagliflozin reduced the primary composite outcome by 24% (hazard ratio [HR], 0.76 95% confidence interval [95% CI], 0.56 to 1.04) in the lowest UACR subgroup, 28% (HR, 0.72 95% CI, 0.56 to 0.93) in the UACR subgroup to mg/g, and 37% (HR, 0.63 95% CI, 0.47 to 0.84) in the highest subgroup ( P heterogeneity =0.55). Absolute risk reductions for kidney outcomes were greater in participants with higher baseline albuminuria the number of primary composite events prevented across ascending UACR categories were 17 (95% CI, 3 to 38), 45 (95% CI, 9 to 81), and 119 (95% CI, 35 to 202) per 1000 treated participants over 2.6 years ( P heterogeneity =0.02). Rates of kidney-related adverse events were lower with canagliflozin, with a greater relative reduction in higher UACR categories. Canagliflozin safely reduces kidney and cardiovascular events in people with type 2 diabetes and severely increased albuminuria. In this population, the relative kidney benefits were consistent over a range of albuminuria levels, with greatest absolute kidney benefit in those with an UACR ≥3000 mg/g. ClinicalTrials.gov: CREDENCE, NCT02065791. This article contains a podcast at edia odcast/CJASN/2021_02_22_CJN15260920_final.mp3
Publisher: Elsevier BV
Date: 10-2021
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2008
DOI: 10.1161/STROKEAHA.107.504498
Abstract: Background and Purpose— There are few reports on proinflammatory cytokines and risk of primary or recurrent stroke. We studied the association of interleukin (IL)-6, IL-18, and tumor necrosis factor-α (TNF-α) with recurrent stroke in a nested case-control study derived from the Perindopril Protection Against Recurrent Stroke Study (PROGRESS). Methods— We performed a nested case-control study of 591 strokes (472 ischemic, 83 hemorrhagic, 36 unknown subtype) occurring during a randomized, placebo-controlled multicenter trial of perindopril-based therapy in 6105 patients with a history of stroke or transient ischemic attack. Controls were matched for age, treatment group, sex, region, and most recent qualifying event at entry to the parent trial. Results— IL-6 and TNF-α, but not IL-18, were associated with risk of recurrent ischemic stroke independently of conventional risk markers. Adjusted odds ratios comparing the highest to lowest third of their distributions were 1.33 (95% CI, 1.00 to 1.78) for IL-6 and 1.46 (1.02 to 2.10) for TNF-α. No inflammatory marker was associated with hemorrhagic stroke risk. In multivariable models, IL-6 and TNF-α fully explained observed associations of C-reactive protein and fibrinogen with risk of ischemic stroke, but TNF-α retained borderline significance after full adjustment. Conclusions— Inflammatory markers associated with the acute-phase response (IL-6, TNF-α, C-reactive protein, and fibrinogen, but not IL-18) are associated with risk of recurrent stroke. These markers are dependent on each other in multivariable models, and once all were included, only TNF-α retained a borderline association. Markers of generalized inflammation of the acute-phase response are associated with recurrent stroke, rather than IL-6, C-reactive protein, or fibrinogen in particular.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2010
Publisher: Springer Science and Business Media LLC
Date: 10-08-2019
Publisher: Cambridge University Press (CUP)
Date: 11-2007
DOI: 10.1017/S0007114507754302
Abstract: The cholesterol-lowering effects of plant sterols in a format suitable for use in China have not previously been investigated. We conducted the study to quantify in adult Chinese the effects on blood lipid concentrations of a plant sterol-enriched milk tea powder. The study was a double-blind, randomised trial in which 309 participants were randomised to receive daily 2·3 or 1·5 g plant sterol supplementation or placebo for 5 weeks. The milk tea was consumed with the two fattiest meals of the day with half the assigned daily dose taken on each occasion. Fasting venous blood s les were collected before commencement and upon completion of randomised treatment. The mean age of study participants was 44 years, 62 % were female and 62 % had a history of hypercholesterolaemia. Baseline mean total cholesterol was 5·5 mmol/l and LDL-cholesterol was 3·2 mmol/l. Compared with placebo, the 2·3 g/d plant sterol dose reduced total cholesterol by 0·25 (95 % CI 0·07, 0·43) mmol/l ( P = 0·01) and the 1·5 g/d dose by 0·23 (95 % CI 0·06, 0·41) mmol/l ( P = 0·01). For LDL-cholesterol the corresponding reductions were 0·17 (95 % CI 0·00, 0·35) mmol/l ( P = 0·06) and 0·15 (95 % CI − 0·02, 0·32) mmol/l ( P = 0·08). For neither outcome was there evidence of differences between the effects of the two doses (both P values ·4). In conclusion, the consumption of plant sterol-enriched milk tea decreased cholesterol concentrations although to a lesser extent than was anticipated. The reason for reduced efficacy is unclear but may be attributable to the novel food format used or the Chinese population studied.
Publisher: Elsevier BV
Date: 02-2007
DOI: 10.1016/J.ATHEROSCLEROSIS.2007.02.027
Abstract: Both migrant and local urban populations of Asian Indians have high rates of cardiovascular disease. Metabolic risk factors appear key to this phenomenon but data from rural India are few. We sought to determine the prevalence and distribution of lipids, obesity and metabolic syndrome in a rural region of Andhra Pradesh. S ling was done in 20 villages representative of the project area with an age- and sex-stratified group of 4535 adults > or =30 years selected at random from a local census list. The s le represented 13% of all adults > or =30 years in the 20 villages with a response rate of 81%. All participants had interviewer administered questionnaire, physical examination and fasting finger-prick glucose. Every fourth in idual had venous blood testing for lipid profile (n=1085). Analysis was done using weighting to obtain estimates of risk factor levels for the adult population in the 20 villages. In addition to standard WHO and 2005 NCEP-ATPIII classifications, exploratory 'Asian' definitions were used for overweight and abdominal obesity. The population mean levels of total, LDL, HDL-cholesterol and triglycerides were 4.5 (4.4-4.6) mmol/L, 2.8 (2.7-2.9) mmol/L, 1.1 (1.06-1.13) mmol/L, 1.5 (1.4-1.6) mmol/L for men and 4.8 (4.7-4.9) mmol/L, 3.0 (3.0-3.1) mmol/L, 1.2 (1.16-1.22) mmol/L, 1.3 (1.2-1.4) mmol/L for women. 18.4% of men and 26.3% of women were overweight rising to 32.4% of men and 41.4% of women if 'Asian' definitions were used. Criteria for NCEP-ATPIII metabolic syndrome were met by 26.9% of men and 18.4% of women with figures of 32.5% and 23.9%, respectively, if 'Asian' waist cut-offs were substituted. Dyslipidaemia, adiposity and metabolic syndrome were common in this rural Indian population and prevalence was much greater if proposed Asian definitions for adiposity were used. Metabolic risk factors likely play a major role in cardiovascular disease in this region.
Publisher: Elsevier BV
Date: 02-2009
Abstract: Processed foods are major contributors to population dietary salt intake. Parts of the Australian food industry have started to decrease salt in a number of products. A definitive baseline assessment of current sodium concentrations in foods is key to targeting reformulation strategies and monitoring progress. Our objectives were to systematically collate data on the sodium content of Australian processed food products and compare sodium values against maximum target levels established by the UK Food Standards Agency (UK FSA). Categories of processed foods that contribute the majority of salt to Australian diets were identified. Food-composition data were sought for all products in these categories, and the sodium content in mg/100 g (or mg/100 mL for liquids) was recorded for each. Mean sodium values were calculated for each grouping and compared with the UK FSA benchmarks. Sodium data were collected for 7221 products in 10 food groups, 33 food categories, and 90 food subcategories. The food groups that were highest in sodium were sauces and spreads (1283 mg/100 g) and processed meats (846 mg/100 g). Cereal and cereal products (206 mg/100 g) and fruit and vegetables (211 mg/100 g) were the lowest in sodium. Sixty-three percent of food categories had mean sodium concentrations above the UK FSA targets, and most had wide ranges between the most and least salty product. Many products, particularly breads, processed meats, and sauces, have salt amounts above reasonable benchmarks. The variation in salt concentrations between comparable products suggests that reformulation is highly feasible for many foods.
Publisher: Springer Science and Business Media LLC
Date: 07-2001
DOI: 10.1007/S11906-001-0097-4
Abstract: Randomized trials have provided clear evidence of the beneficial effects of many different blood pressure-lowering regimens compared with placebo. The comparative effects of antihypertensive regimens based on different drug classes are less well established. The Blood Pressure Lowering Treatment Trialists' Collaboration conducted a series of prospectively designed overviews of randomized trials that compared the effects of different drug classes on major cause-specific outcomes. These overviews found no differences between the effects of regimens based on angiotensin converting enzyme inhibitors and those based on diuretics or b-blockers. There was limited evidence of small differences between regimens based on calcium antagonists and those based on diuretics or beta-blockers. The overviews of regimens based on calcium antagonists compared with those based on angiotensin converting enzyme inhibitors recorded too few events to provide reliable findings. Over the next few years, the findings of ongoing trials and future cycles of overview analyses conducted by the Collaboration should substantially add to these data.
Publisher: Wiley
Date: 24-06-2020
DOI: 10.1111/DOM.14091
Publisher: American Diabetes Association
Date: 23-06-2015
DOI: 10.2337/DC15-ER07
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2005
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12072
Abstract: The International Network for Food and Obesity/non-communicable diseases Research, Monitoring and Action Support (INFORMAS) proposes to collect performance indicators on food policies, actions and environments related to obesity and non-communicable diseases. This paper reviews existing communications strategies used for performance indicators and proposes the approach to be taken for INFORMAS. Twenty-seven scoring and rating tools were identified in various fields of public health including alcohol, tobacco, physical activity, infant feeding and food environments. These were compared based on the types of indicators used and how they were quantified, scoring methods, presentation and the communication and reporting strategies used. There are several implications of these analyses for INFORMAS: the ratings/benchmarking approach is very commonly used, presumably because it is an effective way to communicate progress and stimulate action, although this has not been formally evaluated the tools used must be trustworthy, pragmatic and policy-relevant multiple channels of communication will be needed communications need to be tailored and targeted to decision-makers data and methods should be freely accessible. The proposed communications strategy for INFORMAS has been built around these lessons to ensure that INFORMAS's outputs have the greatest chance of being used to improve food environments.
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12073
Abstract: Government action is essential to increase the healthiness of food environments and reduce obesity, diet-related non-communicable diseases (NCDs), and their related inequalities. This paper proposes a monitoring framework to assess government policies and actions for creating healthy food environments. Recommendations from relevant authoritative organizations and expert advisory groups for reducing obesity and NCDs were examined, and pertinent components were incorporated into a comprehensive framework for monitoring government policies and actions. A Government Healthy Food Environment Policy Index (Food-EPI) was developed, which comprises a 'policy' component with seven domains on specific aspects of food environments, and an 'infrastructure support' component with seven domains to strengthen systems to prevent obesity and NCDs. These were revised through a week-long consultation process with international experts. Ex les of good practice statements are proposed within each domain, and these will evolve into benchmarks established by governments at the forefront of creating and implementing food policies for good health. A rating process is proposed to assess a government's level of policy implementation towards good practice. The Food-EPI will be pre-tested and piloted in countries of varying size and income levels. The benchmarking of government policy implementation has the potential to catalyse greater action to reduce obesity and NCDs.
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12074
Abstract: Private-sector organizations play a critical role in shaping the food environments of in iduals and populations. However, there is currently very limited independent monitoring of private-sector actions related to food environments. This paper reviews previous efforts to monitor the private sector in this area, and outlines a proposed approach to monitor private-sector policies and practices related to food environments, and their influence on obesity and non-communicable disease (NCD) prevention. A step-wise approach to data collection is recommended, in which the first ('minimal') step is the collation of publicly available food and nutrition-related policies of selected private-sector organizations. The second ('expanded') step assesses the nutritional composition of each organization's products, their promotions to children, their labelling practices, and the accessibility, availability and affordability of their products. The third ('optimal') step includes data on other commercial activities that may influence food environments, such as political lobbying and corporate philanthropy. The proposed approach will be further developed and piloted in countries of varying size and income levels. There is potential for this approach to enable national and international benchmarking of private-sector policies and practices, and to inform efforts to hold the private sector to account for their role in obesity and NCD prevention.
Publisher: MDPI AG
Date: 17-10-2017
DOI: 10.3390/NU9101128
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12075
Abstract: A food supply that delivers energy-dense products with high levels of salt, saturated fats and trans fats, in large portion sizes, is a major cause of non-communicable diseases (NCDs). The highly processed foods produced by large food corporations are primary drivers of increases in consumption of these adverse nutrients. The objective of this paper is to present an approach to monitoring food composition that can both document the extent of the problem and underpin novel actions to address it. The monitoring approach seeks to systematically collect information on high-level contextual factors influencing food composition and assess the energy density, salt, saturated fat, trans fats and portion sizes of highly processed foods for sale in retail outlets (with a focus on supermarkets and quick-service restaurants). Regular surveys of food composition are proposed across geographies and over time using a pragmatic, standardized methodology. Surveys have already been undertaken in several high- and middle-income countries, and the trends have been valuable in informing policy approaches. The purpose of collecting data is not to exhaustively document the composition of all foods in the food supply in each country, but rather to provide information to support governments, industry and communities to develop and enact strategies to curb food-related NCDs.
Publisher: Cambridge University Press (CUP)
Date: 31-10-2018
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12076
Abstract: Food and non-alcoholic beverage marketing is recognized as an important factor influencing food choices related to non-communicable diseases. The monitoring of populations' exposure to food and non-alcoholic beverage promotions, and the content of these promotions, is necessary to generate evidence to understand the extent of the problem, and to determine appropriate and effective policy responses. A review of studies measuring the nature and extent of exposure to food promotions was conducted to identify approaches to monitoring food promotions via dominant media platforms. A step-wise approach, comprising 'minimal', 'expanded' and 'optimal' monitoring activities, was designed. This approach can be used to assess the frequency and level of exposure of population groups (especially children) to food promotions, the persuasive power of techniques used in promotional communications (power of promotions) and the nutritional composition of promoted food products. Detailed procedures for data s ling, data collection and data analysis for a range of media types are presented, as well as quantifiable measurement indicators for assessing exposure to and power of food and non-alcoholic beverage promotions. The proposed framework supports the development of a consistent system for monitoring food and non-alcoholic beverage promotions for comparison between countries and over time.
Publisher: Springer Science and Business Media LLC
Date: 27-02-2009
DOI: 10.1038/HR.2009.7
Abstract: Reduced-sodium, increased-potassium salt substitutes lower blood pressure but may also have direct effects on vascular structure and arterial function. This study aimed to test the effects of long-term salt substitution on indices of these outcomes. The China Salt Substitute Study was a randomized, controlled trial designed to establish the effects of salt substitute (65% sodium chloride, 25% potassium chloride, 10% magnesium sulfate) compared with regular salt (100% sodium chloride) on blood pressure among 600 high-risk in iduals living in six rural areas in northern China over a 12-month intervention period. Data on central aortic blood pressure, aortic pressure augmentation (AUG), augmentation index (AIx), the differences of the peak of first and baseline waves (P(1)-P(0)) and pulse wave reflection time (RT) were collected at randomization and at the completion of follow-up in 187 participants using the Sphygmocor pulse wave analysis system. Mean baseline blood pressure was 150.1/91.4 mm Hg, mean age was 58.4 years, 41% were male and three quarters had a history of vascular disease. After 12 months of intervention, there were significant net reductions in peripheral (7.4 mm Hg, P=0.009) and central (6.9 mm Hg, P=0.011) systolic blood pressure levels and central pulse pressure (4.5 mm Hg, P=0.012) and correspondingly there was a significant net reduction in P(1)-P(0) (3.0 mm Hg, P=0.007), borderline significant net reduction in AUG (1.5 mm Hg, P=0.074) and significant net increase in RT (2.59 ms, P=0.001). There were no detectable reductions in peripheral (2.8 mm Hg, P=0.14) or central (2.4 mm Hg, P=0.13) diastolic blood pressure levels or AIx (0.06%, P=0.96). In conclusion, over the 12-month study period the salt substitute significantly reduced not only peripheral and central systolic blood pressure but also reduced arterial stiffness.
Publisher: Springer Science and Business Media LLC
Date: 23-10-2012
DOI: 10.1038/TP.2012.100
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-02-2020
Abstract: Several trials have demonstrated protective effects from inhibition of sodium‐glucose cotransporter 2 among patients with type 2 diabetes mellitus. There is uncertainty about the consistency of the cardiovascular benefits achieved across patient subsets. We included 4 large‐scale trials of sodium‐glucose cotransporter 2 inhibition compared with placebo in patients with diabetes mellitus that reported effects on cardiovascular outcomes overall and for participant subgroups defined at baseline by cardiovascular disease, reduced kidney function, and heart failure. Fixed effects models with inverse variance weighting were used to estimate summary hazard ratios and 95% CIs . There were 38 723 patients from 4 trials, with a mean 2.9 years of follow‐up. Of the patients, 22 870 (59%) had cardiovascular disease, 7754 (20%) had reduced kidney function, and 4543 (12%) had heart failure. There were 3828 major adverse cardiac events. There was overall benefit for major adverse cardiac events (0.88 95% CI , 0.82–0.94 P .001) and no evidence that the effects of sodium‐glucose cotransporter 2 inhibition varied across patient subgroups, defined by the presence of cardiovascular disease or heart failure at baseline (all P interaction .252 I 2 %). All patient subgroups benefited with respect to hospitalization for heart failure (all P interaction .302 I 2 %), cardiovascular death (all P interaction .167 I 2 %), and death from any cause (all P interaction .354 I 2 =0%). The only difference in effects across subgroups was for stroke, with protection observed among those with reduced kidney function but not those with preserved kidney function ( P interaction=0.020 I 2 =81%). Sodium‐glucose cotransporter 2 inhibitors protect against cardiovascular disease and death in erse subsets of patients with type 2 diabetes mellitus regardless of cardiovascular disease history.
Publisher: MDPI AG
Date: 02-12-2016
DOI: 10.3390/NU8120787
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 17-05-2022
DOI: 10.1161/CIRCULATIONAHA.122.059573
Abstract: SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among in iduals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention. A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models. Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77–0.96] P =0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a .9% probability of being cost-effective. Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants.
Publisher: Massachusetts Medical Society
Date: 08-12-2016
DOI: 10.1056/NEJMC1613219
Publisher: Elsevier BV
Date: 06-2017
DOI: 10.1016/J.AHJ.2017.02.033
Abstract: Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2020
DOI: 10.1161/HYPERTENSIONAHA.119.14302
Abstract: We report on an analysis to explore the association between estimated 24-hour urinary sodium excretion (surrogate for sodium intake) and incident cardiovascular disease (CVD) and mortality. Data were obtained from 398 628 UK Biobank prospective cohort study participants (40–69 years) recruited between 2006 and 2010, with no history of CVD, renal disease, diabetes mellitus or cancer, and cardiovascular events and mortality recorded during follow-up. Hazard ratios between 24-hour sodium excretion were estimated from spot urinary sodium concentrations across incident CVD and its components and all-cause and cause-specific mortality. In restricted cubic splines analyses, there was little evidence for an association between estimated 24-hour sodium excretion and CVD, coronary heart disease, or stroke hazard ratios for CVD (95% CIs) for the 15th and 85th percentiles (2.5 and 4.2 g/day, respectively) compared with the 50th percentile of estimated sodium excretion (3.2 g/day) were 1.05 (1.01–1.10) and 0.96 (0.92–1.00), respectively. An inverse association was observed with heart failure, but that was no longer apparent in sensitivity analysis. A J-shaped association was observed between estimated sodium excretion and mortality. Our findings do not support a J-shaped association of estimated sodium excretion with CVD, although such an association was apparent for all-cause and cause-specific mortality across a wide range of diseases. Reasons for these differences are unclear methodological limitations, including the use of estimating equations based on spot urinary data, need to be considered in interpreting our findings.
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12077
Abstract: Food labelling on food packaging has the potential to have both positive and negative effects on diets. Monitoring different aspects of food labelling would help to identify priority policy options to help people make healthier food choices. A taxonomy of the elements of health-related food labelling is proposed. A systematic review of studies that assessed the nature and extent of health-related food labelling has been conducted to identify approaches to monitoring food labelling. A step-wise approach has been developed for independently assessing the nature and extent of health-related food labelling in different countries and over time. Procedures for s ling the food supply, and collecting and analysing data are proposed, as well as quantifiable measurement indicators and benchmarks for health-related food labelling.
Publisher: Informa UK Limited
Date: 06-12-2016
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2017
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12078
Abstract: Food prices and food affordability are important determinants of food choices, obesity and non-communicable diseases. As governments around the world consider policies to promote the consumption of healthier foods, data on the relative price and affordability of foods, with a particular focus on the difference between 'less healthy' and 'healthy' foods and diets, are urgently needed. This paper briefly reviews past and current approaches to monitoring food prices, and identifies key issues affecting the development of practical tools and methods for food price data collection, analysis and reporting. A step-wise monitoring framework, including measurement indicators, is proposed. 'Minimal' data collection will assess the differential price of 'healthy' and 'less healthy' foods 'expanded' monitoring will assess the differential price of 'healthy' and 'less healthy' diets and the 'optimal' approach will also monitor food affordability, by taking into account household income. The monitoring of the price and affordability of 'healthy' and 'less healthy' foods and diets globally will provide robust data and benchmarks to inform economic and fiscal policy responses. Given the range of methodological, cultural and logistical challenges in this area, it is imperative that all aspects of the proposed monitoring framework are tested rigorously before implementation.
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12079
Abstract: This paper outlines a step-wise framework for monitoring foods and beverages provided or sold in publicly funded institutions. The focus is on foods in schools, but the framework can also be applied to foods provided or sold in other publicly funded institutions. Data collection and evaluation within this monitoring framework will consist of two components. In component I, information on existing food or nutrition policies and/or programmes within settings would be compiled. Currently, nutrition standards and voluntary guidelines associated with such policies rogrammes vary widely globally. This paper, which provides a comprehensive review of such standards and guidelines, will facilitate institutional learnings for those jurisdictions that have not yet established them or are undergoing review of existing ones. In component II, the quality of foods provided or sold in public sector settings is evaluated relative to existing national or sub-national nutrition standards or voluntary guidelines. Where there are no (or only poor) standards or guidelines available, the nutritional quality of foods can be evaluated relative to standards of a similar jurisdiction or other appropriate standards. Measurement indicators are proposed (within 'minimal', 'expanded' and 'optimal' approaches) that can be used to monitor progress over time in meeting policy objectives, and facilitate comparisons between countries.
Publisher: Springer Science and Business Media LLC
Date: 06-1997
Abstract: Saroglitazar is a newer antidiabetic agent approved to manage dyslipidemia. The objective is tevaluate the efficacy and safety profiles of saroglitazar in patients with dyslipidemia. A systematic search was conducted using PubMed, Cochrane Library, Scopus, and Google Scholar from the inception until January 2022. Interventional studies comparing the anti-hyperlipidaemic effect and safety of saroglitazar with or without a control group(s) were included. The efficacy of saroglitazar was assessed concerning its effect on total cholesterol, low density lipoprotein (LDL) and high density lipoprotein (HDL)-cholesterol, triglycerides, fasting plasma glucose, and non-HDL cholesterol. The effects on serum creatinine levels, bodyweight reduction, alanine aminotransferase and aspartate aminotransferase were considered to be safety endpoint.The Cochrane risk of bias assessment tool was used to assess the methodological quality of the included studies. A total of six studies with 581 adults with a mean age ranging from 40.2 to 62.6 years were included in this study. A significant decrease in low-density lipoprotein cholesterol was observed with saroglitazar 4 mg therapy compared to saroglitazar 2 mg [standardized mean difference (SMD): -0.23 mg/dL, 95% CI: -0.47 to 0.00 p = 0.05 2 studies], and control [SMD: -0.36 mg/dL, 95% CI -0.59 to -0.12 p = 0.0026 3 studies]. Also, a significant decrease in the total cholesterol was observed with saroglitazar 4 mg therapy compared to saroglitazar 2 mg [SMD - 0.28 mg/dL, 95% CI: - 0.52 to -0.04 p < 0.01 2 studies], and control [SMD - 0.49 mg/dL, 95% CI: - 0.72 to -0.26 p < 0.0001 3 studies]. Saroglitazar was not associated with adverse effects such as increase in serum creatinine levels, alanine aminotransferase and aspartate aminotransferase and bodyweight reduction. Saroglitazar appeared to be an effective and safer therapeutic option for improving dyslipidemia in patients. However, comparative studies of saroglitazar with the other pharmacological agents are warranted.
Publisher: American Diabetes Association
Date: 06-2019
DOI: 10.2337/DB19-1216-P
Abstract: Sodium glucose co-transporter 2 (SGLT2) inhibitors reduce serum uric acid levels. We investigated the effect of canagliflozin compared to placebo on gout in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program. The CANVAS Program randomly assigned 10,142 participants with type 2 diabetes to canagliflozin or placebo. Adverse events and serious adverse events attributed to gout, hyperuricemia or hyperuricosuria were identified and the effects of canagliflozin compared to placebo were estimated by calculating the hazard ratio (HR) and 95% confidence interval (95% CI). Mean serum urate levels at baseline were 348.2 (standard deviation 94.3) µmol/L in the canagliflozin group and 349.8 (97.1) µmol/L in the placebo group. Serum urate levels were 23.2 µmol/L (95% CI: -25.6 to -20.9) lower in the canagliflozin versus placebo group at 6 to 13 weeks after randomization and on average were 23.3 µmol/L (95% CI: -25.4 to -21.3) lower during follow-up. There were 80 in iduals who reported gout and 76 who reported hyperuricemia or hyperuricosuria during follow-up. The HR for gout was 0.64 (95% CI: 0.41 to 0.99) in those treated with canagliflozin compared to placebo. The corresponding HR for hyperuricemia or hyperuricosuria was 0.57 (95% CI: 0.36 to 0.90) and the HR for a gout, hyperuricemia or hyperuricosuria event was 0.62 (95% CI: 0.45 to 0.85). Canagliflozin reduced serum urate levels and the risk of adverse events attributed to gout. J. Li: Employee Self George Institute for Global Health. S.V. Badve: None. Z. Zhou: None. R. Oh: Employee Self Janssen Research & Development. M. Lee: Employee Self Janssen Research & Development. V. Perkovic: Advisory Panel Self AbbVie Inc., Astellas Pharma Inc., AstraZeneca, Baxter, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Durect Corporation, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Research & Development, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Pharmalink, Relypsa, Inc., Roche Pharma, Sanofi, Servier, Vitae. Research Support Self Australian National Health and Medical Research Council. Other Relationship Self AbbVie Inc., Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc., Janssen Research & Development, Pfizer Inc. D. de Zeeuw: Advisory Panel Self Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Fresenius Medical Care, Mitsubishi Tanabe Pharma Corporation, Mundipharma. Other Relationship Self AbbVie Inc., Bayer US, Janssen Research & Development. K.W. Mahaffey: Consultant Self Abbott, Ablynx, Baim Institute, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cardiometabolic Health Congress, Elsevier, GlaxoSmithKline plc., Medergy, Medscape, Mitsubishi Tanabe Pharma Corporation, MyoKardia, Inc., Novo Nordisk Inc., Ocleuve, Portola Pharmaceuticals, Inc., Radiometer America, Springer Publishing, Theravance, UCSF. Research Support Self Afferent, Amgen Inc., Apple, Car a Medical, Inc, Daiichi, Ferring Pharmaceuticals, Google, Luitpold Pharmaceuticals, Inc., Medtronic, Sanofi, St.Jude, Tenax. Stock/Shareholder Self BioPrint Fitness. Other Relationship Self AstraZeneca, Johnson & Johnson, Merck & Co., Inc., National Institutes of Health, Novartis Pharmaceuticals Corporation. G. Fulcher: Advisory Panel Self Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research & Development, Merck Sharp & Dohme Corp., Novo Nordisk Inc. Consultant Self Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Research & Development, Merck Sharp & Dohme Corp., Novo Nordisk Inc. Research Support Self Novo Nordisk Inc. D.R. Matthews: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. Consultant Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Servier. Research Support Self Janssen Research & Development. Speaker's Bureau Self Ach& #x00E9 Laboratories, Janssen Research & Development, Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi, Servier. B. Neal: Advisory Panel Self Janssen Research & Development, Novartis Pharmaceuticals Corporation, Pfizer Inc., Roche Pharma, Servier. Research Support Self Abbott, Australian National Health and Medical Research Council, Janssen Research & Development, Merck & Co., Inc., Roche Pharma, Servier. Janssen Research & Development, LLC
Publisher: Springer Science and Business Media LLC
Date: 11-08-2010
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12081
Abstract: The liberalization of international trade and foreign direct investment through multilateral, regional and bilateral agreements has had profound implications for the structure and nature of food systems, and therefore, for the availability, nutritional quality, accessibility, price and promotion of foods in different locations. Public health attention has only relatively recently turned to the links between trade and investment agreements, diets and health, and there is currently no systematic monitoring of this area. This paper reviews the available evidence on the links between trade agreements, food environments and diets from an obesity and non-communicable disease (NCD) perspective. Based on the key issues identified through the review, the paper outlines an approach for monitoring the potential impact of trade agreements on food environments and obesity/NCD risks. The proposed monitoring approach encompasses a set of guiding principles, recommended procedures for data collection and analysis, and quantifiable 'minimal', 'expanded' and 'optimal' measurement indicators to be tailored to national priorities, capacity and resources. Formal risk assessment processes of existing and evolving trade and investment agreements, which focus on their impacts on food environments will help inform the development of healthy trade policy, strengthen domestic nutrition and health policy space and ultimately protect population nutrition.
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12082
Abstract: INFORMAS (International Network for Food and Obesity/non-communicable diseases Research, Monitoring and Action Support) aims to monitor and benchmark the healthiness of food environments globally. In order to assess the impact of food environments on population diets, it is necessary to monitor population diet quality between countries and over time. This paper reviews existing data sources suitable for monitoring population diet quality, and assesses their strengths and limitations. A step-wise framework is then proposed for monitoring population diet quality. Food balance sheets (FBaS), household budget and expenditure surveys (HBES) and food intake surveys are all suitable methods for assessing population diet quality. In the proposed 'minimal' approach, national trends of food and energy availability can be explored using FBaS. In the 'expanded' and 'optimal' approaches, the dietary share of ultra-processed products is measured as an indicator of energy-dense, nutrient-poor diets using HBES and food intake surveys, respectively. In addition, it is proposed that pre-defined diet quality indices are used to score diets, and some of those have been designed for application within all three monitoring approaches. However, in order to enhance the value of global efforts to monitor diet quality, data collection methods and diet quality indicators need further development work.
Publisher: Elsevier BV
Date: 05-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 15-01-2019
Publisher: Wiley
Date: 17-09-2013
DOI: 10.1111/OBR.12087
Abstract: Non-communicable diseases (NCDs) dominate disease burdens globally and poor nutrition increasingly contributes to this global burden. Comprehensive monitoring of food environments, and evaluation of the impact of public and private sector policies on food environments is needed to strengthen accountability systems to reduce NCDs. The International Network for Food and Obesity/NCDs Research, Monitoring and Action Support (INFORMAS) is a global network of public-interest organizations and researchers that aims to monitor, benchmark and support public and private sector actions to create healthy food environments and reduce obesity, NCDs and their related inequalities. The INFORMAS framework includes two 'process' modules, that monitor the policies and actions of the public and private sectors, seven 'impact' modules that monitor the key characteristics of food environments and three 'outcome' modules that monitor dietary quality, risk factors and NCD morbidity and mortality. Monitoring frameworks and indicators have been developed for 10 modules to provide consistency, but allowing for stepwise approaches ('minimal', 'expanded', 'optimal') to data collection and analysis. INFORMAS data will enable benchmarking of food environments between countries, and monitoring of progress over time within countries. Through monitoring and benchmarking, INFORMAS will strengthen the accountability systems needed to help reduce the burden of obesity, NCDs and their related inequalities.
Publisher: JMIR Publications Inc.
Date: 09-03-2023
DOI: 10.2196/43675
Abstract: Even modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. Our aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. A 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. A total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI −331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI −1083 to 1347) mg for urinary potassium excretion, −0.66 (95% CI −3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI −21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. In this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19–related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. Australian New Zealand Clinical Trials Registry ACTRN12619000352101 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471
Publisher: Elsevier BV
Date: 05-2020
Publisher: Emerald
Date: 19-06-2020
DOI: 10.1108/JBIM-09-2019-0401
Abstract: This paper aims to argue that engagement with industry in research, while costly in terms of time and effort, can provide benefits in terms of measurable research impact, particularly in the business-to-business (B2B) domain. This study draws joint experiences about how best to connect with an industry organization, how to engage with that organization and how to provide and document impact by transforming some aspect of that organization. The findings of this study provide practical and implementable suggestions on how to engage in impactful B2B research. This study discusses the special nature of the B2B domain and why engagement with industry is especially important and beneficial. Though such research may not be appropriate for all academics, this study argues that its high rewards more than compensate for its high costs.
Publisher: Informa UK Limited
Date: 2004
DOI: 10.1080/08037050410029605
Abstract: Analyses of the risks of stroke were conducted for subjects with and without diabetes, participating in a randomized, double-blind, placebo-controlled trial of a perindopril-based blood pressure lowering regimen in 6105 people with prior stroke or transient ischaemic attack (TIA), followed for a median of 3.9 years. Seven hundred and sixty-one patients had diabetes at baseline. Diabetes increased the risk of recurrent stroke by 35% (95% CI 10-65%) principally through an effect on ischaemic stroke (1.53, 95% CI 1.23-1.90). Active treatment reduced blood pressure by 9.5/4.6 mmHg in patients with diabetes and by 8.9/3.9 mmHg in patients without diabetes. The proportional risk reductions achieved for stroke in patients with diabetes, 38% (95% CI 8-58%), and patients without diabetes, 28% (95% CI 16-39%), were not significantly different (p homogeneity = 0.5). The absolute reduction in the risk of recurrent stroke in the patients with diabetes was equivalent to one stroke avoided among every 16 (95% CI 9-111) patients treated for 5 years. Diabetes is an important risk factor for stroke in patients with established cerebrovascular disease. Treatment with the ACE inhibitor perindopril with discretionary use of the diuretic indapamide produced reductions in the risk of recurrent stroke in patients with diabetes that were at least as great as those achieved in patients without diabetes.
Publisher: Elsevier BV
Date: 07-2017
Publisher: Elsevier BV
Date: 12-2018
DOI: 10.1093/AJCN/NQY248
Abstract: As a public health intervention, front-of-pack labels (FoPLs) have the potential to reach large numbers of consumers and promote healthier food choices. Of the different FoPLs, those that summarize a product's overall nutritional profile tend to be most effective in guiding healthier choices. However, information is lacking as to whether FoPLs are as effective when nutrient or health claims also appear on-pack. The aim of this study was to examine how the choice of foods of varying levels of healthfulness (less healthy, moderately healthy, and healthier) is affected by the appearance of various FoPLs (Daily Intake Guide, Multiple Traffic Lights, Health Star Rating) when shown in combination with different claim conditions (no claim, nutrient claim, general-level health claim, and higher-level health claim). Adults and children (n = 2069) completed a discrete-choice experiment online. Respondents were shown 8 choice sets, each containing 4 alternatives of the same food type (cookies, cornflakes, pizza, or yogurt) of varying levels of healthfulness and were asked which product they would likely purchase (or they could select none). Respondents were randomly assigned to view 1 of the 3 FoPLs across all choice sets. Claim type and healthfulness varied within choice sets in accordance with a D-efficient design. The probability of choosing a healthy product and avoiding an unhealthy product was greatest when only an FoPL (especially the Health Star Rating) appeared on-pack. The addition of a nutrient or health claim did not affect the likelihood of picking healthier products but did increase the likelihood of selecting less healthy foods across all FoPL conditions. FoPLs are most effective in helping consumers make better food choices when nutrient and health claims are not present. Policies are required to control how nutrient and health claims are applied to less healthy foods. This trial was registered as ACTRN12617000015347 (www.anzctr.org.au/Trial/Resgistration/TrialReview.aspx?id=372055&isReview=true).
Publisher: Cambridge University Press (CUP)
Date: 08-01-2018
DOI: 10.1017/S1368980017003731
Abstract: Measurement of mean population Na and K intakes typically uses laboratory-based assays, which can add significant logistical burden and costs. A valid field-based measurement method would be a significant advance. In the current study, we used 24 h urine s les to compare estimates of Na, K and Na:K ratio based upon assays done using the field-based Horiba twin meter v . laboratory-based methods. The performance of the Horiba twin meter was determined by comparing field-based estimates of mean Na and K against those obtained using laboratory-based methods. The reported 95 % limits of agreement of Bland–Altman plots were calculated based on a regression approach for non-uniform differences. The 24 h urine s les were collected as part of an ongoing study being done in rural China. One hundred and sixty-six complete 24 h urine s les were qualified for estimating 24 h urinary Na and K excretion. Mean Na and K excretion were estimated as 170·4 and 37·4 mmol/d, respectively, using the meter-based assays and 193·4 and 43·8 mmol/d, respectively, using the laboratory-based assays. There was excellent relative reliability (intraclass correlation coefficient) for both Na (0·986) and K (0·986). Bland–Altman plots showed moderate-to-good agreement between the two methods. Na and K intake estimations were moderately underestimated using assays based upon the Horiba twin meter. Compared with standard laboratory-based methods, the portable device was more practical and convenient.
Publisher: WHO Press
Date: 09-2009
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 29-09-2022
Abstract: KidneyIntelX, a bioprognostic test for assessing risk of CKD progression, risk stratified in iduals for kidney, heart failure, and death outcomes in the Canagliflozin Cardiovascular Assessment Study. In iduals scored as high risk seemed to derive more of benefit from treatment with canagliflozin versus placebo. These findings may serve to increase adoption of underutilized therapies for cardiorenal risk reduction in patients with diabetic kidney disease.
Publisher: Elsevier BV
Date: 07-2023
Publisher: Elsevier BV
Date: 12-2016
Publisher: Elsevier BV
Date: 06-2018
DOI: 10.1016/J.DIABRES.2018.03.027
Abstract: Sodium glucose co-transporter 2 (SGLT2) inhibitors appear to protect against increased risks of cardiovascular and kidney disease in patients with type 2 diabetes but also cause some harms. Whether effects are comparable across drug class or specific to in idual compounds is unclear. This meta-analysis assessed the class and in idual compound effects of SGLT2 inhibition versus control on cardiovascular events, death, kidney disease and safety outcomes in patients with type 2 diabetes. MEDLINE, EMBASE, the Cochrane Library and regulatory databases were systematically searched for data from randomized clinical trials that included reporting of cardiovascular events, deaths or safety outcomes. We used fixed effects models and inverse variance weighting to calculate relative risks with the 95% confidence intervals. The analyses included data from 82 trials, four overviews and six regulatory reports and there were 1,968 major cardiovascular events identified for analysis. Patients randomly assigned to SGLT2 had lower risks of major cardiovascular events (RR 0.85, 95%CI 0.77-0.93), heart failure (RR 0.67, 95%CI 0.55-0.80), all-cause death (RR 0.79, 95%CI 0.70-0.88) and serious decline in kidney function (RR 0.59, 0.49-0.71). Significant adverse effects were observed for genital infections (RR 3.06, 95%CI 2.73-4.43), volume depletion events (RR 1.24, 95%CI 1.07-1.43) and utation (RR 1.44 95%CI 1.13-1.83). There was a high likelihood of differences in the associations of the in idual compounds with cardiovascular death, hypoglycaemia and utation (all I There are strong overall associations of SGLT2 inhibition with protection against major cardiovascular events, heart failure, serious decline in kidney function and all-cause death. SGLT2 inhibitors were also associated with infections, volume depletion effects and utation. Some associations appear to differ between compounds.
Publisher: MDPI AG
Date: 16-02-2023
DOI: 10.3390/NU15040991
Abstract: From 2015 to 2020 a state-wide salt-reduction initiative was launched in Victoria, Australia, including an awareness c aign focused on parents with children years of age. To evaluate the impact of the c aign on salt-related knowledge, attitudes and behaviors (KABs) we have assessed trends in salt-related KAB pre- and post-delivery of the c aign in parents, as well as within the wider adult population. Cross-sectional surveys of adults aged 18–65 years were undertaken pre- (2015: n = 821 parents n = 1527 general s le) and post-c aign (2019: n = 935 parents n = 1747 general s le). KABs were assessed via an online survey. Data were analyzed with regression models and adjusted for covariates. Among parents, around one-quarter of salt-related KABs shifted in a positive direction, but changes were small: there was a 6% (95% CI 2, 11%) increase in the percentage who knew the main source of salt in the diet and reductions in the percentage who reported placing a salt shaker on the table (−8% (95%CI −12, −3)) and that their child added salt at the table (−5% (95% −9, −0.2)). Among the wider adult s le, even fewer shifts in KAB were observed, with some behaviors worsening at follow-up. These findings indicate that this consumer awareness c aign had minimum impact.
Publisher: Elsevier BV
Date: 05-2018
Publisher: Springer Science and Business Media LLC
Date: 04-2023
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2012
DOI: 10.1161/STROKEAHA.112.651448
Abstract: Observational studies demonstrate strong associations between blood pressure and bleeding complications of antithrombotic therapy. The objective was to determine whether blood pressure lowering reduces risks of bleeding in patients on antithrombotic therapy. This is a subsidiary analysis of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) trial, a randomized, placebo-controlled trial. A total of 6105 patients with cerebrovascular disease were randomly assigned to either active treatment (perindopril±indapamide) or placebo(s). The outcomes were intracranial and extracranial bleeding. There were 4876 (80%) patients on antithrombotic therapy at baseline. Over a mean follow-up of 3.9 years, 119 intracranial and 123 extracranial bleeding events were observed. Among patients with and without antithrombotic therapy, active treatment lowered blood pressure by 8.9/4.0 and 9.3/3.8 mm Hg and reduced the risks of intracranial bleeding by 46% (95% CI, 7%–69%) and 70% (39%–85%), respectively. However, active treatment did not reduce the risks of extracranial bleeding significantly in either group. Among patients on antithrombotic therapy, the lowest risk of intracranial bleeding was observed in participants with the lowest follow-up systolic blood pressure levels (median, 113 mm Hg). Blood pressure lowering provides protection against intracranial bleeding among patients with cerebrovascular disease including those receiving antithrombotic therapy. This trial was not registered because patients were enrolled before July 1, 2005.
Publisher: Elsevier BV
Date: 09-2023
Publisher: MDPI AG
Date: 21-12-2022
DOI: 10.3390/NU15010027
Abstract: Increased consumption of unhealthy processed foods, particularly those high in sodium, is a major risk factor for cardiovascular diseases. The nutrition information on packaged foods can help guide consumers toward products with less sodium and support government actions to improve the healthiness of the food supply. The aims of this study were to estimate the proportion of packaged foods displaying nutrition information for sodium and other nutrients specified by Nigerian nutrition labelling regulations and to determine the amount of sodium in packaged foods sold in Nigeria using data from the nutritional information panel. Data were collected from November 2020 to March 2021 from in-store surveys conducted in supermarkets in three states. A total of 7039 products were collected. Overall, 91.5% (n = 6439) provided only partial nutrition information, 7.0% (n = 495) provided no nutritional information, and only 1.5% (n = 105) displayed a nutrient declaration that included all nutrients specified by 2019 Nigerian regulations. Some form of sodium content information was displayed for 86% of all products (n = 6032), of which around 45% (n = 2689) expressed this as ‘salt’ and 59% (n = 3559) expressed this as ‘sodium’, while a small number of food products had both ‘salt’ and ‘sodium’ content (3.6%). Provision of sodium or salt information on the label varied between food categories, ranging from 50% (vitamins and supplements, n = 2/4) to 96% (convenience foods, n = 44/46). Food categories with the highest median sodium content were ‘meat and meat alternatives’ (904 mg/100 g), ‘sauces, dressings, spreads, and dips’ (560 mg/100 g), and ‘snack foods’ (536 mg/100 g), although wide variation was often observed within categories. These findings highlight considerable potential to improve the availability and consistency of nutrition information on packaged products in Nigeria and to introduce further policies to reduce the amount of sodium in the Nigerian food supply.
Publisher: AMPCo
Date: 08-2011
Publisher: Oxford University Press (OUP)
Date: 08-2003
Publisher: AMPCo
Date: 05-2005
DOI: 10.5694/J.1326-5377.2005.TB06801.X
Abstract: Patients with acute coronary syndromes represent a clinically erse group and their care remains heterogeneous. These patients account for a significant burden of morbidity and mortality in Australia. Optimal patient outcomes depend on rapid diagnosis, accurate risk stratification and the effective implementation of proven therapies, as advocated by clinical guidelines. The challenge is in effectively applying evidence in clinical practice. Objectivity and standardised quantification of clinical practice are essential in understanding the evidence-practice gap. Observational registries are key to understanding the link between evidence-based medicine, clinical practice and patient outcome. Data elements for monitoring clinical management of patients with acute coronary syndromes have been adapted from internationally accepted definitions and incorporated into the National Health Data Dictionary, the national standard for health data definitions in Australia. Widespread use of these data elements will assist in the local development of "quality-of-care" initiatives and performance indicators, facilitate collaboration in cardiovascular outcomes research, and aid in the development of electronic data collection methods.
Publisher: Springer Science and Business Media LLC
Date: 12-09-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2004
DOI: 10.1097/00004872-200403000-00030
Abstract: To assess the consistency of the benefits of blood pressure lowering on secondary stroke risk by age, sex and geographic region of recruitment. Randomized, placebo-controlled trial. Participants were randomized to the angiotensin-converting enzyme (ACE) inhibitor perindopril (plus the diuretic indapamide if not indicated or contraindicated) or to placebo(s) over a mean follow-up of 3.9 years. Main analyses used Cox proportional hazards models on an intention-to-treat basis. Subgroup results were standardized for the proportion (42%) taking single-drug therapy. A total of 172 centres in Asia, Australia, New Zealand and Europe. Patients (n = 6105) with a history of stroke or transient ischaemic attack, of whom 50% were aged over 65 years at baseline, 30% were women and 39% were from Asia. Stroke, coronary heart disease and major vascular events. Overall, treatment reduced stroke by 28% [95% confidence interval (CI) 17-38%] and major vascular events by 26% (16-44%), with separately significant reductions across subgroups defined by age ( or = 65 years), sex and region (Asia or not). Treatment was safe and well tolerated, and the absolute benefits were large 5 years' treatment would be expected to avert at least one major vascular event among every 20 patients in all age, sex and region subgroups. There was some evidence of particularly large benefits among younger participants and those from Asia. Blood pressure lowering reduces secondary stroke risk, with large absolute benefits across groups defined by age, sex and geographic region.
Publisher: Wiley
Date: 14-09-2020
DOI: 10.1111/DECI.12489
Abstract: Building upon social capital theory, we identify different attributes of frontline employee (FLE) social capital and outline how the use of online social networks (OSNs) can enable social capital development and social capital maintenance. We examine key boundary conditions of time management skills, perceived innovation climate, and customer perceived FLE responsiveness. Use of multi‐informant data from FLEs working in B2B sales/service roles, their customers, and managers enabled a comprehensive analysis that accounts for the endogenous nature of the predictor variables. We find the use of OSNs relates to social capital development and maintenance. Time management skills strengthen links between OSNs and both forms of social capital. However, perceived innovation climate plays a moderating role only in the social capital development process. Unique pathways connecting social capital development to customer loyalty with the firm and social capital maintenance to FLE sales performance were noted.
Publisher: Informa UK Limited
Date: 1999
DOI: 10.3109/10641969909061028
Abstract: The present Guidelines were prepared by the Guidelines Sub-Committee of the World Health Organization-International Society of Hypertension (WHO-ISH) Mild Hypertension Liaison Committee, the members of which are listed at the end of the text. These guidelines represent the fourth revision of the WHO-ISH Guidelines and were finalised after presentation and discussion at the 7th WHO-ISH Meeting on Hypertension, Fukuoka, Japan, 29th Sept-1st Oct, 1998. Previous versions of the Guidelines were published in Bull WHO 1993, 71:503-517 and J Hypertens 1993, 11:905-918.
Publisher: Elsevier BV
Date: 03-2009
Publisher: Oxford University Press (OUP)
Date: 09-2002
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2011
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 19-11-2020
DOI: 10.2215/CJN.10140620
Abstract: The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial demonstrated that the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin reduced the risk of kidney failure and cardiovascular events in participants with type 2 diabetes mellitus and CKD. Little is known about the use of SGLT2 inhibitors in patients with eGFR ml/min per 1.73 m 2 . The participants in the CREDENCE study had type 2 diabetes mellitus, a urinary albumin-creatinine ratio –5000 mg/g, and an eGFR of 30 to ml/min per 1.73 m 2 at screening. This post hoc analysis evaluated participants with eGFR ml/min per 1.73 m 2 at randomization. Effects of eGFR slope through week 130 were analyzed using a piecewise, linear, mixed-effects model. Efficacy was analyzed in the intention-to-treat population, on the basis of Cox proportional hazard models, and safety was analyzed in the on-treatment population. At randomization (an average of 29 days after screening), 174 of 4401 (4%) participants had an eGFR ml/min per 1.73 m 2 (mean [SD] eGFR, 26 [3] ml/min per 1.73 m 2 ). From weeks 3 to 130, there was a 66% difference in the mean rate of eGFR decline with canagliflozin versus placebo (mean slopes, −1.30 versus −3.83 ml/min per 1.73 m 2 per year difference, −2.54 ml/min per 1.73 m 2 per year 95% confidence interval [CI], 0.90 to 4.17). Effects of canagliflozin on kidney, cardiovascular, and mortality outcomes were consistent for those with eGFR and ≥30 ml/min per 1.73 m 2 (all P interaction .20). The estimate for kidney failure in participants with eGFR ml/min per 1.73 m 2 (hazard ratio, 0.67 95% CI, 0.35 to 1.27) was similar to those with eGFR ≥30 ml/min per 1.73 m 2 (hazard ratio, 0.70 95% CI, 0.54 to 0.91 P interaction=0.80). There was no imbalance in the rate of kidney-related adverse events or AKI associated with canagliflozin between participants with eGFR and ≥30 ml/min per 1.73 m 2 (all P interaction .12). This post hoc analysis suggests canagliflozin slowed progression of kidney disease, without increasing AKI, even in participants with eGFR ml/min per 1.73 m 2 .
Publisher: Elsevier BV
Date: 10-2022
DOI: 10.1016/J.AHJ.2022.06.007
Abstract: High dietary sodium intake is a leading cause of hypertension. A major source of dietary sodium is salt added to processed food products available in retail food environments. The fast-growing online grocery shopping setting provides new opportunities for salt reduction interventions that support consumers in choosing healthier options. The SaltSwitch Online Grocery Shopping randomized controlled trial is investigating the feasibility, acceptability, and effectiveness of a novel intervention for lowering salt consumption and blood pressure amongst people with hypertension who shop for groceries online. The intervention is based on a bespoke web browser extension that interfaces with a major retailer's online store to highlight and interpret product sodium content and suggest similar but lower-sodium alternatives. The primary outcome of interest is change in mean systolic blood pressure between in iduals randomized (1:1) to the intervention and control (usual online shopping) arms at 12 weeks. Secondary outcomes are diastolic blood pressure, spot urinary sodium and sodium:potassium ratio, sodium purchases, and dietary intake. Intervention implementation and lessons for future uptake will be assessed using a mixed methods process evaluation. Participants with hypertension who shop online for groceries and exhibit high sodium purchasing behavior are being recruited across Australia. A target s le size of 1,966 provides 80% power (2-sided alpha = 0.05) to detect a 2 mm Hg difference in systolic blood pressure between groups, assuming a 15 mm Hg standard deviation, after allowing for a 10% dropout rate. This trial will provide evidence on an innovative intervention to potentially reduce salt intake and blood pressure in people with hypertension. The intervention caters to in idual preferences by encouraging sustainable switches to similar but lower-salt products. If effective, the intervention will be readily scalable at low cost by interfacing with existing online retail environments.
Publisher: BMJ
Date: 2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 13-09-2005
DOI: 10.1161/CIRCULATIONAHA.104.501163
Abstract: Background— The prevalence of white matter hyperintensities (WMHs) detected on cerebral MRI is associated with hypertension, but it is not known whether blood pressure lowering can arrest their progression. We report here the results of an MRI substudy of PROGRESS (Perindopril Protection Against Recurrent Stroke Study), a randomized trial of blood pressure lowering in subjects with cerebrovascular disease. Methods and Results— The substudy comprised 192 participants who had a cerebral MRI both at baseline and after a mean follow-up time of 36 months (SD=6.0 months). At the first MRI, WMHs were graded with a visual rating scale from A (no WMH) to D (severe WMH). Participants were assigned to a combination of perindopril plus indapamide (or their placebos 58%) or to single therapy with perindopril (or placebo). At the time of the second MRI, the blood pressure reduction in the active arm compared with the placebo arm was 11.2 mm Hg for systolic blood pressure and 4.3 mm Hg for diastolic blood pressure. Twenty-four subjects (12.5%) developed new WMHs at follow-up. The risk of new WMH was reduced by 43% (95% CI −7% to 89%) in the active treatment group compared with the placebo group ( P =0.17). The mean total volume of new WMHs was significantly reduced in the active treatment group (0.4 mm 3 [SE=0.8]) compared with the placebo group (2.0 mm 3 [SE=0.7] P =0.012). This difference was greatest for patients with severe WMH at entry, 0.0 mm 3 (SE=0) in the active treatment group versus 7.6 mm 3 (SE=1.0) in the placebo group ( P .0001). Conclusions— These results indicate that an active blood pressure–lowering regimen stopped or delayed the progression of WMHs in patients with cerebrovascular disease.
Publisher: Elsevier BV
Date: 09-2001
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: Elsevier BV
Date: 07-2019
DOI: 10.1053/J.JRN.2018.10.009
Abstract: The objective of the study was to assess the impact of sustained dietary salt reduction on albuminuria in nearly 2000 community-dwelling adults. The present study is a prespecified secondary analysis of the China Rural Health Initiative Salt Reduction Study cluster randomized trial undertaken in 120 villages in rural China. Villages were randomized to a sodium reduction program of education and access to reduced-sodium salt substitute or control. Urinary albumin-to-creatinine ratio (uACR) and albuminuria (uACR ≥22.1 or 31.0 mg/g for men and women, respectively) were assessed at 18 months in a stratified random s le of predominantly older in iduals living in participating rural villages. A total of 2,566 participants from 119 villages provided 1,903 eligible urine s les. The sodium reduction program reduced sodium intake by an equivalent of 0.82g of salt/day (0.06-1.68 g) (322 [24-661] mg sodium/day). The mean uACR was 8.85 (8.05-9.82) mg/g (1.00 [0.91-1.11] mg/mmol) in intervention participants compared with 10.53 (9.73-11.33) mg/g (1.19 [1.10-1.28] mg/mmol) in control participants (p=0.008). The corresponding odds ratio for albuminuria was 0.67 (0.46-0.99). Dietary sodium reduction was associated with significantly lower uACR and less albuminuria after 18 months. Whether CKD progression can be slowed by dietary sodium reduction should be a global research priority. CLINICALTRIALS.GOV: NCT01259700.
Publisher: Elsevier BV
Date: 06-2009
DOI: 10.1016/J.JCLINEPI.2008.07.018
Abstract: To demonstrate how mixed models may be used to estimate treatment effects, and inform decisions on the need for monitoring initial response. Mixed models were used to analyze data from the Perindopril Protection Against Recurrent Stroke Study (PROGRESS), which examined the effects of perindopril and indapamide in 6,105 patients at high risk of a cerebrovascular event. The mean effect of perindopril was to lower blood pressure (BP) (systolic/diastolic) by 6/3 mmHg. The mean effects of perindopril/indapamide varied according to baseline BP, and lowering of BP ranged from 9/5 to 14/5 mmHg (for in iduals with a baseline systolic BP 150 mmHg, respectively). We found no variation in the effects of treatment on BP for either perindopril alone or in combination with indapamide. The effects of treatment on the in idual can be predicted from the mean effect of treatment for the group (perindopril) or baseline systolic BP subgroup (perindopril/indapamide). Monitoring initial treatment response is unnecessary for antihypertensives similar to those examined in this study. To address this issue for other therapies, we suggest that trials should report estimates of treatment effects from mixed models, and the CONSORT statement should be expanded to include this item.
Publisher: MDPI AG
Date: 24-11-2017
DOI: 10.3390/NU9121284
Publisher: BMJ
Date: 26-04-2010
Abstract: Little is known about the context, risk factors and severity of non-fatal fall-related injury in India. To report these data for a rural population in the East and West Godavari districts of the Indian state of Andhra Pradesh. In a cross-sectional population-based survey, 3686 participants aged >or=30 years (83.6% participation) selected by stratified random s ling were interviewed in 44 villages. Participants recalled injuries in the preceding 12 months that required them to stay away from their usual daily duties for at least 1 day irrespective of whether medical attention was sought for that injury. The annual incidence of non-fatal fall-related injury based on a 3-month recall period was 3.30% (95% CI 2.54% to 4.05%) and 9.22% (95% CI 7.74% to 10.69%) for men and women, respectively, with the incidence increasing with age. For the most recent non-fatal fall-related injury, the home was the most common place of injury for women, and the farm for men, with the former more likely to fall while climbing up/down (20.9%) compared with the latter (10.3%). Most falls were at the same level (71.7%) and slipping was the most common cause of fall (40%). Limbs (legs, 55% hand/arm, 33.3%) were the most commonly injured body part. Fifty-six per cent reported seeking treatment outside home for injury, of whom 74.6% were women and 8.4% reported being admitted to a hospital. Falls are a significant public health problem facing women in rural India. Fall prevention strategies should be explored and implemented within the Indian context.
Publisher: Springer Science and Business Media LLC
Date: 18-09-2014
Publisher: Elsevier BV
Date: 12-2012
Publisher: CMA Joule Inc.
Date: 16-04-2012
DOI: 10.1503/CMAJ.111895
Publisher: Elsevier BV
Date: 2013
Publisher: Elsevier BV
Date: 02-2022
DOI: 10.1016/J.JAND.2021.06.013
Abstract: The Australian Government will soon be releasing a series of sugar reformulation targets for packaged foods. To estimate the amount of added sugar purchased from packaged food and beverages and the relative contribution that food categories and food companies made to these purchases in 2018. The secondary objective was to examine differences in purchases of added sugar across income levels. Cross-sectional study. We used 1 year of grocery purchase data from a nationally representative panel of Australian households (the NielsenIQ Homescan panel), combined with a packaged food and beverage database (FoodSwitch). Added sugar purchases (grams per day per capita), purchase-weighted added sugar content (grams per 100 g) and total weight of products (with added sugar) purchased (grams per day per capita). Food categories and food companies were ranked according to their contribution to added sugar purchases. Differences in added sugar purchases by income levels were assessed by 1-factor analysis of variance. Added sugar information was available from 7188 households and across 26,291 unique foods and beverages. On average, the amount of added sugar acquired from packaged foods and beverages was (mean ± SE) 35.9 ± 0.01 g/d per capita. Low-income households purchased 11.0 g/d (95% CI: 10.9-11.0 g/d, P < .001) more added sugar from packaged products than high-income households per capita. The top 10 food categories accounted for 82.2% of added sugar purchased, largely due to purchases of chocolate and sweets, soft drinks, and ice cream and edible ices. Out of 994 food companies, the top 10 companies contributed to 62.1% of added sugar purchases. The Australian Government can strengthen their proposed sugar reduction program by adding further category-specific targets, prioritizing engagement with key food companies and considering a broader range of policies to reduce added sugar intakes across the Australian population.
Publisher: Elsevier BV
Date: 03-2012
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2017
Publisher: Elsevier BV
Date: 05-2015
Publisher: BMJ
Date: 12-2019
DOI: 10.1136/BMJGH-2019-001882
Abstract: Unhealthy diets are a leading cause of death and disability globally. The WHO recommends Member States implement front-of-pack (FOP) nutrition labels to guide consumers towards healthier food choices, as part of comprehensive strategies to prevent diet-related non-communicable diseases. Interest in FOP nutrition labelling is increasing, but there is limited guidance for policymakers developing regulations necessary for effective implementation. A rapidly evolving evidence base, limited regulatory capacity and possibility of legal challenge by affected food industry stakeholders can create ‘regulatory chill’, whereby governments are dissuaded from progressive public health policymaking. We use a framework for analysing public health law and available best-practice guidance to evaluate key components of 31 FOP nutrition labelling regulations endorsed by governments up to June 2019. Analysis of regulatory form shows recent rapid uptake of label formats that are easier for consumers to understand and increasing use of mandatory legislation. However, policymakers must decide much more than whether to apply ‘stars’, ‘traffic lights’ or ‘stop signs’. The substance of effective regulation must contain strategic regulatory objectives, clear specifications for displaying the label on pack, a valid scoring mechanism and a justified scope for including foods. While there are limited data on current practice, good governance of FOP nutrition labelling regulation also requires transparency and accountability in processes of label development, implementation, evaluation and enforcement to promote continuous improvement and withstand undue commercial interference. Whether developing new FOP nutrition labels or reforming existing ones, our findings support policymakers to design and implement best-practice, evidence-informed regulation.
Publisher: Elsevier BV
Date: 03-2017
Publisher: Springer Science and Business Media LLC
Date: 23-09-2022
DOI: 10.1186/S12933-022-01619-0
Abstract: Sodium glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of kidney and heart failure events independent of glycemic effects. We assessed whether initiation of the SGLT2 inhibitor canagliflozin guided by multivariable predicted risk based on clinical characteristics and novel biomarkers is more efficient to prevent clinical outcomes compared to a strategy guided by HbA1c or urinary-albumin-creatinine ratio (UACR) alone. We performed a post-hoc analysis of the CANVAS trial including 3713 patients with available biomarker measurements. We compared the number of composite kidney (defined as a sustained 40% decline in eGFR, chronic dialysis, kidney transplantation, or kidney death) and composite heart failure outcomes (defined as heart failure hospitalization or cardiovascular (CV) death) prevented per 1000 patients treated for 5 years when canagliflozin was initiated in patients according to HbA1c ≥ 7.5%, UACR, or multivariable risk models consisting of: (1) clinical characteristics, or (2) clinical characteristics and novel biomarkers. Differences in the rates of events prevented between strategies were tested by Chi 2 -statistic. After a median follow-up of 6.1 years, 144 kidney events were recorded. The final clinical model included age, previous history of CV disease, systolic blood pressure, UACR, hemoglobin, body weight, albumin, estimated glomerular filtration rate, and randomized treatment assignment. The combined biomarkers model included all clinical characteristics, tumor necrosis factor receptor-1, kidney injury molecule-1, matrix metallopeptidase-7 and interleukin-6. Treating all patients with HbA1c ≥ 7.5% (n = 2809) would prevent 33.0 (95% CI 18.8 to 43.3 ) kidney events at a rate of 9.6 (95% CI 5.5 to 12.6) events prevented per 1000 patients treated for 5 years. The corresponding rates were 5.8 (95% CI 3.4 to 7.9), 16.6 (95% CI 9.5 to 22.0) (P 0.001 versus HbA1c or UACR approach), and 17.5 (95% CI 10.0 to 23.0) (P 0.001 versus HbA1c or UACR approach P = 0.54 versus clinical model). Findings were similar for the heart failure outcome. Initiation of canagliflozin based on an estimated risk-based approach prevented more kidney and heart failure outcomes compared to a strategy based on HbA1c or UACR alone. There was no apparent gain from adding novel biomarkers to the clinical risk model. These findings support the use of risk-based assessment using clinical markers to guide initiation of SGLT2 inhibitors in patients with type 2 diabetes.
Publisher: American Medical Association (AMA)
Date: 10-02-2015
Abstract: Lowering blood pressure (BP) is widely used to reduce vascular risk in in iduals with diabetes. To determine the associations between BP-lowering treatment and vascular disease in type 2 diabetes. We searched MEDLINE for large-scale randomized controlled trials of BP-lowering treatment including patients with diabetes, published between January 1966 and October 2014. Two reviewers independently extracted study characteristics and vascular outcome data. Estimates were stratified by baseline BP and achieved BP, and pooled using fixed-effects meta-analysis. All-cause mortality, cardiovascular events, coronary heart disease events, stroke, heart failure, retinopathy, new or worsening albuminuria, and renal failure. Forty trials judged to be of low risk of bias (100,354 participants) were included. Each 10-mm Hg lower systolic BP was associated with a significantly lower risk of mortality (relative risk [RR], 0.87 95% CI, 0.78-0.96) absolute risk reduction (ARR) in events per 1000 patient-years (3.16 95% CI, 0.90-5.22), cardiovascular events (RR, 0.89 [95% CI, 0.83-0.95] ARR, 3.90 [95% CI, 1.57-6.06]), coronary heart disease (RR, 0.88 [95% CI, 0.80-0.98] ARR, 1.81 [95% CI, 0.35-3.11]), stroke (RR, 0.73 [95% CI, 0.64-0.83] ARR, 4.06 [95% CI, 2.53-5.40]), albuminuria (RR, 0.83 [95% CI, 0.79-0.87] ARR, 9.33 [95% CI, 7.13-11.37]), and retinopathy (RR, 0.87 [95% CI, 0.76-0.99] ARR, 2.23 [95% CI, 0.15-4.04]). When trials were stratified by mean baseline systolic BP at greater than or less than 140 mm Hg, RRs for outcomes other than stroke, retinopathy, and renal failure were lower in studies with greater baseline systolic BP (P interaction <0.1). The associations between BP-lowering treatments and outcomes were not significantly different, irrespective of drug class, except for stroke and heart failure. Estimates were similar when all trials, regardless of risk of bias, were included. Among patients with type 2 diabetes, BP lowering was associated with improved mortality and other clinical outcomes with lower RRs observed among those with baseline BP of 140 mm Hg and greater. These findings support the use of medications for BP lowering in these patients.
Publisher: BMJ
Date: 08-09-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2010
DOI: 10.1161/HYPERTENSIONAHA.109.140624
Abstract: There is considerable uncertainty regarding the efficacy of blood pressure–lowering therapy in reducing cardiovascular risk in obese people. In this report we examine the effects of blood pressure lowering according to baseline body mass index (kilograms per meter squared) in the Perindopril Protection Against Recurrent Stroke Study. A total of 6105 participants with cerebrovascular disease were randomized to perindopril-based blood pressure–lowering therapy or placebo. The overall mean difference in systolic/diastolic blood pressure between participants assigned active therapy or placebo was 9/4 mm Hg (SE: 0.5/0.3 mm Hg), with no difference by body mass index quarters ( .1, 23.1 to 25.3, 25.4 to 27.8, and ≥27.9 kg/m 2 ). A consistent treatment benefit was demonstrated for protection against major vascular events across quarters with the following hazard ratios (95% CIs): 0.80 (0.62 to 1.02), 0.78 (0.61 to 1.01), 0.67 (0.53 to 0.86), 0.69 (0.54 to 0.88), and 0.74 (0.66 to 0.84 P for heterogeneity=0.16). Similar results were apparent for stroke and stroke subtypes (all P for heterogeneity ≥0.07) or with the standard definitions of overweight and obesity ( , 25 to 29, and ≥30 kg/m 2 all P for heterogeneity ≥0.28). The absolute effects of treatment were, however, more than twice that in the highest compared with the lowest body mass index quartile. Across increasing quarters of body mass index over 5 years, active therapy prevented 1 major vascular event among every 28, 23, 13, and 13 patients treated. In conclusion, blood pressure–lowering therapy produced comparable risk reductions in vascular disease across the whole range of body mass indices in participants with a history of stroke. However, the greater baseline level of cardiovascular risk in those with higher body mass index meant that these patients obtained the greatest benefit.
Publisher: BMJ
Date: 02-08-2006
Publisher: BMJ
Date: 14-05-2014
Abstract: There is ongoing controversy regarding a 'J-curve' phenomenon such that low and high blood pressure (BP) levels are associated with increased risks of recurrent stroke. We aimed to determine whether large treatment-related BP reductions are associated with increased risks of recurrent stroke. Data are from the PROGRESS trial, where 6105 patients with cerebrovascular disease were randomly assigned to either active treatment (perindopril ± indapamide) or placebo(s). There were no BP criteria for entry. BP was measured at every visit, and participant groups defined by reduction in systolic BP (SBP) from baseline were used for the analyses. Outcome was recurrent stroke. During a mean follow-up of 3.9 years, 727 recurrent strokes were observed. There were clear associations between the magnitude of SBP reduction and the risk of recurrent stroke. After adjustment for cardiovascular risk factors and randomised treatment, annual incidence was 2.08%, 2.10%, 2.31% and 2.96% for participant groups defined by SBP reductions of ≥ 20, 10-19, 0-9 and <0 mm Hg, respectively (p=0.0006 for trend). The present analysis provided no evidence of an increase in recurrent stroke associated with larger reductions in SBP produced by treatment among patients with cerebrovascular disease.
Publisher: Wiley
Date: 25-01-2017
DOI: 10.1111/DOM.12829
Publisher: Elsevier BV
Date: 10-2022
DOI: 10.1016/J.HFC.2022.03.008
Abstract: Sodium glucose cotransporter 2 (SGLT2) inhibitors are associated with cardiovascular and renal benefits across a broad range of patients, with no increase in total serious adverse events. We evaluated the evidence with respect to utation and fracture risks for this drug class. Overall, SGLT2 inhibitors are not associated with an increased risk of utation or fracture in any of the patient populations they have been tested in. The increase in utation and fracture risks with canagliflozin observed in the CANagliflozin cardioVascular Assessment Study (CANVAS) program was not seen in the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation trial or any study of other SGLT2 inhibitors. Extensive evaluation of utation and fracture risks suggests that the CANVAS program findings were chance observations rather than real effects.
Publisher: BMJ
Date: 05-2018
Publisher: Wiley
Date: 06-12-2001
DOI: 10.1046/J.1440-1681.2001.03581.X
Abstract: 1. Diabetes is a major global public health problem. The prevalence of this disease is predicted to increase sharply in the coming decades, particularly in less-developed regions of the world. 2. Most premature morbidity and mortality associated with diabetes relates to markedly increased risks of major cardiovascular diseases, such as myocardial infarction and stroke (macrovascular events), as well as microvascular complications, such as nephropathy and retinopathy. 3. Hypertension is a prevalent and important risk factor for vascular events in these patients. However, observational data demonstrate a continuous relationship between blood pressure and risk of vascular events, suggesting that even those in iduals considered normotensive may benefit from blood pressure lowering. 4. Trials of blood pressure lowering among mostly hypertensive in iduals with diabetes have demonstrated benefit of intervention on macrovascular and microvascular outcomes. Recent data may suggest additional effects of angiotensin- converting enzyme inhibitors independent of blood pressure lowering. 5. Issues where data are lacking with respect to blood pressure lowering in diabetes include the effects of blood pressure lowering among non-hypertensive in iduals and the effects of blood pressure lowering regimens based on different classes of drug. 6. Data expected to address some of these issues are being collected. These include a prospective meta-analysis of blood pressure-lowering trials with large numbers of patients with diabetes. A new large-scale randomised trial, ADVANCE (Action in Diabetes and Vascular Disease), is also described.
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: JMIR Publications Inc.
Date: 21-08-2014
DOI: 10.2196/MHEALTH.3230
Publisher: Wiley
Date: 03-01-2020
DOI: 10.1111/DOM.13920
Publisher: SAGE Publications
Date: 10-2023
Publisher: American Diabetes Association
Date: 07-2006
DOI: 10.2337/DC06-0621
Publisher: Elsevier BV
Date: 07-2019
Publisher: Oxford University Press (OUP)
Date: 28-02-2011
Abstract: Existing cardiovascular risk prediction equations perform non-optimally in different populations with diabetes. Thus, there is a continuing need to develop new equations that will reliably estimate cardiovascular disease (CVD) risk and offer flexibility for adaptation in various settings. This report presents a contemporary model for predicting cardiovascular risk in people with type 2 diabetes mellitus. A 4.5-year follow-up of the Action in Diabetes and Vascular disease: preterax and diamicron-MR controlled evaluation (ADVANCE) cohort was used to estimate coefficients for significant predictors of CVD using Cox models. Similar Cox models were used to fit the 4-year risk of CVD in 7168 participants without previous CVD. The model's applicability was tested on the same s le and another dataset. A total of 473 major cardiovascular events were recorded during follow-up. Age at diagnosis, known duration of diabetes, sex, pulse pressure, treated hypertension, atrial fibrillation, retinopathy, HbA1c, urinary albumin/creatinine ratio and non-HDL cholesterol at baseline were significant predictors of cardiovascular events. The model developed using these predictors displayed an acceptable discrimination (c-statistic: 0.70) and good calibration during internal validation. The external applicability of the model was tested on an independent cohort of in iduals with type 2 diabetes, where similar discrimination was demonstrated (c-statistic: 0.69). Major cardiovascular events in contemporary populations with type 2 diabetes can be predicted on the basis of routinely measured clinical and biological variables. The model presented here can be used to quantify risk and guide the intensity of treatment in people with diabetes.
Publisher: Elsevier BV
Date: 05-2016
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2009
DOI: 10.1161/STROKEAHA.108.539601
Abstract: Background and Purpose— End point adjudication committees (EPAC) are widely used in large-scale clinical trials to ensure the robustness of diagnosis for end points. Methods— The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) was a double-blind randomized trial of blood pressure lowering in 6105 participants with pre-existing cerebrovascular disease. Separate estimates of the effects of randomized treatment were determined using Cox regression models that were based on the unadjudicated events initially reported by the investigator and on the final events assigned by the EPAC. Results— There were 992 strokes initially reported by the investigators and 894 (90%) retained these diagnoses after adjudication by the EPAC. The hazard ratios (95% CIs) for the effect of randomized treatment on stroke were 0.74 (0.64 to 0.85) based on the investigator diagnoses and 0.72 (0.62 to 0.83) based on the EPAC diagnoses ( P homogeneity=0.7). For each stroke subtype reported, the corresponding numbers of diagnoses (investigators/EPAC) were ischemic (593/565), hemorrhagic (124/111), and unknown (124/93) with no impact of the EPAC review on the estimates of treatment effects (all P homogeneity .3). There was likewise no detectable effect of reclassification of diagnoses for the effect estimates calculated for myocardial infarction or the main causes of death (all P homogeneity .5). Conclusion— The EPAC process had no discernible impact on the trial conclusions. Very large trials powered to detect effects on stroke subtypes might obtain real scientific gain from an EPAC, but in the case of PROGRESS, the value of the EPAC was in the reassurance it provided.
Publisher: American Medical Association (AMA)
Date: 2006
DOI: 10.1001/ARCHNEUR.63.1.NOC50221
Abstract: Patients with stroke or transient ischemic attack are at high risk of another stroke, and there is need for improved strategies to predict recurrent stroke. To assess the prognostic value of levels of soluble vascular cell adhesion molecule 1 (sVCAM-1), N-terminal pro-B-type natriuretic peptide (NT-proBNP), C-reactive protein, homocysteine, renin, and lipids and lipoprotein particle concentration and size in patients with previous stroke or transient ischemic attack. A nested case-control study of participants of the Perindopril Protection Against Recurrent Stroke Study was performed. The Perindopril Protection Against Recurrent Stroke Study was a placebo-controlled trial of a perindopril erbumine-based, blood pressure-lowering regimen that reduced ischemic stroke risk by 24% among in iduals with previous stroke or transient ischemic attack. Each of 252 patients who experienced ischemic stroke during a mean follow-up of 3.9 years was matched to 1 to 3 control patients. Matching variables were age, sex, treatment allocated, region, and most recent qualifying event at randomization. Risk of ischemic stroke predicted by baseline levels of sVCAM-1, NT-proBNP, C-reactive protein, homocysteine, renin, and lipids and lipoprotein particle concentration and size. Levels of sVCAM-1 and NT-proBNP predicted recurrent ischemic stroke. The odds ratio for patients in the highest, as compared with the lowest, quarter was 2.24 (95% confidence interval, 1.35-3.73) for sVCAM-1 level and 1.62 (95% confidence interval, 0.98-2.69) for NT-proBNP level, after adjustment for matching and other risk factors. Patients in the highest quarters for both sVCAM-1 and NT-proBNP levels had 3.6 times the risk of recurrent ischemic stroke compared with patients in the lowest quarters for both biologic markers. Level of sVCAM-1 was similarly predictive of ischemic stroke in patients allocated to placebo and perindopril-based therapy. Baseline plasma levels of C-reactive protein, homocysteine, renin, and lipids and lipoprotein particle concentration and size did not predict recurrent ischemic stroke risk. Measurement of sVCAM-1 and NT-proBNP levels provides prognostic information for recurrent ischemic stroke beyond traditional risk factors.
Publisher: JMIR Publications Inc.
Date: 13-09-2010
DOI: 10.2196/JMIR.1364
Publisher: SAGE Publications
Date: 02-2008
Abstract: Purpose The use of centralized systems to adjudicate clinical events is common in large clinical trials, in spite of relatively little published literature concerning the rationale and justification. The purpose of this manuscript is to review the reasons for central adjudication and to discuss whether trials could be simplified by limiting or streamlining the adjudication process. Methods We reviewed the literature concerning central adjudication and documented the experience of adjudication in several clinical trials. Since definitions for nonfatal events are generally heterogeneous and subjective, one reason for a central process of adjudication is to assist in assuring systematic application of the definition used in the trial. In open-label trials, assuring that the adjudication is done blinded to treatment assignment may provide protection against differential misclassification. Regulatory authorities, including the FDA, derive confidence in the validity of results when central adjudication is performed. The clinical community has become accustomed to a certain amount of adjudication and may criticize trials that lack adjudication. Limitations It is difficult to document the value of adjudication in trials that have reported adjudicated and nonadjudicated event rates and related treatment effects. Making rationale decisions about when and how to adjudicate is h ered by the lack of published study of when and how central adjudication is helpful to improve the quality and validity of trials and at what cost. Conclusions Adjudication has not been shown to improve the ability to determine treatment effects. Thus, adjudication may be overly complex and overused in many large simple trials. The appropriate role of central adjudication — which trials, which outcomes, what methods — deserves scrutiny and further study. Clinical Trials 2008 5: 56—60. ctj.sagepub.com
Publisher: Elsevier BV
Date: 11-2003
DOI: 10.1016/S0140-6736(03)14739-3
Abstract: The benefits of reducing blood pressure on the risks of major cardiovascular disease are well established, but uncertainty remains about the comparative effects of different blood-pressure-lowering regimens. We aimed to estimate effects of strategies based on different drug classes (angiotensin-converting-enzyme [ACE] inhibitors, calcium antagonists, angiotensin-receptor blockers [ARBs], and diuretics or beta blockers) or those targeting different blood pressure goals, on the risks of major cardiovascular events and death. We did seven sets of prospectively-designed overviews with data from 29 randomised trials (n=162341). The trial eligibility criteria, primary outcomes, and main hypotheses were specified before the result of any contributing trial was known. In placebo-controlled trials the relative risks of total major cardiovascular events were reduced by regimens based on ACE inhibitors (22% 95% CI 17-27) or calcium antagonists (18% 5-29). Greater risk reductions were produced by regimens that targeted lower blood pressure goals (15% 5-24). ARB-based regimens reduced the risks of total major cardiovascular events (10% 4-17) compared with control regimens. There were no significant differences in total major cardiovascular events between regimens based on ACE inhibitors, calcium antagonists, or diuretics or beta blockers, although ACE-inhibitor-based regimens reduced blood pressure less. There was evidence of some differences between active regimens in their effects on cause-specific outcomes. For every outcome other than heart failure, the difference between randomised groups in achieved blood pressure reduction was directly related to the observed difference in risk. Treatment with any commonly-used regimen reduces the risk of total major cardiovascular events, and larger reductions in blood pressure produce larger reductions in risk.
Publisher: American Medical Association (AMA)
Date: 03-10-2016
Publisher: JMIR Publications Inc.
Date: 19-10-2022
Abstract: ven modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. ur aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI −331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI −1083 to 1347) mg for urinary potassium excretion, −0.66 (95% CI −3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI −21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. n this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19–related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. ustralian New Zealand Clinical Trials Registry ACTRN12619000352101 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471
Publisher: Public Library of Science (PLoS)
Date: 09-09-2022
DOI: 10.1371/JOURNAL.PONE.0269021
Abstract: Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including targeted direct funding and industry tax rebates. The effectiveness of the different approaches employed is unclear. To systematically review the effects of direct government financing interventions by allowing companies to reduce their tax payable on clinical trial activity. Pub Med, Scopus, Sage, ProQuest, Google Scholar and Google were searched up to the 11 th of April 2022. In addition, the reference lists of all potentially eligible documents were hand searched to identify additional reports. Following feedback from co-authors, information on a small number of additional interventions were specifically sought out and included. Summary information about potentially eligible reports were reviewed independently by two researchers, followed by extraction of data into a structured spreadsheet for eligible studies. The primary outcomes of interest were the number of clinical trials and the expenditure on clinical trials but data about other evaluations were also collected. There were 1694 potentially eligible reports that were reviewed. Full text assessments were done for 304, and 30 reports that provided data on 43 interventions were included– 29 that deployed targeted direct funding and 14 that provided tax rebates or exemptions. There were data describing effects on a primary outcome for 25/41 of the interventions. The most common types of interventions were direct funding to researchers via special granting mechanisms and tax offsets to companies and research organisations. All 25 of the studies for which data were available reported a positive impact on numbers and/or expenditure on clinical trials though the robustness of evaluations was limited for many. Estimates of the magnitude of effects of interventions were reported inconsistently, varied substantially, and could not be synthesised quantitatively, though targeted direct funding interventions appeared to be associated with more immediate impact on clinical trial activity. There is a high likelihood that governments can increase clinical trial activity with either direct or indirect fiscal mechanisms. Direct funding may provide a more immediate and tangible return on investment than tax rebates.
Publisher: Edward Elgar Publishing
Date: 22-02-2019
Publisher: Elsevier BV
Date: 07-2021
DOI: 10.1093/AJCN/NQAB054
Publisher: Public Library of Science (PLoS)
Date: 10-08-2016
Publisher: SAGE Publications
Date: 12-2017
DOI: 10.1509/JMR.14.0182
Abstract: Franchisors’ long-term viability is tied to the ongoing operations of their franchisees. To ensure the ongoing performance of franchisees, franchisors deploy multiple governance mechanisms. This study assesses how governance mechanisms deployed to enhance franchisee ability (via selection and socialization) and motivation (via incentives and monitoring) impact franchisee bankruptcy. The authors examine the in idual and joint effects of deploying governance mechanisms that share the same underlying objective, namely, to enhance franchisee ability and motivation. They also assess how motivation-inducing mechanisms may serve to counter the motivation-d ening effect of an increased royalty rate. Relying on data from multiple archival sources, the authors identify all bankruptcy filings by franchisees and their franchisors across 1,115 franchise systems over a 13-year observation window. Their findings document a positive and significant relationship between franchisee and franchisor bankruptcy. They also find main and interaction effects of the ability- and motivation-influencing governance mechanisms on the likelihood of franchisee bankruptcy, and the existence of significant bankruptcy spillovers among franchisees within the same franchise system. They discuss implications for franchise theory and management.
Publisher: Wiley
Date: 12-08-2018
DOI: 10.1111/JCH.13353
Publisher: Oxford University Press (OUP)
Date: 21-02-2012
DOI: 10.1093/NDT/GFS022
Abstract: Diabetes and chronic kidney disease (CKD) are both associated with an increased risk of cancer but it is unclear whether diabetes complicated by CKD further augments an in idual's cancer risk. The aim of our study was to determine the association of CKD [defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min] with the overall and site-specific risks of incident cancers among in iduals with Type 2 diabetes. Cox proportional hazard regression models and competing risk analyses were used to examine the univariate and multivariate adjusted associations between reduced kidney function and the overall and site-specific risks of cancer in participants enrolled in the Action in Diabetes and Vascular disease: Preterax and Diamicron MR controlled evaluation (ADVANCE) trial. Over a median follow-up of 5.0 years, 700 malignant neoplasms occurred in the 11 140 (6.4%) participants. There was no increase in overall cancer risk [adjusted hazard ratio: 1.07 (95% confidence interval: 0.89-1.29, P = 0.50)] or site-specific cancer risk for in iduals with CKD (defined as eGFR < 60 mL/min) compared to those without CKD at baseline. These results were robust to multiple methods and thresholds used to estimate CKD. Mild to moderate CKD does not increase the risk of cancer in people with Type 2 diabetes. ADVANCE is registered with ClincalTrial.gov (number NCT00145925).
Publisher: Wiley
Date: 24-08-2020
DOI: 10.1111/DOM.14143
Publisher: Springer Science and Business Media LLC
Date: 04-08-2011
Publisher: Wiley
Date: 16-04-2021
DOI: 10.1111/DOM.14386
Abstract: Heart failure is prevalent in those with type 2 diabetes and chronic kidney disease, and is associated with significant mortality and morbidity. In the CREDENCE trial, canagliflozin reduced the risk of hospitalization for heart failure (HHF) or cardiovascular (CV) death by 31%. In the current analysis we sought to determine whether the effect of canagliflozin on HHF/CV death differed in subgroups defined by key baseline participant characteristics. Cox regression models were used to estimate hazard ratios and 95% confidence intervals. Canagliflozin was associated with a reduction in the relative risk of HHF/CV death regardless of age, sex, history of heart failure or CV disease, and the use of loop diuretics or glucagon‐like peptide‐1 receptor agonists (all p interaction .114). The absolute benefit of canagliflozin was greater in those at highest baseline risk, such as those with CV disease (50 fewer events/1000 patients treated over 2.5 years vs. 20 fewer events in those without CV disease) or advanced kidney disease (estimated glomerular filtration rate [eGFR] 30–45 mL/min/1.73m 2 : 61 events prevented/1000 patients treated over 2.5 years vs. 23 events in eGFR 60–90 mL/min/1.73m 2 ). Canagliflozin consistently reduces the proportional risk of HHF/CV death across a broad range of subgroups with greater absolute benefits in those at highest baseline risk.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2004
DOI: 10.1161/01.STR.0000106480.76217.6F
Abstract: Background and Purpose— The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) showed that blood pressure lowering reduced stroke risk in patients with a history of cerebrovascular events. Here, we report the consistency of treatment effects across different stroke subtypes and among major clinical subgroups. Methods— PROGRESS was a randomized, double-blind trial among 6105 people with a prior history of cerebrovascular events. Participants were assigned to active treatment (perindopril for all participants and indapamide for those with neither an indication for nor a contraindication to a diuretic) or matching placebo(s). Results— During a mean of 3.9 years of follow-up, active treatment reduced the absolute rates of ischemic stroke from 10% to 8% (relative risk reduction [RRR], 24% 95% confidence interval [CI], 10 to 35) and the absolute rates of intracerebral hemorrhage from 2% to 1% (RRR, 50% 95% CI, 26 to 67). The relative risk of any stroke during follow-up was reduced by 26% (95% CI, 12 to 38) among patients whose baseline cerebrovascular event was an ischemic stroke and by 49% (95% CI, 18 to 68) among those whose baseline event was an intracerebral hemorrhage. There was no evidence that treatment effects were modified by other drug therapies (antiplatelet or other antihypertensive agents), residual neurological signs, atrial fibrillation, or the time since the last cerebrovascular event. Conclusions— Beneficial effects of a perindopril-based treatment regimen were observed for all stroke types and all major clinical subgroups studied. These data suggest that effective blood pressure–lowering therapy should be routinely considered for all patients with a history of cerebrovascular events.
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-02-2008
DOI: 10.1212/01.WNL.0000308819.43401.87
Abstract: The apolipoprotein E (APOE) polymorphism is an established risk factor for intracerebral hemorrhage (ICH) that is related to cerebral amyloid angiopathy in the white population. Among Asian populations, although ICH represents up to one third of all strokes and has high rates of mortality and morbidity, the role of the APOE polymorphism has not been well studied. The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) was a randomized, double-blind, placebo-controlled trial of a blood pressure lowering regimen in subjects with prior cerebrovascular disease. APOE status was determined for 5,671 patients, including 2,148 Asians (38%). During the 3.9 years of follow-up, ICH occurred in 99 patients. Overall, carrying an epsilon 2 or epsilon 4 allele of the APOE polymorphism was associated with an adjusted hazard ratio (HR(a)) of 1.85 (95% CI = 1.24 to 2.76). In Asian patients the risk of ICH for epsilon 2 or epsilon 4 carriers was 2.11 (95% CI = 1.28 to 3.47) and 1.48 (95% CI = 0.76 to 2.87) in Europeans. Carriers of the epsilon 2 or epsilon 4 allele had an increased risk of both incident and recurrent ICH, and both cortical and deep ICH, and most risk estimates were higher in Asians than in Europeans. For both ethnic groups and for subtypes of ICH active treatment more than halved the risk of ICH and the treatment effects were not different in carriers of the epsilon 2 or epsilon 4 allele and in those with the epsilon 3 epsilon 3 genotype. There is a strong association between APOE genotype and the risk of intracerebral hemorrhage (ICH). In Asian patients the role of APOE polymorphisms in ICH is much broader than was previously supposed.
Publisher: MDPI AG
Date: 31-05-2018
DOI: 10.3390/NU10060702
Publisher: Springer Science and Business Media LLC
Date: 05-08-2009
DOI: 10.1007/S00125-009-1470-0
Abstract: Improved glucose control in type 2 diabetes is known to reduce the risk of microvascular events. There is, however, continuing uncertainty about its impact on macrovascular disease. The aim of these analyses was to generate more precise estimates of the effects of more-intensive, compared with less-intensive, glucose control on the risk of major cardiovascular events amongst patients with type 2 diabetes. A prospectively planned group-level meta-analysis in which characteristics of trials to be included, outcomes of interest, analyses and subgroup definitions were all pre-specified. A total of 27,049 participants and 2,370 major vascular events contributed to the meta-analyses. Allocation to more-intensive, compared with less-intensive, glucose control reduced the risk of major cardiovascular events by 9% (HR 0.91, 95% CI 0.84-0.99), primarily because of a 15% reduced risk of myocardial infarction (HR 0.85, 95% CI 0.76-0.94). Mortality was not decreased, with non-significant HRs of 1.04 for all-cause mortality (95% CI 0.90-1.20) and 1.10 for cardiovascular death (95% CI 0.84-1.42). Intensively treated participants had significantly more major hypoglycaemic events (HR 2.48, 95% CI 1.91-3.21). Exploratory subgroup analyses suggested the possibility of a differential effect for major cardiovascular events in participants with and without macrovascular disease (HR 1.00, 95% CI 0.89-1.13, vs HR 0.84, 95% CI 0.74-0.94, respectively interaction p = 0.04). Targeting more-intensive glucose lowering modestly reduced major macrovascular events and increased major hypoglycaemia over 4.4 years in persons with type 2 diabetes. The analyses suggest that glucose-lowering regimens should be tailored to the in idual.
Publisher: Oxford University Press (OUP)
Date: 20-06-2017
Abstract: Background SaltSwitch is an innovative smartphone application (app) that enables shoppers to scan the barcode of a packaged food and receive an immediate, interpretive, traffic light nutrition label on the screen, along with suggestions for lower salt alternatives. Our aim was to determine the effectiveness of SaltSwitch to support people with cardiovascular disease to make lower salt food choices. Design Six-week, two-arm, parallel, randomised controlled trial in Auckland, New Zealand (2 weeks baseline and 4 weeks intervention). Methods Sixty-six adults with diagnosed cardiovascular disease (mean (SD) age 64 (7) years) were randomly assigned in a 1:1 ratio to either the SaltSwitch smartphone app or control (usual care). The primary outcome was the salt content of household packaged food purchases during the 4-week intervention (g/MJ). Secondary outcomes were the saturated fat content (g/MJ), energy content (kJ/kg) and expenditure (NZ$) of household food purchases systolic blood pressure (mmHg), urinary sodium (mg) and use and acceptability of the SaltSwitch app. Results Thirty-three participants with cardiovascular disease were allocated to the SaltSwitch intervention, and 33 to the control group. A significant reduction in mean household purchases of salt was observed (mean difference (95% confidence interval), -0.30 (-0.58 to -0.03) g/MJ), equating to a reduction of ∼0.7 g of salt per person per day during the 4-week intervention phase. There were no significant between-group differences in any secondary outcomes (all P > 0.05). Conclusions The SaltSwitch smartphone app is effective in supporting people with cardiovascular disease to make lower salt food purchases. A larger trial with longer follow-up is warranted to determine the effects on blood pressure. Trial registration Australian New Zealand Clinical Trials Registry www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365784&isReview=true ACTRN12614000206628.
Publisher: SAGE Publications
Date: 26-07-2016
Abstract: Sales competitions provide students with opportunities to apply their understanding of sales. Despite a long tradition of scholarship on sales role-plays, the answer to what drives student performance in sales competitions remains elusive. In this research, we examine how motivation (work engagement) and ability (cognitive aptitude and selling-related knowledge) affect student performance in sales role-play competitions. We also examine how success in sales role-plays engenders job attainment for the students. Using data from a sales competition held at a large public university in the United States, we provide empirical evidence that both motivation and ability affect sales performance. But, contrary to expectation, they have a substitution effect and not a complementary one. We also find evidence that success in sales role-plays translates into improved success in job interviews and that this effect is stronger for students with greater cognitive aptitude, that is, sales role-play performance complements the cognitive aptitude of the student to improve their mock interview performance.
Publisher: Oxford University Press (OUP)
Date: 10-07-2016
Abstract: The aim of this study was to investigate whether polypill-based care for the prevention of cardiovascular disease (CVD) is associated with a change in lifestyle risk factors when compared with usual care, among patients with CVD or high calculated cardiovascular risk. We conducted an in idual participant data meta-analysis of three trials including patients from Australia, England, India, Ireland, the Netherlands and New Zealand that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior CVD event or who were at high risk of their first event. Analyses investigated any differential effect on anthropometric measures and self-reported lifestyle behaviours. Among 3140 patients (75% male, mean age 62 years and 76% with a prior CVD event) there was no difference in lifestyle risk factors in those randomised to polypill-based care compared with usual care over a median of 15 months, either across all participants combined, or in a range of subgroups. Furthermore, narrow confidence intervals (CIs) excluded any major effect for ex le differences between the groups in body mass index was -0.1 (95% CI -0.2 to 0.1) kg/m(2), in weekly duration of moderate intensity physical activity was -2 (-26 to 23) minutes and the proportion of smokers was 16% vs 17% (RR 0.98, 0.84 to 1.15) at the end of trial. This analysis allays concern that polypill-based care may lead to neglect of lifestyle risk factors, at least among high-risk patients. Maximally effective preventive approaches should address lifestyle factors alongside pharmaceutical interventions, as recommended by major international guidelines.
Publisher: Springer Science and Business Media LLC
Date: 21-12-2011
DOI: 10.1007/S00125-011-2404-1
Abstract: There is conflicting evidence regarding appropriate glycaemic targets for patients with type 2 diabetes. Here, we investigate the relationship between HbA(1c) and the risks of vascular complications and death in such patients. Eleven thousand one hundred and forty patients were randomised to intensive or standard glucose control in the Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Glycaemic exposure was assessed as the mean of HbA(1c) measurements during follow-up and prior to the first event. Adjusted risks for each HbA(1c) decile were estimated using Cox models. Possible differences in the association between HbA(1c) and risks at different levels of HbA(1c) were explored using linear spline models. There was a non-linear relationship between mean HbA(1c) during follow-up and the risks of macrovascular events, microvascular events and death. Within the range of HbA(1c) studied (5.5-10.5%), there was evidence of 'thresholds', such that below HbA(1c) levels of 7.0% for macrovascular events and death, and 6.5% for microvascular events, there was no significant change in risks (all p > 0.8). Above these thresholds, the risks increased significantly: every 1% higher HbA(1c) level was associated with a 38% higher risk of a macrovascular event, a 40% higher risk of a microvascular event and a 38% higher risk of death (all p < 0.0001). In patients with type 2 diabetes, HbA(1c) levels were associated with lower risks of macrovascular events and death down to a threshold of 7.0% and microvascular events down to a threshold of 6.5%. There was no evidence of lower risks below these levels but neither was there clear evidence of harm.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 17-09-2013
DOI: 10.1161/CIRCULATIONAHA.113.002717
Abstract: Recent evidence suggests that visit-to-visit variability in systolic blood pressure (SBP) and maximum SBP are predictors of cardiovascular disease. However, it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus. The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) was a factorial randomized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus. The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after randomization. SBP variability (defined as standard deviation) and maximum SBP were determined during the first 24 months after randomization. During a median 2.4 years of follow-up from the 24-month visit, 407 major macrovascular (myocardial infarction, stroke, or cardiovascular death) and 476 microvascular (new or worsening nephropathy or retinopathy) events were observed. The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors (both P .05 for trend). Hazard ratios (95% confidence intervals) for the highest tenth of SBP variability were 1.54 (0.99–2.39) for macrovascular events and 1.84 (1.19–2.84) for microvascular events in comparison with the lowest tenth. For maximum SBP, hazard ratios (95% confidence intervals) for the highest tenth were 3.64 (1.73–7.66) and 2.18 (1.04–4.58), respectively. Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus. URL: www.clinicaltrials.gov . Unique Identifier: NCT00145925.
Publisher: American Thoracic Society
Date: 05-2004
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2009
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-10-2018
DOI: 10.1161/CIRCULATIONAHA.118.035901
Abstract: Canagliflozin is approved for glucose lowering in type 2 diabetes and confers cardiovascular and renal benefits. We sought to assess whether it had benefits in people with chronic kidney disease, including those with an estimated glomerular filtration rate (eGFR) between 30 and 45 mL/min/1.73 m 2 in whom the drug is not currently approved for use. The CANVAS Program randomized 10 142 participants with type 2 diabetes and eGFR mL/min/1.73 m 2 to canagliflozin or placebo. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, with other cardiovascular, renal, and safety outcomes. This secondary analysis describes outcomes in participants with and without chronic kidney disease, defined as eGFR and ≥60 mL/min/1.73 m 2 , and according to baseline kidney function (eGFR , 45 to , 60 to , and ≥90 mL/min/1.73 m 2 ). At baseline, 2039 (20.1%) participants had an eGFR mL/min/1.73 m 2 , 71.6% of whom had a history of cardiovascular disease. The effect of canagliflozin on the primary outcome was similar in people with chronic kidney disease (hazard ratio, 0.70 95% CI, 0.55–0.90) and those with preserved kidney function (hazard ratio, 0.92 95% CI, 0.79–1.07 P heterogeneity = 0.08). Relative effects on most cardiovascular and renal outcomes were similar across eGFR subgroups, with possible heterogeneity suggested only for the outcome of fatal/nonfatal stroke ( P heterogeneity = 0.01), as were results for almost all safety outcomes. The effects of canagliflozin on cardiovascular and renal outcomes were not modified by baseline level of kidney function in people with type 2 diabetes and a history or high risk of cardiovascular disease down to eGFR levels of 30 mL/min/1.73 m 2 . Reassessing current limitations on the use of canagliflozin in chronic kidney disease may allow additional in iduals to benefit from this therapy. URL: www.clinicaltrials.gov . Unique identifiers: NCT01032629, NCT01989754.
Publisher: Cambridge University Press (CUP)
Date: 06-04-2016
DOI: 10.1017/S000711451600088X
Abstract: Population exposure to food and nutrients can be estimated from household food purchases, but store surveys of foods and their composition are more available, less costly and might provide similar information. Our aim was to compare estimates of nutrient exposure from a store survey of packaged food with those from household panel food purchases. A cross-sectional store survey of all packaged foods for sale in two major supermarkets was undertaken in Auckland, New Zealand, between February and May 2012. Longitudinal household food purchase data (November 2011 to October 2012) were obtained from the nationally representative, population-weighted New Zealand Nielsen HomeScan ® panel. Data on 8440 packaged food and non-alcoholic beverage products were collected in the store survey. Food purchase data were available for 1229 households and 16 812 products. Store survey data alone produced higher estimates of exposure to Na and sugar compared with estimates from household panel food purchases. The estimated mean difference in exposure to Na was 94 (95 % CI 72, 115) mg/100 g (20 % relative difference P ·01), to sugar 1·6 (95 % CI 0·8, 2·5) g/100 g (11 % P ·01), to SFA −0·3 (95 % CI −0·8, 0·3) g/100 g (6 % P =0·3) and to energy −18 (−71, 35) kJ/100 g (2 % P =0·51). Compared with household panel food purchases, store survey data provided a reasonable estimate of average population exposure to key nutrients from packaged foods. However, caution should be exercised in using such data to estimate population exposure to Na and sugar and in generalising these findings to other countries, as well as over time.
Publisher: Springer Science and Business Media LLC
Date: 05-08-2010
Abstract: The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst in iduals in whom these treatments are indicated. This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.
Publisher: Elsevier BV
Date: 03-2023
Publisher: BMJ
Date: 17-08-2022
DOI: 10.1136/BMJNPH-2022-000459
Abstract: Front-of-pack labelling (FoPL) aims to promote healthier diets by altering consumer food purchasing behaviour. We quantify the impact of the voluntary Health Star Rating (HSR) FoPL adopted by New Zealand (NZ) in 2014, on (i) the quantity of foods purchased by HSR scores and food groups and (ii) the quantities of different nutrients purchased. We used Nielsen HomeScan household purchasing panel data over 2013–2019, linked to Nutritrack packaged food composition data. Fixed effects analyses were used to estimate the association of HSR with product and nutrient purchasing. We controlled for NZ-wide purchasing trends and potential confounding at the household and product level. In 2019, HSR-labelled products accounted for 24% (2890) of 12 040 products in the dataset and 32% of purchasing volume. Of HSR-labelled products, 1339 (46%) displayed a rating of 4.0–5.0 stars and 556 (19%) displayed a rating of 0.5–2.0 stars. We found little or no association between HSR labelling and the quantities of different foods purchased. Introduction of HSR was, however, associated with lower sodium (−9%, 95% CI −13% to −5%), lower protein (−3%, 95% CI −5% to 0%) and higher fibre (5%, 95% CI 2% to 7%) purchases when purchased products carrying an HSR were compared with the same products prior to introduction of the programme. Robust evidence of HSR labelling changing consumer purchasing behaviour was not observed. The positive effect on nutrient purchasing of HSR-labelled foods likely arises from reformulation of products to achieve a better HSR label.
Publisher: JMIR Publications Inc.
Date: 13-01-2021
DOI: 10.2196/17780
Publisher: Elsevier BV
Date: 03-2020
Publisher: Elsevier BV
Date: 11-2020
Publisher: Springer Science and Business Media LLC
Date: 04-08-2011
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: Elsevier BV
Date: 12-2001
Publisher: SAGE Publications
Date: 2009
DOI: 10.1177/112070000901900108
Abstract: The ability of various pre- or peri-operative variables to determine the risk of developing moderate to severe heterotopic ossification (HO) six to twelve months after surgery was investigated among 407 patients undergoing elective total hip replacement (THR) surgery and allocated to placebo in a randomised controlled trial evaluating NSAIDS-based prophylaxis for HO. Overall, 11 (30%) of the 37 patients undergoing revision surgery developed moderate to severe HO compared with 58 (16%) of the 370 patients undergoing primary THR odds ratio (OR) 2.3, 95% confidence interval (CI) 1.1 to 4.9. Among patients undergoing primary THR, mutually adjusted analysis of collected independent risk factors demonstrated that receiving a transfusion of red cells or having general as well as epidural or spinal anaesthesia present as indicators of increased risk for developing moderate to severe HO. Patients who have undergone revision surgery have a significantly increased risk of clinically relevant ectopic bone, while among patients who have undergone primary THR surgery, those with indicators of excessive surgical bleeding are also at increased risk of clinically relevant HO.
Publisher: Elsevier BV
Date: 05-2021
Publisher: Springer Science and Business Media LLC
Date: 27-07-2016
Publisher: Elsevier BV
Date: 04-1999
Publisher: Massachusetts Medical Society
Date: 16-09-2021
Publisher: S. Karger AG
Date: 2022
DOI: 10.1159/000519920
Abstract: b i Introduction: /i /b KidneyIntelX is a composite risk score, incorporating biomarkers and clinical variables for predicting progression of diabetic kidney disease (DKD). The utility of this score in the context of sodium glucose co-transporter 2 inhibitors and how changes in the risk score associate with future kidney outcomes are unknown. b i Methods: /i /b We measured soluble tumor necrosis factor receptor (TNFR)-1, soluble TNFR-2, and kidney injury molecule 1 on banked s les from CANagliflozin cardioVascular Assessment Study (CANVAS) trial participants with baseline DKD (estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m sup /sup or urine albumin-to-creatinine ratio [UACR] ≥30 mg/g) and generated KidneyIntelX risk scores at baseline and years 1, 3, and 6. We assessed the association of baseline and changes in KidneyIntelX with subsequent DKD progression (composite outcome of an eGFR decline of ≥5 mL/min/year [using the 6-week eGFR as the baseline in the canagliflozin group], ≥40% sustained decline in the eGFR, or kidney failure). b i Results: /i /b We included 1,325 CANVAS participants with concurrent DKD and available baseline plasma s les (mean eGFR 65 mL/min/1.73 m sup /sup and median UACR 56 mg/g). During a mean follow-up of 5.6 years, 131 participants (9.9%) experienced the composite kidney outcome. Using risk cutoffs from prior validation studies, KidneyIntelX stratified patients to low- (42%), intermediate- (44%), and high-risk (15%) strata with cumulative incidence for the outcome of 3%, 11%, and 26% (risk ratio 8.4 95% confidence interval [CI]: 5.0, 14.2) for the high-risk versus low-risk groups. The differences in eGFR slopes for canagliflozin versus placebo were 0.66, 1.52, and 2.16 mL/min/1.73 m sup /sup in low, intermediate, and high KidneyIntelX risk strata, respectively. KidneyIntelX risk scores declined by 5.4% (95% CI: −6.9, −3.9) in the canagliflozin arm at year 1 versus an increase of 6.3% (95% CI: 3.8, 8.7) in the placebo arm ( i /i & #x3c 0.001). Changes in the KidneyIntelX score at year 1 were associated with future risk of the composite outcome (odds ratio per 10 unit decrease 0.80 95% CI: 0.77, 0.83 i /i & #x3c 0.001) after accounting for the treatment arm, without evidence of effect modification by the baseline KidneyIntelX risk stratum or by the treatment arm. b i Conclusions: /i /b KidneyIntelX successfully risk-stratified a large multinational external cohort for progression of DKD, and greater numerical differences in the eGFR slope for canagliflozin versus placebo were observed in those with higher baseline KidneyIntelX scores. Canagliflozin treatment reduced KidneyIntelX risk scores over time and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of the baseline risk score and treatment arm.
Publisher: Elsevier BV
Date: 10-2023
Publisher: Elsevier BV
Date: 2004
Publisher: Elsevier BV
Date: 09-2010
Publisher: Springer Science and Business Media LLC
Date: 24-03-2014
Publisher: American Medical Association (AMA)
Date: 24-02-2010
Publisher: MDPI AG
Date: 02-2019
DOI: 10.3390/NU11020318
Abstract: Recent data on salt intake levels in India show consumption is around 11 g per day, higher than the World Health Organization’s (WHO) recommended intake of 5 g per day. However, high-quality data on sources of salt in diets to inform a salt reduction strategy are mostly absent. A cross-sectional survey of 1283 participants was undertaken in rural, urban, and slum areas in North (n = 526) and South (n = 757) India using an age-, area-, and sex-stratified s ling strategy. Data from two 24-h dietary recall surveys were transcribed into a purpose-built nutrient database. Weighted salt intake was estimated from the average of the two recall surveys, and major contributors to salt intake were identified. Added salt contributed the most to total salt intake, with proportions of 87.7% in South India and 83.5% in North India (p 0.001). The main food sources of salt in the south were from meat, poultry, and eggs (6.3%), followed by dairy and dairy products (2.6%), and fish and seafood (1.6%). In the north, the main sources were dairy and dairy products (6.4%), followed by bread and bakery products (3.3%), and fruits and vegetables (2.1%). Salt intake in India is high, and this research confirms it comes mainly from added salt. Urgent action is needed to implement a program to achieve the WHO salt reduction target of a 30% reduction by 2025. The data here suggest the focus needs to be on changing consumer behavior combined with low sodium, salt substitution.
Publisher: Wiley
Date: 07-2014
DOI: 10.1111/JCH.12364
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2007
Publisher: Wiley
Date: 28-01-2016
Abstract: Communities in rural Andhra Pradesh may be at increasing risk of diabetes. In the present study we analyzed three cross-sectional studies over 9 years to estimate the changing prevalence of dysglycemia (diabetes and prediabetes). The 2005 study s led 4535 in iduals from 20 villages, the 2010 study s led 4024 in iduals from 14 villages, and the 2014 project of 62 254 in iduals sought to include all adults aged 40-85 years from 54 villages. Blood glucose levels were estimated using a hand-held device in 2005 and 2014 and using HbA1c dried blood spots in 2010. In primary analyses restricted to assays based on fasting s les (2005, n = 3243 2014, n = 749), the prevalence estimates for dysglycemia were 53.7% (95% confidence interval [CI] 51.8%-55.7%) in 2005 and 62.0% (95% CI 58.5%-65.4%) in 2014 (P < 0.001). Over the same period, mean body mass index (BMI) increased from 22.2 to 24.3 kg/m The prevalence of dysglycemia was high at every assessment using every measurement method. Dysglycemia in this population is most likely to have risen with the rise in BMI. The decline in prevalence suggested by the secondary analyses was likely due to confounding from the different assessment methods.
Publisher: Oxford University Press (OUP)
Date: 07-04-2021
DOI: 10.1093/CVR/CVAB128
Abstract: Given the benefits of sodium glucose co-transporter 2 inhibition (SGLT2i) in protecting against heart failure in diabetic patients, we sought to explore the potential impact of SGLT2i on the clinical features of patients presenting with myocardial infarction (MI) through a post hoc analysis of CANVAS Programme and CREDENCE trial. In iduals with type 2 diabetes and history or high risk of cardiovascular disease (CANVAS Programme) or type 2 diabetes and chronic kidney disease (CREDENCE) were included. The intervention was canagliflozin 100 or 300 mg (combined in the analysis) or placebo. MI events were adjudicated as ST-elevation myocardial infarction (STEMI), non-STEMI, and type 1 MI or type 2 MI. A total of 421 first MI events in the CANVAS Programme and 178 first MI events in the CREDENCE trial were recorded (83 fatal, 128 STEMI, 431 non-STEMI, and 40 unknown). No benefit of canagliflozin compared with placebo on time to first MI event was observed [hazard ratio (HR) 0.89 95% confidence interval (CI) 0.75, 1.05]. Canagliflozin was associated with lower risk for non-STEMI (HR 0.78 95% CI 0.65, 0.95) but suggested a possible increase in STEMI (HR 1.55 95% CI 1.06, 2.27), with no difference in risk of type 1 or type 2 MI. There was no change in fatal MI (HR 1.22, 95% CI 0.78, 1.93). Canagliflozin was not associated with a reduction in overall MI in the pooled CANVAS Programme and CREDENCE trial population. The possible differential effect on STEMI and Non-STEMI observed in the CANVAS cohort warrants further investigation. ClinicalTrials.gov identifiers: NCT01032629, NCT01989754, and NCT02065791.
Publisher: Springer Science and Business Media LLC
Date: 09-01-2014
Publisher: Elsevier BV
Date: 06-2009
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-11-2016
DOI: 10.1161/CIRCULATIONAHA.116.023233
Abstract: Clinical lipid measurements do not show the full complexity of the altered lipid metabolism associated with diabetes mellitus or cardiovascular disease. Lipidomics enables the assessment of hundreds of lipid species as potential markers for disease risk. Plasma lipid species (310) were measured by a targeted lipidomic analysis with liquid chromatography electrospray ionization–tandem mass spectrometry on a case-cohort (n=3779) subset from the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation). The case-cohort was 61% male with a mean age of 67 years. All participants had type 2 diabetes mellitus with ≥1 additional cardiovascular risk factors, and 35% had a history of macrovascular disease. Weighted Cox regression was used to identify lipid species associated with future cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) and cardiovascular death during a 5-year follow-up period. Multivariable models combining traditional risk factors with lipid species were optimized with the Akaike information criteria. C statistics and NRIs were calculated within a 5-fold cross-validation framework. Sphingolipids, phospholipids (including lyso- and ether- species), cholesteryl esters, and glycerolipids were associated with future cardiovascular events and cardiovascular death. The addition of 7 lipid species to a base model (14 traditional risk factors and medications) to predict cardiovascular events increased the C statistic from 0.680 (95% confidence interval [CI], 0.678–0.682) to 0.700 (95% CI, 0.698–0.702 P .0001) with a corresponding continuous NRI of 0.227 (95% CI, 0.219–0.235). The prediction of cardiovascular death was improved with the incorporation of 4 lipid species into the base model, showing an increase in the C statistic from 0.740 (95% CI, 0.738–0.742) to 0.760 (95% CI, 0.757–0.762 P .0001) and a continuous net reclassification index of 0.328 (95% CI, 0.317–0.339). The results were validated in a subcohort with type 2 diabetes mellitus (n=511) from the LIPID trial (Long-Term Intervention With Pravastatin in Ischemic Disease). The improvement in the prediction of cardiovascular events, above traditional risk factors, demonstrates the potential of plasma lipid species as biomarkers for cardiovascular risk stratification in diabetes mellitus. URL: clinicaltrials.gov . Unique identifier: NCT00145925.
Publisher: Elsevier BV
Date: 11-2019
Publisher: Oxford University Press (OUP)
Date: 05-2010
Publisher: Oxford University Press (OUP)
Date: 22-09-2006
DOI: 10.1093/IJE/DYL168
Abstract: India is undergoing rapid epidemiological transition as a consequence of economic and social change. The pattern of mortality is a key indicator of the consequent health effects but up-to-date, precise, and reliable statistics are few, particularly in rural areas. Deaths occurring in 45 villages (population 180 162) were documented during a 12-month period in 2003-04 by multipurpose primary healthcare workers trained in the use of a verbal autopsy tool. Algorithms were used to define causes of death according to a limited list derived from the international classification of disease version 10. Causes were assigned by two independent physicians with disagreements resolved by a third. A total of 1354 deaths were recorded with verbal autopsies completed for 98%. A specific underlying cause of death was assigned for 82% of all verbal autopsies done. The crude death rate was 7.5/1000 (95% confidence interval, 7.1-7.9). Diseases of the circulatory system were the leading causes of mortality (32%), with similar proportions of deaths attributable to ischaemic heart disease and stroke. Second was injury and external causes of mortality (13%) with one-third of these deaths attributable to deliberate self harm. Third were infectious and parasitic diseases (12%). Tuberculosis and intestinal conditions each caused one-third of deaths within this category. HIV was assigned as the cause for 2% of all deaths. The fourth and fifth leading causes of death were neoplasms (7%) and diseases of the respiratory system (5%). Non-communicable and chronic diseases are the leading causes of death in this part of rural India. The observed pattern of death is unlikely to be unique to these villages and provides new insight into the rapid progression of epidemiological transition in rural India.
Publisher: Elsevier BV
Date: 05-2014
DOI: 10.1016/J.CJCA.2014.02.005
Abstract: High blood pressure is the leading cause of premature mortality worldwide. Reducing salt intake lowers blood pressure and blood pressure-lowering reduces vascular disease. There is a very high likelihood that reducing dietary salt intake will prevent vascular disease and no evidence to suggest it will cause harm. With average population salt consumption levels typically 5-10 times greater than physiological requirements, even moderately effective community-wide salt reduction programs offer the potential for very large health gains. This opportunity has been recognized and adopted by the World Health Organization as a priority action to combat chronic diseases.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2006
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2003
DOI: 10.1161/01.STR.0000091397.81767.40
Abstract: Background and Purpose— We sought to quantify the effects of blood pressure lowering on long-term disability and dependency among patients with cerebrovascular disease. Methods— We performed a randomized, double-blind, placebo-controlled trial. A total of 6105 participants with a history of stroke or transient ischemic attack in the past 5 years were recruited from 172 hospital outpatient clinics in 10 countries. Subjects were randomly assigned to the following groups: active treatment (angiotensin-converting enzyme inhibitor perindopril [4 mg/d] for all patients, with the diuretic indapamide added at the discretion of treating physicians) or matching placebo(s). Measurements were disability (defined as a Barthel Index score ≤99/100) and dependency (a positive response to the following question: “In the last 2 weeks has the patient required regular help with everyday activities?”). Results— The median duration of follow-up was 4 years. At the last available assessment, 19% of the active treatment group and 22% of the placebo group were disabled (adjusted odds ratio, 0.76 95% CI, 0.65 to 0.89 P .001). Twelve percent of the active treatment group and 14% of the placebo group were dependent (adjusted odds ratio, 0.84 95% CI, 0.71 to 0.99 P =0.04). The effects of treatment appeared to be mediated primarily through the prevention of disability and dependency associated with recurrent stroke. Four-year treatment with the study drug regimen would be expected to result in the avoidance of 1 case of long-term disability for every 30 (95% CI, 19 to 79) patients. Conclusions— Among in iduals with cerebrovascular disease, a perindopril-based blood pressure–lowering regimen not only reduced the risk of stroke and major vascular events but also substantially reduced the risks of associated long-term disability and dependency.
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: Public Library of Science (PLoS)
Date: 22-09-2006
Publisher: Frontiers Media SA
Date: 21-09-2022
DOI: 10.3389/PHRS.2022.1605025
Abstract: Objectives: The potential for using routinely collected data for medical research in China remains unclear. We sought to conduct a scoping review to systematically characterise nation-wide routinely collected datasets in China that may be of value for clinical research. Methods: We searched public databases and the websites of government agencies, and non-government organizations. We included nation-wide routinely collected databases related to communicable diseases, non-communicable diseases, injuries, and maternal and child health. Database characteristics, including disease area, data custodianship, data volume, frequency of update and accessibility were extracted and summarised. Results: There were 70 databases identified, of which 46 related to communicable diseases, 20 to non-communicable diseases, 1 to injury and 3 to maternal and child health. The data volume varied from below 1000 to over 100,000 records. Over half (64%) of the databases were accessible for medical research mostly comprising communicable diseases. Conclusion: There are large quantities of routinely collected data in China. Challenges to using such data in medical research remain with various accessibility. The potential of routinely collected data may also be applicable to other low- and middle-income countries.
Publisher: Elsevier BV
Date: 02-2021
Publisher: Wiley
Date: 23-06-2005
DOI: 10.1111/J.1464-5491.2005.01596.X
Abstract: The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level and of intensive glucose lowering, in high-risk in iduals with Type 2 diabetes. The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America. Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11,140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries. With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk in iduals with Type 2 diabetes.
Publisher: Elsevier BV
Date: 06-2021
Publisher: Wiley
Date: 31-08-2009
Publisher: BMJ
Date: 12-2013
Publisher: Elsevier BV
Date: 12-2017
DOI: 10.1016/J.JAND.2017.08.013
Abstract: The Australian Government has introduced a voluntary front-of-package labeling system that includes total sugar in the calculation. Our aim was to determine the effect of substituting added sugars for total sugars when calculating Health Star Ratings (HSR) and identify whether use of added sugars improves the capacity to distinguish between core and discretionary food products. This study included packaged food and beverage products available in Australian supermarkets (n=3,610). The product categories included in the analyses were breakfast cereals (n=513), fruit (n=571), milk (n=309), non-alcoholic beverages (n=1,040), vegetables (n=787), and yogurt (n=390). Added sugar values were estimated for each product using a validated method. HSRs were then estimated for every product according to the established method using total sugar, and then by substituting added sugar for total sugar. The scoring system was not modified when added sugar was used in place of total sugar in the HSR calculation. Products were classified as core or discretionary based on the Australian Dietary Guidelines. To investigate whether use of added sugar in the HSR algorithm improved the distinction between core and discretionary products as defined by the Australian Dietary Guidelines, the proportion of core products that received an HSR of ≥3.5 stars and the proportion of discretionary products that received an HSR of <3.5 stars, for algorithms based upon total vs added sugars were determined. There were 2,263 core and 1,347 discretionary foods 1,684 of 3,610 (47%) products contained added sugar (median 8.4 g/100 g, interquartile range=5.0 to 12.2 g). When the HSR was calculated with added sugar instead of total sugar, an additional 166 (7.3%) core products received an HSR of ≥3.5 stars and 103 (7.6%) discretionary products received a rating of ≥3.5 stars. The odds of correctly identifying a product as core vs discretionary were increased by 61% (odds ratio 1.61, 95% CI 1.26 to 2.06 P<0.001) when the algorithm was based on added compared to total sugars. In the six product categories examined, substitution of added sugars for total sugars better aligned the HSR with the Australian Dietary Guidelines. Future work is required to investigate the impact in other product categories.
Publisher: Springer Science and Business Media LLC
Date: 28-04-2021
DOI: 10.1038/S41586-021-03451-0
Abstract: High-quality and complete reference genome assemblies are fundamental for the application of genomics to biology, disease, and bio ersity conservation. However, such assemblies are available for only a few non-microbial species 1–4 . To address this issue, the international Genome 10K (G10K) consortium 5,6 has worked over a five-year period to evaluate and develop cost-effective methods for assembling highly accurate and nearly complete reference genomes. Here we present lessons learned from generating assemblies for 16 species that represent six major vertebrate lineages. We confirm that long-read sequencing technologies are essential for maximizing genome quality, and that unresolved complex repeats and haplotype heterozygosity are major sources of assembly error when not handled correctly. Our assemblies correct substantial errors, add missing sequence in some of the best historical reference genomes, and reveal biological discoveries. These include the identification of many false gene duplications, increases in gene sizes, chromosome rearrangements that are specific to lineages, a repeated independent chromosome breakpoint in bat genomes, and a canonical GC-rich pattern in protein-coding genes and their regulatory regions. Adopting these lessons, we have embarked on the Vertebrate Genomes Project (VGP), an international effort to generate high-quality, complete reference genomes for all of the roughly 70,000 extant vertebrate species and to help to enable a new era of discovery across the life sciences.
Publisher: Oxford University Press (OUP)
Date: 20-05-2008
Abstract: Large-scale observational studies show that lower blood pressure is associated with lower cardiovascular risk in both men and women although some studies have suggested that different outcomes between the sexes may reflect different responses to blood pressure-lowering treatment. The aims of these overview analyses were to quantify the effects of blood pressure-lowering treatment in each sex and to determine if there are important differences in the proportional benefits of treatment between men and women. Thirty-one randomized trials that included 103,268 men and 87,349 women contributed to these analyses. For each outcome and each comparison summary estimates of effect and 95% confidence intervals were calculated for men and women using a random-effects model. The consistency of the effects of each treatment regimen across the sexes was examined using chi(2) tests of homogeneity. Achieved blood pressure reductions were comparable for men and women in every comparison made. For the primary outcome of total major cardiovascular events there was no evidence that men and women obtained different levels of protection from blood pressure lowering or that regimens based on angiotensin-converting-enzyme inhibitors, calcium antagonists, angiotensin receptor blockers, or diuretics/beta-blockers were more effective in one sex than the other (all P-homogeneity > 0.08). All of the blood pressure-lowering regimens studied here provided broadly similar protection against major cardiovascular events in men and women. Differences in cardiovascular risks between sexes are unlikely to reflect differences in response to blood pressure-lowering treatments.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2016
Publisher: Oxford University Press (OUP)
Date: 10-10-2018
DOI: 10.1093/IJE/DYY206
Abstract: The capacity of spot urine s les for detecting changes in population sodium and potassium excretion is unclear. Changes in urinary sodium and potassium excretion, over a 6-month to 2-year interval, were measured from 24-h urine s les and estimated from spot urine s les using several published methods in 3270 Chinese. Additional estimates were made by multiplying in idual spot sodium and potassium concentrations by a single estimated 24-h urine volume derived from external data. The measured difference in 24-h urinary excretion between intervention and control groups was -0.35 g (95% CI: -0.68 to -0.02 P = 0.039) for sodium and 0.66 g (95% CI: 0.52 to 0.80 P 0.10). The estimates were -0.65 g for sodium and 1.11 g for potassium using in idual spot urine concentrations and an externally derived standard urine volume (both P < 0.01). The published equations were unable to detect the differences in sodium excretion measured by 24-h urine s les. A method based upon spot urine electrolyte concentrations and a standard urine volume may offer an alternative approach to measuring differences in sodium and potassium excretion between population groups without requiring 24-h urine, but will need further investigation.
Publisher: Elsevier BV
Date: 11-2013
DOI: 10.1016/J.YPMED.2013.07.024
Abstract: In 2006 the UK Food Standards Agency (FSA) introduced voluntary sodium reduction targets for more than 80 categories of processed food. Our aim was to determine the impact of these targets on the sodium content of processed foods in the UK between 2006 and 2011. Household consumer panel data (n>18,000 households) were used to calculate crude and sales-weighted mean sodium content for 47,337 products in 2006 and 49,714 products in 2011. Two s le t-tests were used to compare means. A secondary analysis was undertaken to explore reformulation efforts and included only products available for sale in both 2006 and 2011. Between 2006 and 2011 there was an overall mean reduction in crude sodium content of UK foods of -26 mg/100g (p ≤ 0.001), equivalent to a 7% fall (356 mg/100g to 330 mg/100g). The corresponding sales-weighted reduction was -21 mg/100g (-6%). For products available for sale in both years the corresponding reduction was -23 mg/100g (p<0.001) or -7%. The UK FSA voluntary targets delivered a moderate reduction in the mean sodium content of UK processed foods between 2006 and 2011. Whilst encouraging, regular monitoring and review of the UK sodium reduction strategy will be essential to ensure continued progress.
Publisher: Cambridge University Press (CUP)
Date: 17-03-2016
DOI: 10.1017/S0007114516000799
Abstract: Despite the potential of declared serving size to encourage appropriate portion size consumption, most countries including Australia have not developed clear reference guidelines for serving size. The present study evaluated variability in manufacturer-declared serving size of discretionary food and beverage products in Australia, and how declared serving size compared with the 2013 Australian Dietary Guideline (ADG) standard serve (600 kJ). Serving sizes were obtained from the Nutrition Information Panel for 4466 packaged, discretionary products in 2013 at four large supermarkets in Sydney, Australia, and categorised into fifteen categories in line with the 2013 ADG. For unique products that were sold in multiple package sizes, the percentage difference between the minimum and the maximum serving size across different package sizes was calculated. A high variation in serving size was found within the majority of food and beverage categories – for ex le, among 347 non-alcoholic beverages (e.g. soft drinks), the median for serving size was 250 (interquartile range (IQR) 250, 355) ml (range 100–750 ml). Declared serving size for unique products that are available in multiple package sizes also showed high variation, particularly for chocolate-based confectionery, with median percentage difference between minimum and maximum serving size of 183 (IQR 150) %. Categories with a high proportion of products that exceeded the 600 kJ ADG standard serve included cakes and muffins, pastries and desserts (≥74 % for each). High variability in declared serving size may confound interpretation and understanding of consumers interested in standardising and controlling their portion selection. Future research is needed to assess if and how standardising declared serving size might affect consumer behaviour.
Publisher: Massachusetts Medical Society
Date: 20-02-2020
Publisher: Wiley
Date: 28-03-2013
Publisher: Elsevier BV
Date: 09-2020
Publisher: MDPI AG
Date: 21-08-2015
DOI: 10.3390/NU7085321
Publisher: John Wiley & Sons, Ltd
Date: 19-07-2004
Publisher: Elsevier BV
Date: 06-2009
Publisher: BMJ
Date: 09-01-2015
Publisher: Massachusetts Medical Society
Date: 09-10-2014
Publisher: Elsevier
Date: 2013
Publisher: Elsevier BV
Date: 11-2014
Publisher: American Diabetes Association
Date: 14-06-2018
DOI: 10.2337/DC18-0158
Abstract: In observational cohorts, adiponectin is inversely associated and free fatty acids (FFAs) are directly associated with incident coronary heart disease (CHD). Adiponectin tends to be reduced and FFAs elevated in type 2 diabetes. We investigated relationships of adiponectin and FFA and major adverse cardiovascular events (MACEs) and death in patients with acute coronary syndrome (ACS) and type 2 diabetes using data from the AleCardio (Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus) trial, which compared the PPAR-α/γ agonist aleglitazar with placebo. Using Cox regression adjusted for demographic, laboratory, and treatment variables, we determined associations of baseline adiponectin and FFAs, or the change in adiponectin and FFAs from baseline, with MACEs (cardiovascular death, myocardial infarction, or stroke) and death. A twofold higher baseline adiponectin (n = 6,998) was directly associated with risk of MACEs (hazard ratio [HR] 1.17 [95% CI 1.08–1.27]) and death (HR 1.53 [95% CI 1.35–1.73]). A doubling of adiponectin from baseline to month 3 (n = 6,325) was also associated with risk of death (HR 1.20 [95% CI 1.03–1.41]). Baseline FFAs (n = 7,038), but not change in FFAs from baseline (n = 6,365), were directly associated with greater risk of MACEs and death. There were no interactions with study treatment. In contrast to prior observational data for incident CHD, adiponectin is prospectively associated with MACEs and death in patients with type 2 diabetes and ACS, and an increase in adiponectin from baseline is directly related to death. These findings raise the possibility that adiponectin has different effects in patients with type 2 diabetes and ACS than in populations without prevalent cardiovascular disease. Consistent with prior data, FFAs are directly associated with adverse outcomes.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2006
Publisher: American Medical Association (AMA)
Date: 14-04-2020
Publisher: Springer Science and Business Media LLC
Date: 17-06-2015
Publisher: Elsevier BV
Date: 11-2016
Publisher: Oxford University Press (OUP)
Date: 03-2003
DOI: 10.1016/S0195-668X(02)00804-7
Abstract: To determine the effects of a perindopril-based blood pressure lowering regimen on major cardiac events among hypertensive and non-hypertensive patients with a history of cerebrovascular disease. A total of 6105 in iduals with a history of stroke or transient ischaemic attack were randomly assigned active treatment (n=3051) or placebo (n=3054). Active treatment comprised the angiotensin-converting-enzyme inhibitor perindopril (4 mg daily), with the addition of the diuretic indapamide at the discretion of treating physicians. Over a mean of 3.9 years of follow-up, active treatment reduced blood pressure by 9/4 mm Hg compared with placebo and reduced the primary outcome, stroke, by 28%. Major coronary events occurred in 269 participants (active 3.8%, placebo 5.0%) and heart failure was diagnosed in 264 participants (active 3.7%, placebo 4.9%). Active treatment reduced the risk of major coronary events by 26% (95% CI: 6-42% p=0.02) and the risk of congestive heart failure by 26% (5-42% p=0.02). For each of these outcomes, there was no clear evidence of differences between the treatment effects in participants classified as hypertensive or non-hypertensive, and those with or without a history of coronary heart disease. Among in iduals with cerebrovascular disease, blood pressure lowering with a regimen involving perindopril and indapamide not only reduced the risk of stroke, but also substantially reduced the risks of cardiac outcomes.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2007
Publisher: Elsevier BV
Date: 2020
Publisher: Elsevier BV
Date: 07-2017
Publisher: American Medical Association (AMA)
Date: 28-11-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 21-07-2020
Abstract: Traditionally, clinical trials studying effects of new therapies on renal outcome use the doubling of serum creatinine (equivalent to a 57% eGFR reduction) as an end point, requiring large s le sizes. Use of lesser eGFR reductions has been proposed, but few studies have evaluated their reliability. In this post hoc study of two multicenter, randomized trials, a greater number of observed events resulted from use of 50%, 40%, and 30% eGFR reductions compared with a 57% eGFR reduction. Observed effect sizes for canagliflozin versus placebo were attenuated when lesser eGFR reductions were used, likely because of canagliflozin’s acute effect on eGFR. However, if analyses control for this acute effect, lesser eGFR decline thresholds may be preferred to identify renoprotective effects of potential therapies because much smaller s le sizes can be used. Traditionally, clinical trials evaluating effects of a new therapy with creatinine-based renal end points use doubling of serum creatinine (equivalent to a 57% eGFR reduction), requiring large s le sizes. To assess whether eGFR declines % could detect canagliflozin’s effects on renal outcomes, we conducted a post hoc study comparing effects of canagliflozin versus placebo on composite renal outcomes using sustained 57%, 50%, 40%, or 30% eGFR reductions in conjunction with ESKD and renal death. Because canagliflozin causes an acute reversible hemodynamic decline in eGFR, we made estimates using all eGFR values as well as estimates that excluded early measures of eGFR influenced by the acute hemodynamic effect. Among the 10,142 participants, 93 (0.9%), 161 (1.6%), 352 (3.5%), and 800 (7.9%) participants recorded renal outcomes on the basis of 57%, 50%, 40%, or 30% eGFR reduction, respectively, during a mean follow-up of 188 weeks. Compared with a 57% eGFR reduction (risk ratio [RR], 0.51 95% confidence interval [95% CI], 0.34 to 0.77), the effect sizes were progressively attenuated when using 50% (RR, 0.61 95% CI, 0.45 to 0.83), 40% (RR, 0.70 95% CI, 0.57 to 0.86), or 30% (RR, 0.81 95% CI, 0.71 to 0.93) eGFR reductions. In analyses that controlled for the acute hemodynamic fall in eGFR, effect sizes were comparable, regardless of whether a 57%, 50%, 40%, or 30% eGFR reduction was used. Estimated s le sizes for studies on the basis of lesser eGFR reductions were much reduced by controlling for this early hemodynamic effect. Declines in eGFR % may provide robust estimates of canagliflozin’s effects on renal outcomes if the analysis controls for the drug’s acute hemodynamic effect. CANagliflozin cardioVascular Assessment Study (CANVAS), NCT01032629 and CANVAS-R, NCT01989754.
Publisher: SAGE Publications
Date: 24-09-2016
Abstract: Traditionally, verbal autopsies (VA) are collected on paper-based questionnaires and reviewed by physicians for cause of death assignment, it is resource intensive and time consuming. The Population Health Metrics Research Consortium VA questionnaires was made available on an Android-based application and cause of death was derived using the Tariff method. Over one year, all adult deaths occurring in 48 villages in 4 counties were identified and a VA interview was conducted using the smartphone VA application. A total of 507 adult deaths were recorded and VA interviews were conducted. Cardiovascular disease was the leading cause of death (35.3%) followed by injury (14.6%) and neoplasms (13.5%). The total cost of the pilot study was USD28 835 (USD0.42 per capita). The interviewers found use of smartphones to conduct interviews to be easier. The study showed that using a smartphone application for VA interviews was feasible for implementation in rural China.
Publisher: BMJ
Date: 20-01-2022
DOI: 10.1136/HEARTJNL-2021-320171
Abstract: Evidence from randomised trials of pharmacological treatments on long-term blood pressure (BP) reduction is limited. We investigated the antihypertensive drug effects on BP over time and across different participant characteristics. We conducted an in idual patient-level data meta-analysis of 52 large-scale randomised clinical trials in the Blood Pressure Lowering Treatment Trialists’ Collaboration using mixed models to examine treatment effects on BP over 4 years of mean follow-up. There were 363 684 participants (42% women), with baseline mean age=65 years and mean systolic/diastolic BP=152/87 mm Hg, and among whom 19% were current smokers, 49% had cardiovascular disease, 28% had diabetes and 69% were taking antihypertensive treatment at baseline. Drugs were effective in lowering BP showing maximal effect after 12 months and gradually attenuating towards later years. Based on measures taken ≥12 months postrandomisation, mean systolic/diastolic BP difference (95% CI) between more and less intense BP-lowering treatment was −11.1 (−11.3 to −10.8)/−5.6 (−5.7 to −5.4) mm Hg between active treatment and placebo was −5.1 (−5.3 to −5.0)/−2.3 (−2.4 to −2.2) mm Hg and between active and control arms for drug comparison trials was −1.4 (−1.5 to −1.3)/−0.6 (−0.7 to −0.6) mm Hg. BP reductions were observed across different baseline BP values and ages, and by sex, history of cardiovascular disease and diabetes and prior antihypertensive treatment use. These findings suggest that BP-lowering pharmacotherapy is effective in lowering BP, up to 4 years on average, in people with different characteristics. Appropriate treatment strategies are needed to sustain substantive long-term BP reductions.
Publisher: Wiley
Date: 14-05-2019
DOI: 10.1111/JCH.13551
Publisher: SAGE Publications
Date: 03-2012
Abstract: Glucose in the glomerular ultrafiltrate is actively reabsorbed by sodium glucose transporters (SGLT) in the proximal tubule. The SGLT2 protein is a high capacity molecule responsible for the majority of glucose reuptake with pharmacological inhibition, resulting in the loss of about 80g of glucose in the urine each day. About a dozen inhibitors of SGLT2 have entered clinical development, and the first has recently been submitted for registration with the United States Food and Drug Administration. The rationale for the clinical evaluation of these agents is their beneficial effects on glycaemia, blood pressure and body weight. No adequately powered trial has yet determined the effects of an SGLT2 inhibitor on either macrovascular or microvascular outcomes, although a number of large-scale trials are now ongoing. Evidence that will define the overall balance of benefits and risks of this new drug class is anticipated within the next 5 years.
Publisher: AMPCo
Date: 09-2011
DOI: 10.5694/MJA11.10673
Abstract: To define the effectiveness of recent efforts by the Australian Division of World Action on Salt and Health, and the Heart Foundation in New Zealand to reduce sodium levels in breads in Australia and New Zealand. Data on the sodium contents of packaged sliced bread products sold in Australian and New Zealand supermarkets were collected from the product labels of 157 breads in 2007 and 167 breads in 2010, and were compared overall, by bread type, by manufacturer, and between nations. Mean sodium values in bread and proportions of breads meeting the targets of 400 mg/100 g in Australia and 450 mg/100 g in New Zealand. Overall mean sodium content in bread in Australia was 434 mg/100 g in 2007 and 435 mg/100 g in 2010 corresponding values for New Zealand were 469 mg/100 g and 439 mg/100 g. The proportion of Australian breads meeting the national target increased from 29% in 2007 to 50% in 2010 the proportion of New Zealand breads meeting the national target increased from 49% in 2007 to 90% in 2010. There were clear differences between the results achieved by different companies. Voluntary efforts by non-governmental organisations have had some impact on sodium levels in bread, particularly in New Zealand. However, substantial room for further improvement remains. If additional reductions are not achieved under the current voluntary arrangements, legislated approaches may be required.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-2002
DOI: 10.1161/01.HYP.0000040263.94619.D5
Abstract: The objective of this study was to estimate the prevalence and distribution of hypertension and to determine the status of hypertension awareness, treatment, and control in the general adult population in China. The International Collaborative Study of Cardiovascular Disease in ASIA (InterASIA), conducted in 2000–2001, used a multistage cluster s ling method to select a nationally representative s le. A total of 15 540 adults, age 35 to 74 years, were examined. Three blood pressure measurements were obtained by trained observers by use of a standardized mercury sphygmomanometer after a 5-minute sitting rest. Information on history of hypertension and use of antihypertensive medications was obtained by use of a standard questionnaire. Hypertension was defined as a mean systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥90 mm Hg, and/or use of antihypertensive medications. Overall, 27.2% of the Chinese adult population age 35 to 74 years, representing 129 824 000 persons, had hypertension. The age-specific prevalence of hypertension was 17.4%, 28.2%, 40.7%, and 47.3% in men and 10.7%, 26.8%, 38.9%, and 50.2% in women age 35 to 44 years, 45 to 54 years, 55 to 64 years, and 65 to 74 years, respectively. Among hypertensive patients, only 44.7% were aware of their high blood pressure, 28.2% were taking antihypertensive medication, and 8.1% achieved blood pressure control ( /90 mm Hg). Our results indicate that hypertension is highly prevalent in China. The percentages of those with hypertension who are aware, treated, and controlled are unacceptably low. These results underscore the urgent need to develop national strategies to improve prevention, detection, and treatment of hypertension in China.
Publisher: Elsevier BV
Date: 09-1999
Publisher: Elsevier BV
Date: 10-2017
DOI: 10.1016/J.APPET.2017.06.005
Abstract: In June 2014, the Australian government agreed to the voluntary implementation of an interpretive 'Health Star Rating' (HSR) front-of-pack labelling system for packaged foods. The aim of the system is to make it easier for consumers to compare the healthiness of products based on number of stars. With many Australians consuming fast food there is a strong rationale for extending the HSR system to include fast food items. To examine the performance of the HSR system when applied to fast foods. Nutrient content data for fast food menu items were collected from the websites of 13 large Australian fast-food chains. The HSR was calculated for each menu item. Statistics describing HSR values for fast foods were calculated and compared to results for comparable packaged foods. Data for 1529 fast food products were compared to data for 3810 packaged food products across 16 of 17 fast food product categories. The mean HSR for the fast foods was 2.5 and ranged from 0.5 to 5.0 and corresponding values for the comparator packaged foods were 2.6 and 0.5 to 5.0. Visual inspection of the data showed broadly comparable distributions of HSR values across the fast food and the packaged food categories, although statistically significant differences were apparent for seven categories (all p < 0.04). In some cases these differences reflected the large s le size and the power to detect small variations across fast foods and packaged food, and in others it appeared to reflect primarily differences in the mix of product types within a category. These data support the idea that the HSR system could be extended to Australian fast foods. There are likely to be significant benefits to the community from the use of a single standardised signposting system for healthiness across all fresh, packaged and restaurant foods.
Publisher: MDPI AG
Date: 30-07-2018
DOI: 10.3390/NU10080997
Abstract: In June 2014, Australia and New Zealand adopted a voluntary front-of-pack nutrition labelling scheme in the form of the Health Star Rating (HSR) system. Our aim was to assess its uptake in Australia while a formal five-year review of the system is underway. Numbers and proportions of products eligible to carry a HSR were recorded each year between 2014 and 2017 as part of an annual survey of four large Australian retail outlets. Mean HSR values were determined for products that were and were not labelled with a HSR logo, and summary data presented overall, by HSR score, by major food category, and for leading manufacturers. Results show that uptake is increasing: HSR appeared on 4348/15,767 (28%) of eligible products in 2017 and has now appeared on 7922 products since implementation. Of those products displaying a HSR logo, more than three-quarters (76.4%) displayed a HSR of ≥3.0. Products displaying a HSR logo had a higher mean HSR (3.4), compared to products not displaying a HSR logo (2.7). Uptake was highest on convenience foods (44%), cereals (36.7%), and fruit and vegetable products (35.9%). More than 100 manufacturers were using the system, but retailers Coles, Woolworths and Aldi were together responsible for 54% of uptake. For all except Coles, Woolworths and C bell Arnott’s, the mean HSR of products displaying a logo on pack was higher than products made by that manufacturer not showing a HSR logo. We conclude that to ensure the consistent and widespread uptake required for consumers to make informed food purchases, HSR should be made mandatory at the conclusion of the five-year review.
Publisher: American Diabetes Association
Date: 22-03-2016
DOI: 10.2337/DC15-2322
Abstract: The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial reported that intensive glucose control prevents end-stage kidney disease (ESKD) in patients with type 2 diabetes, but uncertainty about the balance between risks and benefits exists. Here, we examine the long-term effects of intensive glucose control on risk of ESKD and other outcomes. Survivors, previously randomized to intensive or standard glucose control, were invited to participate in post-trial follow-up. ESKD, defined as the need for dialysis or kidney transplantation, or death due to kidney disease, was documented overall and by baseline CKD stage, along with hypoglycemic episodes, major cardiovascular events, and death from other causes. A total of 8,494 ADVANCE participants were followed for a median of 5.4 additional years. In-trial HbA1c differences disappeared by the first post-trial visit. The in-trial reductions in the risk of ESKD (7 vs. 20 events, hazard ratio [HR] 0.35, P = 0.02) persisted after 9.9 years of overall follow-up (29 vs. 53 events, HR 0.54, P & 0.01). These effects were greater in earlier-stage CKD (P = 0.04) and at lower baseline systolic blood pressure levels (P = 0.01). The effects of glucose lowering on the risks of death, cardiovascular death, or major cardiovascular events did not differ by levels of kidney function (P & 0.26). Intensive glucose control was associated with a long-term reduction in ESKD, without evidence of any increased risk of cardiovascular events or death. These benefits were greater with preserved kidney function and with well-controlled blood pressure.
Publisher: Wiley
Date: 17-02-2021
DOI: 10.1002/EHF2.13236
Abstract: The CANVAS Program identified the effect of canagliflozin on major adverse cardiovascular events (MACE) differed according to whether participants were using diuretics at study commencement. We sought to further evaluate this finding related to baseline differences, treatment effects, safety, and risk factor changes. The CANVAS Program enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomized to canagliflozin or placebo and followed for a mean of 188 weeks. The primary outcome was major cardiovascular events, a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included multiple cardiovascular, renal, and safety events. In this post hoc subgroup analysis, participants were categorized according to baseline use of any diuretic. The effect on outcomes was compared using Cox proportional hazards models, while risk factor changes were compared using mixed‐effect models. At baseline, 4490 (44.3%) participants were using a diuretic. Compared with those not using a diuretic, participants using a diuretic were more likely to be older (mean age ± standard deviation, 64.3 ± 8.0 vs. 62.5 ± 8.3), be female (38.9% vs. 33.4%), and have heart failure (19.6% vs. 10.3%) (all P difference 0.0001). The effect of canagliflozin on major cardiovascular events was greater for those using diuretic at baseline than for those who were not [adjusted hazard ratio 0.65 (95% confidence interval 0.54–0.78) vs. adjusted hazard ratio 1.13 (95% confidence interval 0.93–1.36), P heterogeneity 0.0001]. Changes in most risk factors, including blood pressure, body weight, and urine albumin‐to‐creatinine ratio, were similar between groups (all P difference 0.11), although the effect of canagliflozin on haemoglobin A1c reduction was slightly weaker in participants using compared with not using diuretics at baseline (−0.52% vs. −0.64%, P heterogeneity = 0.0007). Overall serious adverse events and key safety outcomes, including adverse renal events, were also similar (all P heterogeneity 0.07). Participants on baseline diuretics derived a greater benefit for major cardiovascular events from canagliflozin, which was not fully explained by differences in participant characteristics nor risk factor changes.
Publisher: Elsevier BV
Date: 05-2020
Publisher: American Medical Association (AMA)
Date: 11-07-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2019
Publisher: Elsevier BV
Date: 12-2019
Publisher: Oxford University Press (OUP)
Date: 02-2016
DOI: 10.1093/IJE/DYW005
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2003
DOI: 10.1161/01.HYP.0000088322.85804.96
Abstract: The insertion/deletion ( I/D ) polymorphism of the angiotensin-converting enzyme (ACE) gene might have consequences for the risks of vascular diseases. We examined the ACE genotype and the effects of a perindopril-based blood pressure-lowering regimen on macrovascular events, dementia, and cognitive decline among hypertensive and nonhypertensive patients with a history of cerebrovascular disease. ACE I/D genotypes were measured in 5688 of 6105 in iduals with previous stroke or transient ischemic attack who participated in the PROGRESS trial. The DD genotype was significantly ( P .0001) less frequent in Asian subjects (Chinese and Japanese, 14.7%) than in non-Asian subjects (32.0%). Controlling for racial background, there were no associations between ACE genotypes and cerebrovascular disease history or cardiovascular risk factors, including baseline blood pressure. The ACE genotype was not associated with the long-term risks of stroke, cardiac events, mortality, dementia, or cognitive decline neither did the ACE genotype predict the blood pressure reduction associated with the use of the ACE inhibitor perindopril. Similarly, there was no evidence that the ACE genotype modified the relative benefits of ACE inhibitor-based therapy over placebo. This study provides no evidence that in patients with cerebrovascular disease, knowledge of ACE genotype is useful for predicting either the risk of disease or the benefits of perindopril-based blood pressure-lowering treatment.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2014
Publisher: JMIR Publications Inc.
Date: 14-07-2021
DOI: 10.2196/27423
Abstract: Regular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. The aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. Low-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords “salt substitute,” “low-sodium salt,” “potassium salt,” “mineral salt,” and “sodium reduced salt” in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. A total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. Low-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. RR2-10.1111/jch.14054
Publisher: Elsevier BV
Date: 08-2010
DOI: 10.1016/J.DIABRES.2010.05.012
Abstract: The aim of these analyses was to examine the efficacy of the intensive gliclazide MR-based glucose lowering regimen used in the ADVANCE trial in lowering the level of glycated haemoglobin (HbA1c). All 11,140 randomised patients were included in analyses of treatment efficacy. Treatment efficacy was also examined in subgroups defined by baseline characteristics and treatments. At the end of 5 years follow-up, the mean HbA1c was reduced from 7.5% at baseline to 6.5% in those on intensive glucose control and to 7.3% in those on standard glucose control. With intensive glucose lowering greater proportions achieved HbA1c levels of < or =7.0%, < or =6.5% and < or =6.0%. With intensive glucose lowering substantial reductions in HbA1c were observed across subgroups defined by baseline age, sex, duration of diabetes, BMI, HbA1c or treatment regimen (p<0.0001). The main independent predictors of reduction in HbA1c during follow-up were baseline HbA1c, duration of diabetes and BMI. There was no weight gain in the intensive glucose control group and severe hypoglycaemia was uncommon, though more frequent than in the standard control group. Intensive glucose control with a gliclazide MR-based regimen was well tolerated and consistently effective in lowering HbA1c across a broad range of patient with type 2 diabetes.
Publisher: Elsevier BV
Date: 03-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2018
Publisher: BMJ
Date: 2016
Publisher: Elsevier BV
Date: 09-2022
Publisher: Wiley
Date: 13-10-2020
DOI: 10.1111/DOM.14197
Abstract: Sodium‐glucose co‐transporter‐2 (SGLT2) inhibitors are effective for the treatment of macrovascular complications and nephropathy in type 2 diabetes, but effects on microvascular eye outcomes are unclear. We conducted a systematic review and meta‐analysis of randomized placebo‐controlled trials to evaluate the effect of SGLT2 inhibition on total ocular events and retinopathy in patients with type 2 diabetes. We searched MEDLINE and Embase for the period from database inception date to October 11, 2019. Two reviewers working independently extracted relevant data. Random‐effects models with inverse variance weighting were selected to estimate summary risk ratios (RRs) and 95% confidence intervals (CIs). We included nine studies, involving 39 982 patients with a mean follow‐up of 2.8 years. There were 1414 total ocular events, of which 624 were retinopathy events. SGLT2 inhibition was not associated with a change in the risk of total ocular events (RR 0.97, 95% CI 0.85, 1.11) or retinopathy (RR 0.98, 95% CI 0.84, 1.16), with consistent effects across studies ( P for heterogeneity = 0.35 and 0.45, respectively). The effects of SGLT2 inhibition on eye disease in in iduals with type 2 diabetes are probably null, although the available data cannot exclude small to moderate benefits or harms.
Publisher: American Diabetes Association
Date: 11-12-2013
DOI: 10.2337/DC13-1165
Abstract: Current methods of risk stratification in patients with type 2 diabetes are suboptimal. The current study assesses the ability of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (hs-cTnT) to improve the prediction of cardiovascular events and death in patients with type 2 diabetes. A nested case-cohort study was performed in 3,862 patients who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Seven hundred nine (18%) patients experienced a major cardiovascular event (composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and 706 (18%) died during a median of 5 years of follow-up. In Cox regression models, adjusting for all established risk predictors, the hazard ratio for cardiovascular events for NT-proBNP was 1.95 per 1 SD increase (95% CI 1.72, 2.20) and the hazard ratio for hs-cTnT was 1.50 per 1 SD increase (95% CI 1.36, 1.65). The hazard ratios for death were 1.97 (95% CI 1.73, 2.24) and 1.52 (95% CI 1.37, 1.67), respectively. The addition of either marker improved 5-year risk classification for cardiovascular events (net reclassification index in continuous model, 39% for NT-proBNP and 46% for hs-cTnT). Likewise, both markers greatly improved the accuracy with which the 5-year risk of death was predicted. The combination of both markers provided optimal risk discrimination. NT-proBNP and hs-cTnT appear to greatly improve the accuracy with which the risk of cardiovascular events or death can be estimated in patients with type 2 diabetes.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2009
DOI: 10.1161/HYPERTENSIONAHA.109.133041
Abstract: The relative importance of various blood pressure indices on cardiovascular risk in people with type 2 diabetes mellitus has not been established. This study compares the strengths of the associations between different baseline blood pressure variables (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse pressure [PP], and mean arterial pressure) and the 4.3-year risk of major cardiovascular events in the Action in Diabetes and Vascular Disease: Preterax and Diamicron-Modified Release Controlled Evaluation Study. Mean (SD) age for the 11 140 participants was 65.8 years (6.4 years). During follow-up, 1000 major cardiovascular events, 559 major coronary events, and 468 cardiovascular deaths were recorded. After adjustment for age, sex, and treatment allocation, the hazard ratios (95% CIs) associated with 1 increment in SD for the risk of major cardiovascular events were 1.17 (1.10 to 1.24) for SBP 1.20 (1.13 to 1.28) for PP 1.12 (1.05 to 1.19) for mean arterial pressure and 1.04 (0.98 to 1.11) for DBP. The areas under the receiver operating characteristic curve were slightly higher for SBP and PP compared with mean arterial pressure and DBP for major cardiovascular and coronary events. Using achieved instead of baseline blood pressure values marginally improved the effect estimates for SBP, DBP, and mean arterial pressure, with no significant differences in the areas under the receiver operating characteristic curve between models with SBP and those with PP. In conclusion, SBP and PP are the 2 best and DBP is the least effective determinant of the risk of major cardiovascular outcomes in the relatively old patients with type 2 diabetes mellitus participating in the Action in Diabetes and Vascular Disease: Preterax and Diamicron-Modified Release Controlled Evaluation Study. However, SBP may be the simplest and most useful predictor across a wider range of age groups and populations.
Publisher: Oxford University Press (OUP)
Date: 09-2021
Abstract: Front-of-pack nutrition labelling (FoPL) of packaged foods can promote healthier diets. Australia & New Zealand (NZ) adopted the voluntary Health Star Rating (HSR) scheme in 2014. We studied the impact of voluntary adoption of HSR on food reformulation overall, and for more- versus less-healthy foods. Annual nutrition information panel data was collected for non-seasonal packaged foods sold in major supermarkets in Auckland from 2013-19, and Sydney from 2014-18. We used difference-in-differences to estimate reformulation associated with HSR adoption. Healthier products adopted HSR more than unhealthy products: 35% of products that achieved four or more stars displayed the label compared to 15% of products that achieved two stars or less. Products that adopted HSR were 6.5% & 10.7% more likely to increase their rating by ≥ 0.5 stars in Australia and NZ, respectively. Labelled products showed a -4.2% [95% CI -6.5% to -1.9%] relative decline in sodium content in NZ, but there was no sodium change in Australia. There was a -2.3% [-3.7% to -1.0 %] change in sugar content in NZ and a -1.1% [-2.2% to 0.0%] difference in Australia. Initially unhealthy products showed larger reformulation when adopting HSR than healthier products. Overall, introduction of HSR had a small effect on product reformulation. The voluntary nature of the HSR program lowers effectiveness because labels were mostly placed on already healthy products. These already healthy products had limited scope for reformulation. HSR adoption by unhealthy products should be incentivized, or mandated, by governments to maximise reformulation
Publisher: Elsevier BV
Date: 09-2002
DOI: 10.1016/S0168-8227(02)00083-9
Abstract: The association between alcohol consumption and the risk of diabetes in Japanese with a low-body mass index (BMI) ( or =25.0 kg/m(2)) was investigated among a cohort of 5,636 employees of a Japanese insurance company. Participants were free of diabetes at baseline and were followed up for a mean of 5.7 years with annual assessments of fasting plasma glucose (FPG). The outcome was a clinical diagnosis of diabetes on the basis of a questionnaire administered at each follow-up assessment or a follow-up FPG level of 7.8 mmol/l or more. Relative risks and 95% confidence intervals (95% CIs) were estimated by fitting pooled logistic regression models, which included age, gender, BMI, baseline FPG level, current tobacco use and current alcohol consumption. A total of 264 outcome events were recorded. The relative risk of diabetes associated with current alcohol consumption was 3.19 (95% CI 1.09-9.37) among low-BMI in iduals, 0.41 (0.23-0.73) among middle-BMI in iduals and 0.74 (0.44-1.25) among high-BMI in iduals. In this study, current alcohol consumption was associated with an increased risk of diabetes among low-BMI in iduals and a decreased risk of diabetes among middle-BMI in iduals. A tendency for an association of alcohol consumption with a decreased risk of diabetes among high-BMI in iduals was noted, although without statistical significance.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2009
DOI: 10.1161/STROKEAHA.109.563932
Abstract: Background and Purpose— Patients with cerebral amyloid angiopathy (CAA) are at high risk for intracerebral hemorrhage (ICH), but no effective prevention strategies have been established. The objective is to determine whether lowering of blood pressure (BP) provides protection for this high-risk patient group. Methods— This study is a subsidiary analysis of the PROGRESS trial—a randomized, placebo-controlled trial that established the beneficial effects of BP lowering in patients with cerebrovascular disease 6105 patients were randomly assigned to either active treatment (perindopril for all participants plus indapamide for those with neither an indication for nor a contraindication to a diuretic) or matching placebo. Outcomes were probable CAA-related ICH as defined by the Boston criteria, probable hypertension-related ICH, and unclassified ICH. Results— Over a mean follow-up of 3.9 years, 16 probable CAA-related ICH, 51 probable hypertension-related ICH, and 44 unclassified ICH occurred. Active treatment reduced the risk of CAA-related ICH by 77% (95% CI, 19%–93%), that of hypertension-related ICH by 46% (95% CI, 4%–69%), and that of unclassified ICH by 43% (95% CI, −5%–69%). There was no evidence of differences in the magnitude of the effects of treatment among different types of ICH ( P homogeneity=0.4). Conclusions— BP-lowering treatment is likely to provide protection against all types of ICH.
Publisher: MDPI AG
Date: 22-04-2020
DOI: 10.3390/NU12041162
Abstract: Processed food is associated with unhealthy qualities such as higher content of harmful fats, sugars and salt. The aim of our study was to compare the nutritional qualities of supermarket’s own brands and regular brands of bread sold in Sweden. Additionally, we compared the nutritional qualities of gluten-free and gluten-containing bread. We collected information from the labels of 332 bread products available in the largest grocery store chains. The Australian Health Star Rating (HSR) system was used to quantify the nutritional quality of each bread product. We compared all supermarket’s own brand products to regular brand products, and gluten-free to gluten-containing bread. The mean HSR for the supermarket’s own brands was lower than the regular brands (3.6 vs. 3.7 p = 0.046). For the regular brand products, the fibre, sugar and total fat content were greater (p 0.001, p = 0.002 and p = 0.021, respectively), while less protein (p = 0.009) compared to regular bread products. Gluten-free bread had a lower HSR than gluten-containing bread (mean 3.5 vs. 3.8, respectively p 0.001). The regular brand products were slightly healthier than the supermarket’s own brands, primarily as a result of a higher fibre content. Gluten-free bread products were slightly unhealthier due to a lower protein content.
Publisher: Springer Science and Business Media LLC
Date: 29-04-2015
Publisher: Elsevier BV
Date: 04-2018
Publisher: Elsevier
Date: 2007
Publisher: Springer Science and Business Media LLC
Date: 06-01-2021
DOI: 10.1186/S12937-020-00660-7
Abstract: Consumption of nuts improves cardio-metabolic risk factors in clinical trials and relates to lower risk of cardiovascular disease (CVD) in prospective observational studies. However, there has not been an adequately powered randomized controlled trial to test if nuts supplementation actually reduces incident CVD. In order to establish the feasibility of such a trial, the current study aimed to assess the acceptability and adherence to long-term nut supplementation amongst in iduals at high CVD risk in China. This protocol described a 6-month trial performed in Ningxia Province in China among participants with a history of CVD or older age (female ≥65 years, male ≥60 years) with multiple CVD risk factors. Participants were randomized to control (received non-edible gift), low dose walnut (30 g/d), or high dose walnut (60 g/d) groups in a 1:1:1 ratio. Walnuts were provided at no cost to participants and could be consumed according to personal preferences. Follow-up visits were scheduled at 2 weeks, 3 months and 6 months. The primary outcome was fasting plasma alpha linolenic acid (ALA) levels used as an indicator of walnut consumption. Secondary outcomes included self-reported walnut intake from the 24 h dietary recalls. The target s le size of 210 provided 90% statistical power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in plasma ALA between randomized groups. Two hundred and ten participants were recruited and randomized during October 2019. Mean age of participants was 65 years (SD = 7.3), 47% were females, and 94% had a history of CVD at baseline. Across the three study groups, participants had similar baseline demographic and clinical characteristics. This trial will quantify acceptability and adherence to long-term walnut supplementation in a Chinese population at high risk of CVD. The findings will support the design of a future large trial to test the effect of walnut supplementation for CVD prevention. NCT04037943 Protocol version: v3.0 August 14 2019
Publisher: Springer Science and Business Media LLC
Date: 17-05-2022
Publisher: Elsevier BV
Date: 11-2023
Publisher: Oxford University Press (OUP)
Date: 11-06-2015
Abstract: In this paper we propose replacing the current hypertension control paradigm with a strategy based upon cardiovascular risk management.
Publisher: Springer Science and Business Media LLC
Date: 09-1998
Abstract: The study has been designed to assess the efficacy of blood pressure (BP) reduction in the prevention of stroke in patients with a history of ischaemic stroke, haemorrhagic stroke, or transient ischaemic attack. A randomised, double-blind, placebo-controlled, international, multicentre trial of the angiotensin-converting enzyme (ACE) inhibitor perindopril, alone or in combination with the diuretic indapamide, in the secondary prevention of stroke and other major cardiovascular events. A total of 6000 normotensive or hypertensive patients with a history of stroke or transient cerebral ischaemia within the previous 5 years will be included in the study. The study is being conducted in over 160 centres located in seven regions: Australia and New Zealand The People's Republic of China France and Belgium Italy Japan Sweden and the United Kingdom. The primary study outcome is the total number of strokes defined by WHO criteria. Secondary outcomes include fatal and disabling strokes, total number of cardiovascular events and deaths, cognitive function, disability, and dependency. A minimum of 4 years' follow-up is planned. By 27 March 1997, 173 local clinical centres had been registered in seven regions. A total of 5268 patients (64% with a history of hypertension or baseline BPs above 95 mm Hg [diastolic] or 160 mm Hg [systolic]) had been randomly assigned to active treatment or placebo. After 6 months' follow-up the difference in BP between treatment and control groups was 10.2/4.5 mm Hg (systolic/diastolic). Sixty-three strokes (two fatal) and 20 myocardial infarctions (four fatal) had been recorded. The viability of the study is now assured, with almost 90% of 6000 patients recruited. ACE therapy with perindopril is well tolerated in the studied population. The BP differences between control and treatment groups and the event rates recorded to date suggest that the study will achieve its primary objectives.
Publisher: Wiley
Date: 21-11-2014
DOI: 10.1111/JCH.12442
Publisher: Oxford University Press (OUP)
Date: 07-08-2009
Abstract: Australians currently consume too much salt causing adverse consequences for health. The media play an important role in the provision of nutrition advice to consumers. Previous research shows that many foods advertized in consumer magazines are high in salt, but little research has examined magazine recipes in this context. The aim of this project was to summarize directions for salt use in recipes in leading Australian magazines. In August 2007 and 2008, the top 10 magazines by circulation that included at least five recipes, were examined. Standardized information was collected about directions for salt use in recipes. Three hundred and thirty recipes were identified in 2007 and 417 in 2008. About 68% of recipes included high-salt ingredients, 37% instructed to season with salt, 10% instructed to add a specific quantity of salt and 15% recommended selection of low-salt ingredients. There was substantial variability in directions for salt use in recipes between magazines, but no clear differences between 2007 and 2008. Many recipes advised to add salt in direct contradiction to national dietary guidelines. There is clear potential for editorial guidelines on salt use in recipes to play a role in advancing public health efforts in Australia and other such nations.
Publisher: Oxford University Press (OUP)
Date: 18-10-2017
DOI: 10.1093/IJE/DYW239
Abstract: Spot urine s les are easier to collect than 24-h urine s les and have been used with estimating equations to derive the mean daily salt intake of a population. Whether equations using data from spot urine s les can also be used to estimate change in mean daily population salt intake over time is unknown. We compared estimates of change in mean daily population salt intake based upon 24-h urine collections with estimates derived using equations based on spot urine s les. Paired and unpaired 24-h urine s les and spot urine s les were collected from in iduals in two Australian populations, in 2011 and 2014. Estimates of change in daily mean population salt intake between 2011 and 2014 were obtained directly from the 24-h urine s les and by applying established estimating equations (Kawasaki, Tanaka, Mage, Toft, INTERSALT) to the data from spot urine s les. Differences between 2011 and 2014 were calculated using mixed models. A total of 1000 participants provided a 24-h urine s le and a spot urine s le in 2011, and 1012 did so in 2014 (paired s les n = 870 unpaired s les n = 1142). The participants were community-dwelling in iduals living in the State of Victoria or the town of Lithgow in the State of New South Wales, Australia, with a mean age of 55 years in 2011. The mean (95% confidence interval) difference in population salt intake between 2011 and 2014 determined from the 24-h urine s les was -0.48g/day (-0.74 to -0.21 P < 0.001). The corresponding result estimated from the spot urine s les was -0.24 g/day (-0.42 to -0.06 P = 0.01) using the Tanaka equation, -0.42 g/day (-0.70 to -0.13 p = 0.004) using the Kawasaki equation, -0.51 g/day (-1.00 to -0.01 P = 0.046) using the Mage equation, -0.26 g/day (-0.42 to -0.10 P = 0.001) using the Toft equation, -0.20 g/day (-0.32 to -0.09 P = 0.001) using the INTERSALT equation and -0.27 g/day (-0.39 to -0.15 P 0.058). Separate analysis of the unpaired and paired data showed that detection of change by the estimating equations was observed only in the paired data. All the estimating equations based upon spot urine s les identified a similar change in daily salt intake to that detected by the 24-h urine s les. Methods based upon spot urine s les may provide an approach to measuring change in mean population salt intake, although further investigation in larger and more erse population groups is required.
Publisher: Wiley
Date: 07-03-2023
DOI: 10.1111/DOM.15018
Abstract: To investigate the extent to which improvements in multiple cardiovascular risk markers are associated with a lower risk of cardiovascular and kidney outcomes in patients with type 2 diabetes and high cardiovascular risk participating in the CANVAS programme. Clinically relevant improvements in cardiovascular risk factors were defined as a reduction in glycated haemoglobin ≥1.0%, systolic blood pressure ≥10 mmHg, body weight ≥3 kg, urinary‐albumin‐creatinine ratio ≥30%, uric acid ≥0.5 mg/dl, and an increase in haemoglobin of ≥1.0 g/dl from baseline to week 26. Participants were categorized according to the number of improvements in cardiovascular risk markers: zero, one, two, three, or four or more risk marker improvements. The Cox proportional hazard regression adjusted for treatment assignment, demographic variables and laboratory measurements was performed to determine the association between the number of risk marker improvements and risk of a composite cardiovascular, heart failure or kidney outcomes. We included 9487 (93.5%) participants with available data at baseline and week 26. After week 26, 566 composite cardiovascular, 370 heart failure/cardiovascular death and 153 composite kidney outcomes occurred. The multivariable adjusted hazard ratios associated with four or more improvements in risk markers versus no risk marker improvement were 0.67 (95% CI 0.48, 0.92), 0.58 (95% CI 0.39, 0.87) and 0.49 (95% CI 0.25, 0.96) for the three outcomes respectively. We observed a trend of decreased hazard ratios across subgroups of increasing number of risk marker improvements ( p for trend = .008, .02 and .047, respectively). In patients with type 2 diabetes, improvements in multiple risk markers were associated with a reduced risk of cardiovascular and kidney outcomes as compared with no risk marker improvement.
Publisher: MDPI AG
Date: 20-04-2017
DOI: 10.3390/NU9040404
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2011
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 20-04-2021
Publisher: MDPI AG
Date: 24-07-2019
DOI: 10.3390/NU11081704
Abstract: The US food supply is dominated by highly-processed packaged food and beverage products that are high in energy, saturated fat, sugar, and salt. We report results of a cross-sectional assessment of the 2018 US packaged food and beverage supply by nutritional composition and indicators of healthfulness and level of processing. Data were obtained through Label Insight’s Open Data database, which represents % of all food and beverage products sold in the US over the past three years. Healthfulness and the level of processing, measured by the Health Star Rating (HSR) system and the NOVA classification framework, respectively, were compared across product categories and leading manufacturers. Among 230,156 food and beverage products, the mean HSR was 2.7 (standard deviation (SD) 1.4) from a possible maximum rating of 5.0, and 71% of products were classified as ultra-processed. Healthfulness and level of processing varied substantially by category (range: HSR 1.1–3.9 0–100% ultra-processed) and manufacturer (range: HSR 0.9–4.6 26–100% ultra-processed). The US packaged food and beverage supply is large, heterogeneous, highly processed, and generally unhealthy. The wide variability in healthfulness and level of processing demonstrates that opportunities exist, through reformulation or replacement, for large-scale improvements to the healthfulness of the US packaged food and beverage supply.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-08-2023
DOI: 10.1161/CIRCULATIONAHA.123.065251
Abstract: People with type 2 diabetes and albuminuria are at an elevated risk for cardiac and renal events. The optimal biomarkers to aid disease prediction and to understand the benefits of sodium-glucose cotransporter-2 inhibition remain unclear. Among 2627 study participants in the CREDENCE trial (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation), concentrations of NT-proBNP (N-terminal pro-B-type natriuretic peptide), high-sensitivity cardiac troponin T, growth differentiation factor-15, and IGFBP7 (insulin-like growth factor binding protein 7) were measured. The effect of canagliflozin on biomarker concentrations was evaluated. The prognostic potential of each biomarker on the primary outcome (a composite of end-stage kidney disease [dialysis, transplantation, or a sustained estimated glomerular filtration rate of mL·min −1 ·1.73 m −2 ], doubling of the serum creatinine level, or renal death or cardiovascular death) was assessed. The median (quartiles 1 and 3) concentration of each biomarker was generally elevated: NT-proBNP, 180 ng/L (82, 442 ng/L) high-sensitivity cardiac troponin T, 19 ng/L (12, 29 ng/L) growth differentiation factor-15, 2595 ng/L (1852, 3775 ng/L) and IGFBP7, 121.8 ng/mL (105.4, 141.5 ng/mL). At 1 year, the biomarkers all rose by 6% to 29% in the placebo arm but only by 3% to 10% in the canagliflozin arm (all P .01 in multivariable linear mixed-effect models). Baseline concentrations of each biomarker were strongly predictive of cardiac and renal outcomes. When the biomarkers were analyzed together in a multimarker panel, in iduals with high risk scores (hazard ratio [HR], 4.01 [95% CI, 2.52–6.35]) and moderate risk scores (HR, 2.39 [95% CI, 1.48–3.87]) showed a higher risk for the primary outcome compared with those with low risk scores. By 1 year, a 50% increase in NT-proBNP (HR, 1.11 [95% CI, 1.08–1.15]), high-sensitivity cardiac troponin T (HR, 1.86 [95% CI, 1.64–2.10]), growth differentiation factor-15 (HR, 1.45 [95% CI, 1.24–1.70]), and IGFBP7 (HR, 3.76 [95% CI, 2.54–5.56]) was associated with risk of the primary outcome. Multiple cardiorenal stress biomarkers are strongly prognostic in people with type 2 diabetes and albuminuria. Canagliflozin modestly reduced the longitudinal trajectory of rise in each biomarker. Change in the biomarker level in addition to the baseline level augments the primary outcome prediction. URL: www.clinicaltrials.gov Unique identifier: NCT02065791.
Publisher: American Diabetes Association
Date: 04-2008
DOI: 10.2337/DC07-1657
Abstract: OBJECTIVE—The objective of this study was to describe prevalent vascular retinal lesions among patients with type 2 diabetes enrolled in the ADVANCE Retinal Measurements (AdRem) study, a substudy of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial. RESEARCH DESIGN AND METHODS—Seven-field stereoscopic photographs of both eyes were obtained at the baseline assessment of the ADVANCE trial. All photographs were graded in a central reading center. Gradable retinal images were received from 1,605 patients. RESULTS—The number of patients with any retinopathy (Early Treatment of Diabetic Retinopathy Study [ETDRS] score ≥20) was 645 (40.2% [95% CI 37.8–42.6]) of these, 35 (2.2% [1.6–3.0]) had severe diabetic retinopathy (ETDRS score ≥50). Focal arterial narrowing, venous beading, and arteriovenous nicking were present in 3.8, 5.1, and 9.8% of participants, respectively. Among participants included in this study, Chinese and South-Asian patients had more retinopathy than Caucasians, as defined both by ETDRS score (49.4, 46.0, and 31.3%, respectively P & 0.001, adjusted for age, sex, A1C, systolic blood pressure, and duration of diabetes) and specific vascular lesions (e.g., arteriovenous nicking 12.3, 8.5, and 7.5%, respectively adjusted P & 0.005). A1C, duration of diabetes, and systolic blood pressure were similarly associated with increased retinal lesions in Chinese, South-Asian, and Caucasian patients. CONCLUSIONS—Using a sensitive diagnostic procedure, more than one-third of patients with type 2 diabetes enrolled in the AdRem study had retinal lesions at baseline. Despite differences in prevalence and severity of retinopathy among Chinese, South-Asian, and Caucasian patients included in this study, the cross-sectional associations among established risk factors for retinopathy and retinal lesions were similar across ethnic groups.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2011
Publisher: Elsevier BV
Date: 03-2015
Publisher: Elsevier BV
Date: 11-2020
DOI: 10.1093/CDN/NZAA157
Publisher: AMPCo
Date: 04-2013
DOI: 10.5694/MJA12.10745
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2005
DOI: 10.1161/01.STR.0000181754.38408.4C
Abstract: Background and Purpose— Several prospective studies have shown significant associations between plasma fibrinogen, viscosity, C-reactive protein (CRP), fibrin d -dimer, or tissue plasminogen activator (tPA) antigen and the risk of primary cardiovascular events. Little has been published on the associations of these variables with recurrent stroke. We studied such associations in a nested case-control study derived from the Perindopril Protection Against Recurrent Stroke Study (PROGRESS). Methods— Nested case-control study of ischemic (n=472) and hemorrhagic (n=83) strokes occurring during a randomized, placebo-controlled multicenter trial of perindopril-based therapy in 6105 patients with a history of stroke or transient ischemic attack. Controls were matched for age, treatment group, sex, region, and most recent qualifying event at entry to the parent trial. Results— Fibrinogen and CRP were associated with an increased risk of recurrent ischemic stroke after accounting for the matching variables and adjusting for systolic blood pressure, smoking, peripheral vascular disease, and statin and antiplatelet therapy. The odds ratio for the last compared with the first third of fibrinogen was 1.34 (95% CI, 1.01 to 1.78) and for CRP was 1.39 (95% CI, 1.05 to 1.85). After additional adjustment for each other, these 2 odds ratios stayed virtually unchanged. Plasma viscosity, tPA, and d -dimer showed no relationship with recurrent ischemic stroke, although tPA was significant for lacunar and large artery subtypes. Although each of these variables showed a negative relationship with recurrent hemorrhagic stroke, none of these relationships achieved statistical significance. Conclusions— Fibrinogen and CRP are risk predictors for ischemic but not hemorrhagic stroke, independent of potential confounders.
Publisher: AMPCo
Date: 11-2014
DOI: 10.5694/MJA14.00818
Publisher: Oxford University Press (OUP)
Date: 02-09-2005
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 23-01-2018
DOI: 10.1161/CIRCULATIONAHA.117.032038
Abstract: Canagliflozin is a sodium glucose cotransporter 2 inhibitor that significantly reduces the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients with type 2 diabetes mellitus and elevated cardiovascular risk. The comparative effects among participants with and without a history of cardiovascular disease (secondary versus primary prevention) were prespecified for evaluation. The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) randomly assigned 10 142 participants with type 2 diabetes mellitus to canagliflozin or placebo. The primary prevention cohort comprised in iduals ≥50 years of age with ≥2 risk factors for cardiovascular events but with no prior cardiovascular event, and the secondary prevention cohort comprised in iduals ≥30 years of age with a prior cardiovascular event. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included heart failure hospitalization and a renal composite (40% reduction in estimated glomerular filtration rate, renal replacement therapy, or renal death). Primary prevention participants (N=3486 34%) were younger (63 versus 64 years of age), were more often female (45% versus 31%), and had a longer duration of diabetes mellitus (14 versus 13 years) compared with secondary prevention participants (N=6656 66%). The primary end point event rate was higher in the secondary prevention group compared with the primary prevention group (36.9 versus 15.7/1000 patient-years, P .001). In the total cohort, the primary end point was reduced with canagliflozin compared with placebo (26.9 versus 31.5/1000 patient-years hazard ratio [HR], 0.86 95% confidence interval [CI], 0.75–0.97 P .001 for noninferiority, P =0.02 for superiority) with no statistical evidence of heterogeneity (interaction P value=0.18) between the primary (HR, 0.98 95% CI, 0.74–1.30) and secondary prevention (HR, 0.82 95% CI, 0.72–0.95) cohorts. Renal outcomes (HR, 0.59 95% CI, 0.44–0.79 versus HR, 0.63 95% CI, 0.39–1.02 interaction P value=0.73) and heart failure hospitalization (HR, 0.68 95% CI, 0.51–0.90 versus HR, 0.64 95% CI, 0.35–1.15 interaction P value=0.91) were similarly reduced in the secondary and primary prevention cohorts, respectively. Lower extremity utations were similarly increased in the secondary and primary prevention cohorts (HR, 2.07 95% CI, 1.43–3.00 versus HR, 1.52 95% CI, 0.70–3.29 interaction P value=0.63). Patients with type 2 diabetes mellitus and prior cardiovascular events had higher rates of cardiovascular outcomes compared with the primary prevention patients. Canagliflozin reduced cardiovascular and renal outcomes with no statistical evidence of heterogeneity of the treatment effect across the primary and secondary prevention groups. Additional studies will provide further insights into the effects of canagliflozin in these patient populations. URL: www.clinicaltrials.gov . Unique identifiers: NCT01032629 and NCT01989754.
Publisher: BMJ
Date: 13-10-2013
Publisher: American Diabetes Association
Date: 26-07-2022
DOI: 10.2337/DC21-2398
Abstract: To examine whether the circulating substrate mix may be related to the incidence of heart failure (HF) and cardiovascular (CV) mortality and how it is altered by canagliflozin treatment. We measured fasting glucose, free fatty acids (FFA), glycerol, β-hydroxybutyrate, acetoacetate, lactate, and pyruvate concentrations in 3,581 s les from the CANagliflozin cardioVascular Assessment Study (CANVAS) trial at baseline and at 1 and 2 years after randomization. Results were analyzed by univariate and multivariate Cox proportional hazards models. Patients in the lowest baseline FFA tertile were more often men with a longer duration of type 2 diabetes (T2D), higher urinary albumin excretion, lower HDL-cholesterol levels, higher history of CV disease (CVD), and higher use of statins and insulin. When all seven metabolites were used as predictors, FFA were inversely associated with incident hospitalized HF (hazard ratio [HR] 0.33 [95% CI 0.21–0.55]), while glycerol was a positive predictor (2.21 [1.45–3.35]). In a model further adjusted for 16 potential confounders, including prior HF and CVD and pharmacologic therapies, FFA remained a significant negative predictor. FFA and glycerol also predicted CV mortality (HR 0.53 [95% CI 0.35–0.81] and 1.81 [1.26–2.58], respectively) and all-cause death (0.50 [0.36–0.70] and 1.64 [1.22–2.18]). When added to these models, background insulin therapy was an independent positive predictor of risk of death. Canagliflozin treatment significantly increased plasma FFA and β-hydroxybutyrate regardless of background antihyperglycemic therapy. A constitutive metabolic setup consisting of higher lipolysis may be beneficial in delaying or preventing hospitalized HF a further stimulation of lipolysis by canagliflozin may reinforce this influence.
Publisher: Elsevier BV
Date: 03-2007
DOI: 10.1016/J.IJCARD.2006.03.043
Abstract: Heart attack and stroke are problems already faced by some urban populations of India, but less is known about cardiovascular disease and risk factors in rural areas. The aim of the study was to investigate the levels and management of major cardiovascular risk factors and the prevalence of cardiovascular disease in two villages in rural Andhra Pradesh, India. A cross-sectional survey was done by selecting a random s le stratified by age and gender from each village using census lists compiled in 2002. For each in idual, trained study staff administered a Telugu-translation of a structured questionnaire, performed a brief physical examination and collected a fasting venous blood s le. Weighted estimates of mean (or percentages with) risk factor levels in the population were calculated and are reported with confidence intervals unless otherwise specified. Data was collected from 345 adults aged 20 to 90. The average household size was 4.2 and the mean combined household income was about Indian Rupees 25,454 (580 US dollars) per year. The mean systolic blood pressure was 116 (114-117) mm Hg, diastolic blood pressure 73 (114-120) mm Hg, total cholesterol 4.6 (4.5-4.7) mmol/L, HDL-cholesterol 0.8 (0.8-0.9) mmol/L, LDL-cholesterol 3.2 (3.1-3.3) mmol/L and triglyceride 1.3 (1.2-1.4) mmol/L. The prevalence of current smoking was 19.9% (15.4-24.4%), hypertension 20.3% (16.2-24.4%), diabetes 3.7% (1.8-5.5%), overweight 16.9% (12.3-21.5%) and obesity 4.4% (1.9-6.8%). A medical diagnosis of cardiovascular disease (previous heart attack, stroke or angina) was reported by 2.5% (1.1-3.9%) and a further 1.1% (0.1-2.1%) had angina by the 'Rose' classification. The possibility of increasing cardiovascular risk factors and prevalence of vascular disease in areas of rural India represent a public health concern. Larger and repeated epidemiological studies focusing on chronic diseases are required to inform treatment and prevention strategies suitable for use in these areas and other resource poor settings.
Publisher: American Diabetes Association
Date: 22-09-2022
DOI: 10.2337/DC22-0866
Abstract: The inflammatory cytokine interleukin-6 (IL-6) is associated with cardiovascular (CV) and kidney outcomes in various populations. However, data in patients with type 2 diabetes are limited. We assessed the association of IL-6 with CV and kidney outcomes in the Canagliflozin Cardiovascular Assessment Study (CANVAS) and determined the effect of canagliflozin on IL-6. Patients with type 2 diabetes at high CV risk were randomly assigned to canagliflozin or placebo. Plasma IL-6 was measured at baseline and years 1, 3, and 6. The composite CV outcome was nonfatal myocardial infarction, nonfatal stroke, or CV death the composite kidney outcome was sustained ≥40% estimated glomerular filtration rate decline, end-stage kidney disease, or kidney-related death. Multivariable-adjusted Cox proportional hazards regression was used to estimate the associations between IL-6 and the outcomes. The effect of canagliflozin on IL-6 over time was assessed with a repeated-measures mixed-effects model. The geometric mean IL-6 at baseline, available in 3,503 (80.2%) participants, was 1.7 pg/mL. Each doubling of baseline IL-6 was associated with 14% (95% CI 4, 24) and 21% (95% CI 1, 45) increased risk of CV and kidney outcomes, respectively. Over 6 years, IL-6 increased by 5.8% (95% CI 3.4, 8.3) in the placebo group. Canagliflozin modestly attenuated the IL-6 increase (absolute percentage difference vs. placebo 4.4% [95% CI 1.3, 9.9 P = 0.01]). At year 1, each 25% lower level of IL-6 compared with baseline was associated with 7% (95% CI 1, 22) and 14% (95% CI 5, 22) lower risks for the CV and kidney outcome, respectively. In patients with type 2 diabetes at high CV risk, baseline IL-6 and its 1-year change were associated with CV and kidney outcomes. The effect of IL-6–lowering therapy on CV, kidney, and safety outcomes remains to be tested.
Publisher: Elsevier BV
Date: 09-2016
Publisher: American Diabetes Association
Date: 06-11-2021
DOI: 10.2337/DC20-1889
Abstract: To analyze the association between concentrations of plasma insulin-like growth factor binding protein 7 (IGFBP7) with renal and cardiac outcomes among participants with type 2 diabetes and high cardiovascular risk. Associations between IGFBP7 levels and clinical outcomes were assessed among participants in the Canagliflozin Cardiovascular Assessment Study (CANVAS) with type 2 diabetes and high cardiovascular risk. Among CANVAS participants, 3,577 and 2,898 had IGFBP7 measured at baseline and 1 year, respectively. Per log-unit higher concentration, baseline IGFBP7 was significantly associated with the composite renal end point of sustained 40% reduction in estimated glomerular filtration rate, need for renal replacement therapy, or renal death (hazard ratio [HR] 3.51 P & 0.001) and the composite renal end point plus cardiovascular death (HR 4.90 P & 0.001). Other outcomes, including development or progression of albuminuria, were also predicted by baseline IGFBP7. Most outcomes were improved by canagliflozin regardless of baseline IGFBP7 however, those with baseline concentrations ≥96.5 ng/mL appeared to benefit more from canagliflozin relative to the first progression of albuminuria compared with those with lower baseline IGFBP7 (HR 0.64 vs. 0.95 Pinteraction = 0.003). Canagliflozin did not lower IGFBP7 concentrations by 1 year however, at 1 year, higher IGFBP7 concentrations more strongly predicted the composite renal end point (HR 15.7 P & 0.001). Patients with rising IGFBP7 between baseline and 1 year had the highest number of composite renal events. Plasma IGFBP7 concentrations predicted renal and cardiac events among participants with type 2 diabetes and high cardiovascular risk. More data are needed regarding circulating IGFBP7 and progression of diabetic kidney disease and its complications.
Publisher: Springer Science and Business Media LLC
Date: 18-08-2009
DOI: 10.1007/S00125-009-1484-7
Abstract: The relationship between cognitive function, cardiovascular disease and premature death is not well established in patients with type 2 diabetes. We assessed the effects of cognitive function in 11,140 patients with type 2 diabetes who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Furthermore, we tested whether level of cognitive function altered the beneficial effects of the BP-lowering and glycaemic-control regimens in the trial. Cognitive function was assessed using the Mini Mental State Examination at baseline, and defined by scores 28-30 ('normal', n = 8,689), 24-27 ('mild dysfunction', n = 2,231) and <24 ('severe dysfunction', n = 212). Risks of major cardiovascular events, death and hypoglycaemia and interactions with treatment were assessed using Cox proportional hazards analysis. Relative to normal function, both mild and severe cognitive dysfunction significantly increased the multiple-adjusted risks of major cardiovascular events (HR 1.27, 95% CI 1.11-1.46 and 1.42, 95% CI 1.01-1.99 both p < 0.05), cardiovascular death (1.41, 95% CI 1.16-1.71 and 1.56, 95% CI 0.99-2.46 both p <or= 0.05) and all-cause death (1.33, 95% CI 1.16-1.54 and 1.50, 95% CI 1.06-2.12 both p < 0.03). Severe, but not mild, cognitive dysfunction increased the risk of severe hypoglycaemia (HR 2.10, 95% CI 1.14-3.87 p = 0.018). There was no evidence of heterogeneity of treatment effects on cardiovascular outcomes in subgroups defined by cognitive function at baseline. Cognitive dysfunction is an independent predictor of clinical outcomes in patients with type 2 diabetes, but does not modify the effects of BP lowering or glucose control on the risks of major cardiovascular events. ClinicalTrials.gov NCT00145925.
Location: United Kingdom of Great Britain and Northern Ireland
Location: Australia
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Bruce Neal.