ORCID Profile
0000-0003-3825-4092
Current Organisations
George Institute for Global Health
,
UNSW Sydney
,
Royal Prince Alfred Hospital
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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: Elsevier BV
Date: 05-2005
DOI: 10.1016/J.ANNEPIDEM.2005.01.005
Abstract: Many guidelines advocate measurement of total or low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), and triglycerides (TG) to determine treatment recommendations for preventing coronary heart disease (CHD) and cardiovascular disease (CVD). This analysis is a comparison of lipid variables as predictors of cardiovascular disease. Hazard ratios for coronary and cardiovascular deaths by fourths of total cholesterol (TC), LDL, HDL, TG, non-HDL, TC/HDL, and TG/HDL values, and for a one standard deviation change in these variables, were derived in an in idual participant data meta-analysis of 32 cohort studies conducted in the Asia-Pacific region. The predictive value of each lipid variable was assessed using the likelihood ratio statistic. Adjusting for confounders and regression dilution, each lipid variable had a positive (negative for HDL) log-linear association with fatal CHD and CVD. In iduals in the highest fourth of each lipid variable had approximately twice the risk of CHD compared with those with lowest levels. TG and HDL were each better predictors of CHD and CVD risk compared with TC alone, with test statistics similar to TC/HDL and TG/HDL ratios. Calculated LDL was a relatively poor predictor. While LDL reduction remains the main target of intervention for lipid-lowering, these data support the potential use of TG or lipid ratios for CHD risk prediction.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 18-07-2017
Publisher: Wiley
Date: 11-06-2013
DOI: 10.1111/DOM.12122
Abstract: There is limited evidence regarding the association between physical activity and vascular complications, particularly microvascular disease, in patients with type 2 diabetes. From the 11 140 patients in the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron modified release Controlled Evaluation) trial, the effect of physical activity, categorized as none, mild, moderate or vigorous, and the number of sessions within a week, was examined in multivariable regression models adjusted for potential confounders. The study end-points were major cardiovascular events, microvascular complications and all-cause mortality. Forty-six percent of participants reported undertaking moderate to vigorous physical activity for >15 min at least once in the previous week. During a median of 5 years of follow-up, 1031 patients died, 1147 experienced a major cardiovascular event and 1136 a microvascular event. Compared to patients who undertook no or mild physical activity, those reporting moderate to vigorous activity had a decreased risk of cardiovascular events (HR: 0.78, 95% CI: 0.69-0.88, p < 0.0001), microvascular events (HR: 0.85, 95% CI: 0.76-0.96, p = 0.010) and all-cause mortality (HR: 0.83, 95% CI: 0.73-0.94, p = 0.0044). Moderate to vigorous, but not mild, physical activity is associated with a reduced incidence of cardiovascular events, microvascular complications and all-cause mortality in patients with type 2 diabetes.
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: American Diabetes Association
Date: 12-07-2014
DOI: 10.2337/DC13-2625
Abstract: We investigated microvascular event risk in people with type 2 diabetes and assessed whether N-terminal pro–B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponin T (hsTnT) improved prediction. We performed a case-cohort study, including 439 incident cases of microvascular events (new or worsening nephropathy or retinopathy) and 2,946 noncase subjects identified from participants in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. NT-proBNP and hsTnT were measured in stored plasma s les using automated commercial assays. After adjustment for age, sex, and randomized treatment, the hazard ratios for microvascular events per 1-SD increase in the log-transformed hsTnT and NT-proBNP were 1.67 (95% CI 1.51–1.85) and 1.63 (1.44–1.84), respectively. After further adjustment for classical and diabetes-related cardiovascular disease risk factors, the hazard ratios attenuated to 1.40 (1.24–1.58) and 1.41 (1.24–1.60), respectively. While the C statistic did not improve on addition of hsTnT or NT-proBNP for the total microvascular end point, a combination of both markers improved the prediction of nephropathy (P = 0.033) but not retinopathy (P = 0.72). The corresponding net reclassification indices in a three–risk category model (& %, 10–15%, and & % 5-year risk) for all microvascular events were 7.31% (95% CI 2.24–12.79) for hsTNT addition, 6.23% (1.74–11.5) for NT-proBNP addition, and 7.1% (1.5–12.9) for both markers together. These data suggest that cardiac biomarkers moderately improve microvascular event risk prediction, in particular the risk of nephropathy. Further studies examining the value of this approach for trial design and clinical use are warranted.
Publisher: BMJ
Date: 02-2007
Publisher: Wiley
Date: 14-06-2011
DOI: 10.1111/J.1467-9566.2011.01361.X
Abstract: This article explores Australian general practitioners' (GPs) views on a novel electronic decision support (EDS) tool being developed for cardiovascular disease management. We use Timmermans and Berg's technology-in-practice approach to examine how technologies influence and are influenced by the social networks in which they are placed. In all, 21 general practitioners who piloted the tool were interviewed. The tool occupied an ill-defined middle ground in a dialectical relationship between GPs' routine care and factors promoting best practice. Drawing on Lipsky's concept of 'street-level bureaucrats', the tool's ability to process workloads expeditiously was of greatest appeal to GPs. This feature of the tool gave it the potential to alter the structure, process and content of healthcare encounters. The credibility of EDS tools appears to be mediated by fluid notions of best practice, based on an expert scrutiny of the evidence, synthesis via authoritative guidelines and dissemination through trusted and often informal networks. Balanced against this is the importance of 'soft' forms of knowledge such as intuition and timing in everyday decision-making. This resonates with Aristotle's theory of phronesis (practical wisdom) and may render EDS tools inconsequential if they merely process biomedical data. While EDS tools show promise in improving health practitioner performance, the socio-technical dimensions of their implementation warrant careful consideration.
Publisher: Elsevier BV
Date: 2003
DOI: 10.1067/MHJ.2003.40
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2009
Publisher: Elsevier BV
Date: 11-2014
Publisher: JMIR Publications Inc.
Date: 16-03-2017
DOI: 10.2196/MHEALTH.6889
Publisher: Elsevier BV
Date: 07-2019
Publisher: Wiley
Date: 19-10-2005
DOI: 10.1111/J.1464-5491.2005.01688.X
Abstract: Cardiovascular disease (CVD) rates are substantially higher among patients with Type 2 diabetes than in the general population. The objective of this study was to identify the determinants of carotid intima media thickness (IMT) in patients with Type 2 diabetes. We measured the thickness of the intima media layer of the carotid artery, a strong predictor of the risk of future vascular events, in 397 Type 2 diabetic patients drawn from the Fenofibrate Intervention and Event Lowering in Diabetes study, prior to treatment allocation. The mean IMT was 0.78 mm [interquartile range (IQR) 0.23 mm], and the maximum IMT was 1.17 mm (IQR 0.36 mm). By multivariate analysis, age, sex, duration of diabetes, triglycerides, and total cholesterol were independently correlated with IMT, as was urine albumin-creatinine ratio (ACR) (P 0.65 mg/mmol, approximately one-fifth the standard clinical threshold for microalbuminuria (P < 0.01). Long-term diabetes, independent of other parameters, was associated with a 50% increase in age-related thickening. IMT in people with Type 2 diabetes is independently and continuously related to urine albumin levels and to the duration of diabetes. These results support previous data linking urine albumin measurements within the normal range with increased ischaemic cardiac mortality in the setting of Type 2 diabetes, and strongly suggest that urine albumin levels within this range should trigger a formal evaluation for CVD.
Publisher: American Society of Tropical Medicine and Hygiene
Date: 09-05-2023
Abstract: Lower-middle income Indonesia, the world’s fourth most populous country, has struggled to contain costs in its mandatory, single-payer public health insurance system since the system’s inception in 2014. Public procurement policies radically reduced prices of most medicines in public facilities and the wider market. However, professional associations and the press have questioned the quality of these low-cost, unbranded generic medicines. We collected 204 s les of four cardiovascular and one antidiabetic medicines from health facilities and retail outlets in East Java. We collected amlodipine, captopril, furosemide, simvastatin, and glibenclamide, s ling to reflect patients’ likelihood of exposure to specific brands and outlets. We recorded sales prices and maximum retail prices and tested medicines for dissolution and percentage of labeled content using high-performance liquid chromatography. We conducted in-depth interviews with supply chain actors. All s les, including those provided free in public facilities, met quality specifications. Most manufacturers make both branded and unbranded medicines. Retail prices varied widely. The median ratio of price to the lowest price for an equivalent product was 5.1, and a few brands sold for over 100 times the minimum price. Prices also varied between outlets for identical products because retail pharmacies set prices to maximize profit. Because very-low-cost medicines were universally available and of good quality, we believe richer patients who chose to buy branded products effectively protected medicine quality for poorer patients in Indonesia because manufacturers cross-subsidize between branded and unbranded versions of the same medicine.
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: Public Library of Science (PLoS)
Date: 30-04-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 15-09-2020
Abstract: Internationally, most atrial fibrillation (AF) management guidelines recommend opportunistic screening for AF in people ≥65 years of age and oral anticoagulant treatment for those at high stroke risk (CHA₂DS₂‐VA≥2). However, gaps remain in screening and treatment. General practitioners/nurses at practices in rural Australia (n=8) screened eligible patients (≥65 years of age without AF) using a smartphone ECG during practice visits. eHealth tools included electronic prompts, guideline‐based electronic decision support, and regular data reports. Clinical audit tools extracted de‐identified data. Results were compared with an earlier study in metropolitan practices (n=8) and nonrandomized control practices (n=69). Cost‐effectiveness analysis compared population‐based screening with no screening and included screening, treatment, and hospitalization costs for stroke and serious bleeding events. Patients (n=3103, 34%) were screened (mean age, 75.1±6.8 years 47% men) and 36 (1.2%) new AF cases were confirmed (mean age, 77.0 years 64% men mean CHA₂DS₂‐VA, 3.2). Oral anticoagulant treatment rates for patients with CHA₂DS₂‐VA≥2 were 82% (screen detected) versus 74% (preexisting AF)( P =NS), similar to metropolitan and nonrandomized control practices. The incremental cost‐effectiveness ratio for population‐based screening was AU$16 578 per quality‐adjusted life year gained and AU$84 383 per stroke prevented compared with no screening. National implementation would prevent 147 strokes per year. Increasing the proportion screened to 75% would prevent 177 additional strokes per year. An AF screening program in rural practices, supported by eHealth tools, screened 34% of eligible patients and was cost‐effective. Oral anticoagulant treatment rates were relatively high at baseline, trending upward during the study. Increasing the proportion screened would prevent many more strokes with minimal incremental cost‐effectiveness ratio change. eHealth tools, including data reports, may be a valuable addition to future programs. URL: www.anzctr.org.au . Unique identifier: ACTRN12618000004268.
Publisher: BMJ
Date: 04-2022
DOI: 10.1136/BMJOPEN-2021-053122
Abstract: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent erse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (T P ), initiation of implementation (T 0 ) and 1-year postinitiation (T 1 ). We will extract project-related data from secondary documents at T P and conduct multistakeholder qualitative interviews to gather data at T 0 and T 1. We will undertake descriptive statistical analysis of T P data and analyse T 0 and T 1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.
Publisher: Elsevier BV
Date: 2018
Publisher: BMJ
Date: 09-2015
Publisher: Elsevier BV
Date: 06-2020
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: American Medical Association (AMA)
Date: 17-12-2019
Publisher: Elsevier BV
Date: 12-2017
DOI: 10.1016/J.IJCARD.2017.09.162
Abstract: Fixed dose combinations of cardiovascular therapy ('polypills') have now been launched in several dozen countries. There is considerable clinical interest in the effects of switching to polypill-based care from typical current treatment regimens, especially if polypills contain components at sub-maximal dosage. The SPACE Collaboration includes three trials of polypill based care vs usual care in patients with established CVD or at high calculated risk. In idual patient data for 3140 trial participants were combined. Patients were categorized according to the potency of the statin and the number of BP lowering medications they were taking at baseline. Effects on adherence to anti-platelet medication, systolic blood pressure (SBP) and LDL cholesterol stratified by baseline potency of medication were determined using fixed effects models. Randomisation to the polypill group was associated with improved SBP at 12months, but this improvement varied according to baseline BP regimen: -3.3, -5.9, -2.5 and +1mmHg for patients taking 0, 1, 2 and 3+ BP lowering medications at baseline. For changes in LDL cholesterol at 12months, significant improvements in LDL cholesterol were seen for those taking no statin (-0.21mmol/L 95% CI: -0.34 to -0.07), less potent statin (-0.16mmol/L 95% CI: -0.29 to -0.04) and equipotent statins (-0.14mmol/L 95% CI -0.26 to -0.02) at baseline. The adherence benefits of polypills tend to offset the loss of potency from use of in idual components with lower dose potency, and to facilitate improvements in multiple risk factors.
Publisher: Touch Medical Media, Ltd.
Date: 2009
DOI: 10.17925/USE.2009.05.1.42
Abstract: The world is facing an unprecedented increase in type 2 diabetes. Most disability and premature mortality experienced by patients with diabetes is related to vascular disease and, in particular, macrovascular disease (such as coronary heart disease and stroke) and microvascular disease (such as retinopathy, nephropathy and neuropathy). Indeed, around 1.9 million cardiovascular deaths worldwide are attributable to high blood glucose levels and diabetes, as well as to their associated dangerous companions of high blood pressure and abnormal lipid levels. The global economic costs of diabetes, including foregone economic growth and increasing healthcare expenditure, are substantial and are anticipated to grow. Therefore, strategies to reduce disease burden have continued to focus on reducing cardiovascular risk. Recently, a number of large-scale clinical trials have evaluated approaches for managing cardiovascular risk in patients with type 2 diabetes. Among them the Action in Diabetes and Vascular Disease: PreterAx and DiamicroN MR Controlled Evaluation (ADVANCE) trial has reported the effects of blood pressure lowering and intensive glucose control on major vascular events in patients with established type 2 diabetes. In this article we summarise the findings of the ADVANCE trial and discuss its relevance to the management of cardiovascular risk in patients with type 2 diabetes worldwide.
Publisher: Wiley
Date: 29-11-2018
DOI: 10.1111/DME.13850
Abstract: This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total s le size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional in idual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744 Sri Lanka Clinical Trials Registry No: SLCTR/2017/001 and ClinicalTrials.gov Identifier No: NCT03305939).
Publisher: Springer Science and Business Media LLC
Date: 06-2005
Abstract: The burden of Type II diabetes is growing rapidly worldwide, across high-, middle- and low-income countries. This burden is associated primarily with increased risks of macrovascular and microvascular diseases, and it is agreed that multifactorial treatment regimens are required to reduce it. ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron-MR Controlled Evaluation) is a large-scale, 2 x 2 factorial, randomised clinical trial. It will investigate the potential benefits of blood pressure lowering, using a fixed low-dose combination of perindopril and indapamide vs placebo, and of tighter glucose control, using an intensive gliclazide-MR-based glucose control regimen vs a standard guidelines-based regimen, separately and together. The two primary outcomes are a composite macrovascular end point of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death and a composite microvascular end point of new or worsening nephropathy or microvascular eye disease. Following successful recruitment and randomisation of 11,140 participants by March 2003, the study is currently half way through its planned follow-up of 4.5 years. Adherence to randomised study treatment is good and loss to follow-up is minimal. It is hoped that the study will answer a number of unresolved issues. The blood pressure lowering arm will investigate the possible reduction in major vascular disease in patients with Type II diabetes whether or not they have hypertension, and the possible benefits of blood pressure lowering in such patients already receiving background therapy with the ACE inhibitor perindopril. The glucose control arm will investigate the possible reduction in both macrovascular and microvascular disease achieved with tighter glucose control, targeting an HbA1c of 6.5% and a fasting blood glucose of 6.0 mmol/l. Finally, the factorial design will enable investigation of the combined effects of more intensive glucose control and tighter control of blood pressure.
Publisher: BMJ
Date: 10-2018
DOI: 10.1136/BMJOPEN-2018-023130
Abstract: Screening for atrial fibrillation (AF) in people ≥65 years is now recommended by guidelines and expert consensus. While AF is often asymptomatic, it is the most common heart arrhythmia and is associated with increased risk of stroke. Early identification and treatment with oral anticoagulants can substantially reduce stroke risk. The general practice setting is ideal for opportunistic screening and provides a natural pathway for treatment for those identified. This study aims to investigate the feasibility of implementing screening for AF in rural general practice using novel electronic tools. It will assess whether screening will fit within an existing workflow to quickly and accurately identify AF, and will potentially inform a generalisable, scalable approach. Screening with a smartphone ECG will be conducted by general practitioners and practice nurses in rural general practices in New South Wales, Australia for 3–4 months during 2018–2019. Up to 10 practices will be recruited, and we aim to screen 2000 patients aged ≥65 years. Practices will be given an electronic screening prompt and electronic decision support to guide evidence-based treatment for those with AF. De-identified data will be collected using a clinical audit tool and qualitative interviews will be conducted with selected practice staff. A process evaluation and cost-effectiveness analysis will also be undertaken. Outcomes include implementation success (proportion of eligible patients screened, fidelity to protocol), proportion of people screened identified with new AF and rates of treatment with anticoagulants and antiplatelets at baseline and completion. Results will be compared against an earlier metropolitan study and a ‘control’ dataset of practices. Ethics approval was received from the University of Sydney Human Research Ethics Committee on 27 February 2018 (Project no.: 2017/1017). Results will be disseminated through various forums, including peer-reviewed publication and conference presentations. ACTRN12618000004268 Pre-results.
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: 06-2019
DOI: 10.1016/J.JACC.2019.04.036
Abstract: The burden of cardiovascular (CV) disease is very high in China, due to highly prevalent and poorly controlled risk factors resulting from changing sociodemographic structure and lifestyles in its large population. Rapid economic development and urbanization have been accompanied by changing patterns, expression, and management of CV disease. However, the health care system in China lacks a hierarchical structure, with a focus on treating acute diseases in hospital while ignoring long-term management, and primary health care is too weak to effectively control CV risk factors. To address these challenges, the Chinese central government has ensured health is a national priority and has introduced reforms that include implementing policies for a healthy environment, strengthening primary care, and improving affordability and accessibility within the health system. Turning the inverted pyramid of the health care system is essential in the ongoing battle against CV disease.
Publisher: Elsevier BV
Date: 05-2015
DOI: 10.1016/J.SURG.2015.01.002
Abstract: Information on the use of major surgery in India is scarce. In this study we aimed to bridge this gap by auditing hospital claims from Rajiv Aarogyasri Community Health Insurance Scheme, which provides access to free hospital care through state-funded insurance to 68 million beneficiaries, an estimated 81% of population in the states of Telangana and Andhra Pradesh. Publicly available deidentified hospital claim data for all surgery procedures conducted between mid-2008 and mid-2012 were compiled across all 23 districts in Telangana and Andhra Pradesh. A total of 677,332 operative admissions (80% at private hospitals) were recorded at an annual rate of 259 per 100,000 beneficiaries, with male subjects accounting for 56% of admissions. Injury was the most common cause for operative admission (27%) with operative correction of long bone fractures being the most common procedure (20%) identified in the audit. Diseases of the digestive (16%), genitourinary (12%), and musculoskeletal (10%) systems were other leading causes for operative admissions. Most hospital bed-days were used by admissions for injuries (31%) and diseases of the digestive (17%) and musculoskeletal system (11%) costing 19%, 13%, and 11% of reimbursement. Operations on the circulatory system (8%) accounted for 21% of reimbursements. Annual per capita cost of operative claims was US$1.48. The use of surgery by an insured population in India continued to be low despite access to financing comparable with greater spending countries, highlighting need for strategies, beyond traditional health financing, that prioritize improvement in access, delivery, and use of operative care.
Publisher: Elsevier BV
Date: 09-2021
Publisher: Elsevier BV
Date: 02-2020
Publisher: Elsevier BV
Date: 2014
DOI: 10.1016/J.AHJ.2013.10.002
Abstract: Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk (CVAR) to manage patients. This randomized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk, including prescription of antihypertensive and lipid-lowering medication. A cluster randomized controlled trial was conducted from 2008 to 2010 in Sydney, Australia. Family practices were randomized, and patients aged 45 to 69 years were invited to participate. Intervention family physicians (FP) were trained in use of CVAR, provided with an electronic CVAR calculator, and assessed their patients' absolute risk in a dedicated consultation. Control practice patients received a general health check. Primary outcome analyzed was the proportion of patients in each group on antihypertensive and/or lipid-lowering medication at 12 months. Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy. The study recruited 36 FPs from 34 practices and 1,074 patients, of which 906 (84.4%) completed 12-month follow-up. At 12 months, there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives (31.2% vs 34.3%, P = .31), but control group patients were more likely to be on lipid-lowering medications (30.2% vs 22.7%, P = .01). After multilevel analysis, this difference was not present. Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group. Single-risk factor management remains a strong influence on FP prescribing practices. Shifting to an approach based on CVAR will require more intensive intervention.
Publisher: Wiley
Date: 02-2009
Publisher: Public Library of Science (PLoS)
Date: 14-08-2014
Publisher: Mary Ann Liebert Inc
Date: 11-2005
Abstract: There is much interest in promoting healthy heart awareness among women. However, little is known about the reasons behind the lower rates of heart disease among women compared with men, and why this risk difference diminishes with age. Previous comparative studies have generally had insufficient numbers of women to quantify such differences reliably. We carried out an in idual participant data meta-analysis of 39 cohort studies (32 from Asian countries and 7 from Australia and New Zealand). Cox models were used to estimate hazard ratios (HR) for coronary death, comparing men to women. Further adjustments were made for several proven coronary risk factors to quantify their contributions to the sex differential. Sex interactions were tested for the same risk factors. During 4 million person-years of follow-up, there were 1989 (926 female) deaths from coronary heart disease (CHD). The age-adjusted and study-adjusted male/female HR (95% confidence interval [95% CI]) was 2.05 (1.89-2.22). At baseline, 54% of men vs. 7% of women were current smokers hence, adjustment for smoking explained the largest component (20%) of this HR. A significant sex interaction was observed between systolic blood pressure (SBP) and CHD mortality such that a 10 mm Hg increase was associated with a 15% greater increase in the relative risk (RR) of coronary death in women compared with men (p = 0.002). Only a small amount of the sex differential in coronary death could be explained by differences in the prevalence of classic risk factors. Alternative explanations are required to explain the age-related attenuation of the sex difference in CHD risk.
Publisher: Elsevier BV
Date: 08-2017
DOI: 10.1016/J.IJCARD.2017.03.090
Abstract: Variations in care and outcomes by sex in patients with acute coronary syndrome (ACS) have been reported worldwide. The aims of this study are to describe ACS management according to sex in China and the effects of a quality improvement program in Chinese male and female ACS patients. Clinical Pathways for Acute Coronary Syndromes - Phase 2 (CPACS-2) was a cluster randomized trial to test whether a clinical pathways-based intervention would improve ACS management in China. The study enrolled 15,141 hospitalized patients [4631 (30.6%) were women] from 75 hospitals throughout China between October 2007 and August 2010. The intervention included clinical pathway implementation and performance measurement using standardized indicators with 6 monthly audit-feedback cycles. Eight key performance indicators reflecting in hospital management of ACS were measured. After adjustment for differences in patient characteristics and comorbidities at presentation, women were significantly less likely to undergo coronary angiography when indicated (RR 0.88 [0.85 to 0.92], P<0.001), less likely to receive guideline recommended medical therapies at discharge (RR 0.94 [0.91 to 0.98], P=0.003) and more likely to be hospitalized for shorter (mean difference -0.42 [-0.73 to -0.12] days, P=0.007). However, in-hospital clinical outcomes did not differ by sex. There was no evidence of heterogeneity in the relative effects of the quality improvement initiative by sex. Sex disparities were apparent in some key quality of care indicators for patients with suspected with ACS presenting to hospitals in China. The beneficial effect of the quality improvement program was consistent in women and men. www.anzctr.org.au/default.aspx. Unique identifier: ACTRN12609000491268.
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: Elsevier BV
Date: 02-2007
DOI: 10.1016/J.HLC.2007.04.006
Abstract: Obesity is a risk factor for atrial fibrillation (AF) but the mechanisms underlying this association are unclear. We aimed to assess whether body mass index (BMI) is an independent determinant of left atrial size, in subjects in sinus rhythm. Subjects were consecutive ambulatory patients aged >/=18 years who underwent outpatient transthoracic echocardiography at a major metropolitan teaching hospital in Sydney, Australia. At the time of examination, age, sex, height and weight were measured. Left atrial (LA) area was measured on ultrasound by planimetry. Left ventricular (LV) function and LV posterior wall thickness were measured by M-mode. Of 4859 consecutive subjects who underwent outpatient echocardiography at our institution over a three-year period, we analysed echocardiographic data from 2534 aged >/=18 years with confirmed sinus rhythm, normal LV contractility and no evidence of significant aortic or mitral valve disease. In these subjects (age 47+/-16.6 years, BMI 27.1+/-6.1, 53% male), BMI was a significant predictor of LA size (p<0.001), independent of the significant influences of LV end-diastolic volume and LV posterior wall thickness. Average LA size was 18.5+/-4.0 cm(2) in those with normal BMI, 20.7+/-4.5 cm(2) in the overweight and 22.3+/-4.1cm(2) in obese subjects (p for trend <0.001). Obesity is associated with increased left atrial size in subjects undergoing clinically indicated echocardiography, independent of the effects of left ventricular size and posterior wall thickness. This may contribute, at least in part, to the rising incidence of atrial fibrillation in the community.
Publisher: American Medical Association (AMA)
Date: 05-2019
Publisher: Elsevier BV
Date: 02-2007
Publisher: Elsevier BV
Date: 02-2018
Publisher: OMICS Publishing Group
Date: 12-2012
DOI: 10.4155/CLI.12.127
Publisher: Royal College of Psychiatrists
Date: 22-06-2018
DOI: 10.1192/BJO.2018.28
Abstract: About 10% Indians suffer from stress, depression or substance use disorders. Few receive care for these problems, especially in rural areas. As part of a broader initiative to deliver technology-enabled mental health services for rural communities (adults ≥18 years), information was collected about the prevalence of depression, anxiety and suicide risk. The study was conducted in 12 villages in the West Godavari district of Andhra Pradesh. Depression and anxiety were assessed using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7, respectively. Additionally, data were collected about sociodemographic factors and stressful events, among others. Anxiety, depression and suicidal ideation affected 10.8, 14.4 and 3.5% of participants, respectively ( N = 22 377). These were more common among women, and among those who were aged 30–59 years, uneducated, or orced/ separated/ widowed. Stress due to financial loss was significant. The study identified a significant number of people at risk of depression, anxiety and suicide, and needing care. None.
Publisher: Elsevier BV
Date: 07-2013
DOI: 10.1016/J.HLC.2012.12.013
Abstract: Cardiovascular observational registries characterise patients and describe the manner and use of therapeutic strategies. They facilitate analyses on the quality of care among participating institutions and document variations in clinical practice which can be benchmarked against best practice recommendations. The Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events (CONCORDANCE) is an Australian observational registry that describes management and outcomes in patients with acute coronary syndromes (ACS) and feeds back both performance and outcome measures to participating hospitals. The CONCORDANCE registry has been designed within a comparative effectiveness research (CER) framework to collect and report data from hospitals located in geographically erse regions of Australia. Information including patient demographics, presenting characteristics, past medical history, in-hospital management and outcomes at six months and two years are entered into a web-based database using an electronic clinical record form (eCRF). In idual hospital information is returned to the sites in a real time confidential report detailing information on key performance indicator (KPI) process measures and outcomes benchmarked against the aggregated study cohort. Governance rules ensure data security and protect patient and clinician confidentiality. Consistent with a CER framework, additional characteristics of the registry include: (a) the capacity to evaluate associations between the inter and intra hospital systems and the provision of evidence based care and outcomes, (b) ongoing data collection from representative hospitals which allow spatial and temporal analysis of change in practice and the application of treatment modalities in the real world setting and (c) the provision of a data spine for quality improvement strategies and practical clinical trials. The CONCORDANCE registry is a clinician-driven initiative describing clinical care for ACS patients admitted to Australian hospitals. The registry generates high quality data which is fed back to clinicians, and key stakeholders in ACS care. Using a CER approach, the registry describes the translation of randomised trial evidence into practice, and provides insights into strategies that could improve care and ultimately patient outcomes.
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: 12-2008
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: 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: Elsevier BV
Date: 10-2014
DOI: 10.1016/J.JCHF.2014.04.008
Abstract: This study sought to review the literature for risk prediction models in patients with heart failure and to identify the most consistently reported independent predictors of risk across models. Risk assessment provides information about patient prognosis, guides decision making about the type and intensity of care, and enables better understanding of provider performance. MEDLINE and EMBASE were searched from January 1995 to March 2013, followed by hand searches of the retrieved reference lists. Studies were eligible if they reported at least 1 multivariable model for risk prediction of death, hospitalization, or both in patients with heart failure and reported model performance. We ranked reported in idual risk predictors by their strength of association with the outcome and assessed the association of model performance with study characteristics. Sixty-four main models and 50 modifications from 48 studies met the inclusion criteria. Of the 64 main models, 43 models predicted death, 10 hospitalization, and 11 death or hospitalization. The discriminatory ability of the models for prediction of death appeared to be higher than that for prediction of death or hospitalization or prediction of hospitalization alone (p = 0.0003). A wide variation between studies in clinical settings, population characteristics, s le size, and variables used for model development was observed, but these features were not significantly associated with the discriminatory performance of the models. A few strong predictors emerged for prediction of death the most consistently reported predictors were age, renal function, blood pressure, blood sodium level, left ventricular ejection fraction, sex, brain natriuretic peptide level, New York Heart Association functional class, diabetes, weight or body mass index, and exercise capacity. There are several clinically useful and well-validated death prediction models in patients with heart failure. Although the studies differed in many respects, the models largely included a few common markers of risk.
Publisher: Oxford University Press (OUP)
Date: 08-03-2017
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: Wiley
Date: 12-04-2013
DOI: 10.1111/DME.12181
Abstract: The ADVANCE trial recruited participants from 20 countries worldwide. We analyse here regional variations and causes of hospitalization for people with Type 2 diabetes from Asia, Established Market Economies and Eastern Europe. A cohort analysis examining the effects of region on causes of first hospitalization, and the association of participant characteristics on all-cause first hospitalization across regions, using multivariable (adjusted for clinical, physiological, behavioural and socio-demographic factors) Cox models. Of 11 140 in iduals (6407 men), all-cause hospitalization rates were highest in Established Market Economies, followed by Eastern Europe then Asia. Eastern Europe had rates of hospitalization for diabetic causes four times greater than Established Market Economies [multivariable-adjusted hazard ratio 4.02 (95% CI 2.86-5.63)]. There were no significant regional variations in hospitalization rates for cardiovascular disease (P = 0.534), but much lower rates for musculoskeletal and non-specific causes in Eastern Europe [multivariable-adjusted hazard ratio 0.44 (95% CI 0.32-0.60) and 0.19 (95% CI 0.12-0.29)] and Asia [hazard ratio 0.21 (95% CI 0.16-0.29) and 0.09 (95% CI 0.06-0.14)] compared with Established Market Economies. In all regions, participants hospitalized for any cause were more likely to be older, male, hypertensive, smokers, have higher glycated haemoglobin and a history of macrovascular or macrovascular disease. Across three markedly different regions of the world, regional rates and causes of hospitalization varied widely in patients with Type 2 diabetes. Adjustment for a range of patient characteristics did not explain these regional differences in hospitalization, which appear to be attributable to health system factors.
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: Elsevier BV
Date: 12-2006
DOI: 10.1016/J.DIABRES.2006.03.027
Abstract: To investigate the generalizability of current definitions of the metabolic syndrome in Asia-Pacific populations, and whether information on metabolic risk factors could be better used to discriminate fatal coronary heart disease (CHD) risk. Analyses were performed on in idual participant data from 26 cohorts involving 329, 166 participants from the Asia Pacific region. Sensitivity and specificity estimates for CHD death associated with cut-points as defined by the U.S. National Cholesterol Education Panel (NCEP) were determined for component risk factors of a modified NCEP-defined metabolic syndrome. Five cohorts (6437 subjects, 53 CHD deaths) measuring all five risk factors at baseline were used to evaluate the association between the metabolic syndrome and CHD, and to compare risk discrimination using a definition including each risk factor as a continuous variable. Sensitivity and specificity estimates for risk factor cut-points varied considerably by region (Asia versus Australia/New Zealand) and moderately by sex. The adjusted hazard ratio for CHD death associated with the modified NCEP-defined metabolic syndrome was 2.05 (95%CI, 1.13-3.72). On receiver operator characteristic analysis, the area-under-the-curve for CHD death was 0.586 (95%CI: 0.439-0.732) for the modified NCEP-defined metabolic syndrome, and 0.733, 95%CI: 0.664-0.802) for a definition including each of the metabolic risk factors in their continuous form. Specific cut-points for metabolic risk factors are not generalizable between populations. This finding is not restricted to measures of central obesity. A multivariable definition of the metabolic syndrome including all risk factors as continuous variables improves CHD risk discrimination substantially.
Publisher: Elsevier BV
Date: 03-2009
DOI: 10.1016/J.AHJ.2008.11.016
Abstract: Although cardiovascular absolute risk (CVAR) assessment has been recommended for use in Australian general practice for a number of years, there is continuing uncertainty about its implementation and impact. Our previous work has developed a multifaceted implementation model. This study aims to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care. This cluster randomized controlled trial will be conducted in general practices in Sydney, involving general practitioners (GPs), other practice staff, and patients aged 45 to 69 years without existing cardiovascular disease. A total of 32 practices (40 GPs) and 1,320 patients will be recruited. Randomization will be conducted at the practice level. The intervention group of GPs will be trained to use a CVAR implementation model, whereas the control group of GPs will continue usual care. Study outcomes include clinical processes, patient risk, use of lifestyle intervention, and prescription of antihypertensive and lipid-lowering medications. Data will be collected and analyzed using mixed methods. Study outcomes before and after the intervention will be compared, and the 2 groups will also be compared after adjusting for baseline difference and clustering factors. This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management. Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives.
Publisher: Elsevier BV
Date: 10-2023
Publisher: Public Library of Science (PLoS)
Date: 21-03-2008
Publisher: Springer Science and Business Media LLC
Date: 12-11-2018
Publisher: Oxford University Press (OUP)
Date: 06-2007
Publisher: Springer Science and Business Media LLC
Date: 11-08-2010
Publisher: Elsevier BV
Date: 2021
Publisher: JMIR Publications Inc.
Date: 27-02-2020
DOI: 10.2196/15553
Abstract: Although around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap. This study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among in iduals at high risk of common mental disorders. A before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma c aign, with the training of lay village health workers and primary care doctors to identify and manage in iduals with stress, depression, and suicide risk using an electronic clinical decision support system. In total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7 P .001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 (P .001) and from 12.9 to 1.9 (P .001), respectively. The intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.
Publisher: Georg Thieme Verlag KG
Date: 27-08-2009
Publisher: Frontiers Media SA
Date: 28-11-2016
Publisher: American Medical Association (AMA)
Date: 10-2019
Publisher: Elsevier BV
Date: 02-2014
DOI: 10.1016/J.AHJ.2013.10.020
Abstract: Hypertension management strategies have traditionally focused on "tailored therapy" and "stepped-care" approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill ("Triple Pill") compared with usual care for the management of hypertension. The prospective, open, randomized controlled clinical trial (n = 700) will compare Triple Pill-based strategy to usual care among in iduals with persistent mild-to-moderate hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, or systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg in patients with diabetes or chronic kidney disease) on no or minimal drug therapy. The study will be conducted within approximately 20 hospital-based clinics in India. Participants will be randomized to the Triple Pill (initially strength 1-telmisartan 20 mg, amlodipine 2.5 mg, hydrochlorothiazide 6.25 mg, with the option of subsequent titration to strength 2-telmisartan 40 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg) or continued usual care. Participants will be followed up for 6 months. The primary outcome is the proportion of participants achieving target BP at the end follow-up. This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.
Publisher: Springer Science and Business Media LLC
Date: 23-06-2017
Publisher: Cold Spring Harbor Laboratory
Date: 28-11-2022
DOI: 10.1101/2022.11.27.22282793
Abstract: Gestational Diabetes Mellitus (GDM), once thought to be fully reversed after pregnancy, is now a firmly established independent risk factor for the subsequent development of Type 2 Diabetes Mellitus (T2DM), cardiovascular disease and other chronic conditions. This provides a strong rationale to identify preventive strategies in women with prior GDM, including intervention soon after childbirth. Currently, preventive strategies are mostly focused on modifying lifestyle, with an emphasis on diet and physical activity. However, evidence for the effectiveness of implementing and sustaining changes in behaviour through lifestyle programs is limited, and only a small proportion of women in Australia are thought to engage in lifestyle modification programs. Consideration of additional approaches, including pharmacotherapy, is therefore warranted. The current study aims to 1) measure the prevalence and identify the predictors (up to 4 years post-partum) of persisting dysglycaemia among a erse population of urban Australian women with recent GDM, 2) understand women’s views and views of their healthcare providers on long-term risks of T2DM and barriers and facilitators to engaging in screening and preventive strategies (including pharmacotherapy) to mitigate these risks, and 3) examine the feasibility of a randomised controlled trial of preventive drug therapies in this population. This is a retrospective cohort study with a qualitative sub-study. We will identify GDM-affected women who gave birth between January 2018 and December 2021 in at least three Sydney Hospitals (Liverpool Hospital, Royal Hospital for Women and St George Hospital) and invite them to participate in the study. Eligible participants will complete an online questionnaire and an oral glucose tolerance test to assess their current glycaemic status if they have not done so within 12 months of consent and are not currently pregnant. A subset of participants will be invited to participate in an interview to understand their perspectives of GDM, long-term risks and willingness to take preventive medications (including willingness to participate in trials of preventive medicines). Interviews with healthcare providers will also be conducted to understand their views of long-term diabetes risk, screening, and preventive strategies for women following GDM. This study will help understand post-GDM care gaps and outcomes currently in Australia, as well as inform the design and conduct of future trials of preventive drug therapies in this population. ACTRN12621001618842
Publisher: American Diabetes Association
Date: 13-02-2014
DOI: 10.2337/DB12-1625
Abstract: C-reactive protein (CRP), fibrinogen, and interleukin-6 (IL-6) are associated with cardiovascular disease (CVD) and death in general populations. However, studies of these factors in type 2 diabetes are limited. We studied their associations with the risk of major macrovascular events, microvascular complications, and mortality in patients with type 2 diabetes who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Study. Plasma CRP, fibrinogen, and IL-6 levels were determined in a case-cohort study (n = 3,865) nested within the 11,140 men and women with type 2 diabetes and baseline CVD or risk factors in the ADVANCE Study. All three biomarkers of inflammation were associated with an increased risk of macrovascular events and death in analyses adjusted for age, sex, and treatment groups. After further adjustment, only IL-6 was an independent predictor of macrovascular events (hazard ratio per SD increase 1.37 [95% CI 1.24–1.51]) and death (1.35 [1.23–1.49]). IL-6 significantly improved the prediction of macrovascular events and death. After adjustment, none of the markers predicted microvascular complications. We conclude that IL-6 levels, but not CRP or fibrinogen levels, add significantly to the prediction of macrovascular events and mortality in in iduals with type 2 diabetes who have baseline CVD or risk factors.
Publisher: Wiley
Date: 02-11-2015
Abstract: Recent trials of cardiovascular polypills in high-risk populations show improvements in the use of cardiovascular preventive treatments, compared to usual care. We describe patterns of pill burden in Australian practice, define the impact of polypill therapy on pill burden, and explore how physicians add medication to polypill therapy. The Kanyini Guidelines Adherence with the Polypill Study was an open-label trial involving 623 participants in Australia which randomized participants to a polypill strategy (containing a statin, antiplatelet agent, and two blood-pressure-lowering medications) or usual care. Participants either had established cardiovascular disease or were at high calculated risk (≥15% over 5 years). Current medications, daily pill burden, and self-reported use of combination treatment were recorded prior to randomization and at study end. Median pill burden at baseline and study end was compared in both arms. Subgroup analysis of the polypill strategy on trial primary outcomes was conducted by pill burden at baseline. Median total and cardiovascular pill burdens of the polypill group decreased from 7 to 5 and from 4 to 2, respectively (median change -2 IQR -3, 0), with no change in the usual care group (comparison of change P < 0.001). No change was seen for noncardiovascular medications. Of those still using the polypill at study end, 43.8% were prescribed additional medications 84.5% of these additional medications were blood-pressure-lowering medications. Within the polypill group, lower pill burden at baseline was associated with greater increases in the use of indicated cardiovascular preventive medications at study end compared to those with higher pill burdens. No trend was observed between the level of baseline pill burden and the effect of poylpill treatment on systolic blood pressure or total cholesterol. A cardiovascular polypill in contemporary Australian practice reduces cardiovascular and total pill burdens, despite frequent prescription of additional medications.
Publisher: Public Library of Science (PLoS)
Date: 17-12-2014
Publisher: BMJ
Date: 03-2003
Abstract: Clinical guidelines currently suggest that transthoracic echocardiography (TTE) be carried out in all patients with suspected endocarditis, but the use of TTE where there is a low probability of infective endocarditis has a poor diagnostic yield. This screening approach may no longer be appropriate. To examine whether clinical criteria might aid decision making with respect to the use of TTE in possible endocarditis. A retrospective review of patient records. Cardiology department of a tertiary referral centre. 500 consecutive hospital inpatients referred for TTE to exclude endocarditis. Evidence of endocardial vegetations on TTE and the presence of predetermined clinical criteria that may predispose to, or be suggestive of, endocarditis. Evidence of infective endocarditis was detected on echocardiography in 43 of the 500 patients (8.6%). In 239 patients (48%), vegetations and certain prespecified clinical criteria were both absent. These criteria were: vasculitic/embolic phenomena the presence of central venous access a recent history of injected drug use presence of a prosthetic valve and positive blood cultures. The collective absence of these five criteria indicated a zero probability of TTE showing evidence of endocarditis. The use of simple clinical criteria during the decision making process may avoid many unnecessary TTE examinations in hospital inpatients with a low probability of endocarditis.
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: Elsevier BV
Date: 06-2019
Publisher: Springer Science and Business Media LLC
Date: 29-01-2012
Publisher: Cold Spring Harbor Laboratory
Date: 02-09-2021
DOI: 10.1101/2021.08.31.21262935
Abstract: Influenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease. Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year, but there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomized control trials with larger s le sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates. We aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared to no vaccines or placebo for preventing mortality or cardiovascular disease events in the general population and in populations with pre-existing CVD. Formal ethical review is not required as this study does not need primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings. CRD42021222519. The living systematic review will continually incorporate the latest research findings and keep the synthesized information updated. A prospective meta-analysis will better address this evolving evidence. Safety of influenza vaccines in populations with pre-existing cardiovascular diseases will be studied in particular to complete the current evidence base. Observational studies may affect the overall quality of the study results. We will stratify the analysis by study design and present both randomized and non-randomized results.
Publisher: American Diabetes Association
Date: 27-09-2016
DOI: 10.2337/DC16-1594
Abstract: The burden of vascular diseases remains substantial in patients with type 2 diabetes, requiring identification of further risk markers. We tested the absence of dorsalis pedis and posterior tibial pulses as predictors of major macrovascular and microvascular events, death, and cognitive decline in this population. Data were derived from 11,120 patients with type 2 diabetes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) study. Absent peripheral pulses at baseline were defined as absence of at least one dorsalis pedis or posterior tibial pulse. Absent compared with present peripheral pulses (n = 2,218) were associated with increased 5-year risks for major macrovascular events (hazard ratio 1.47 [95% CI 1.28–1.69], P & 0.0001), myocardial infarction (1.45 [1.13–1.87], P = 0.003), stroke (1.57 [1.23–2.00], P = 0.0003), cardiovascular death (1.61 [1.33–1.95], P & 0.0001), heart failure (1.49 [1.21–1.84], P = 0.0002), all-cause mortality (1.48 [1.29–1.71], P & 0.0001), major microvascular events (1.17 [1.00–1.36], P = 0.04), nephropathy (1.24 [1.00–1.54], P = 0.04), end-stage renal disease or renal death (2.04 [1.12–3.70], P = 0.02), and peripheral neuropathy (1.13 [1.05–1.21], P = 0.0008) after multiple adjustment. Participants with absent dorsalis pedis or posterior tibial pulses had comparable hazard ratios. Risks increased proportionally with the number of absent peripheral pulses, with the highest risks observed in patients with three or four absent pulses. Every additional absent pulse increases the risk of all outcomes. Absent dorsalis pedis and/or posterior tibial pulses are independent predictors of major vascular outcomes in patients with type 2 diabetes. These simple clinical indicators should be used to improve risk stratification and treatment of these patients.
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: 29-11-2012
Abstract: Setting priorities for the prevention and management of heart failure requires an empirical understanding of the pattern of disease burden. We aim to describe the methods for a systematic review of the literature on burden of heart failure in low- and middle-income countries (LMIC) and how this information will be synthesized to produce useful estimates that can inform policy and practice. We will conduct a comprehensive search strategy for articles published between 1995 and April 2012 related to incidence, prevalence and treatment of heart failure in LMIC. Populations will be coded as urban, rural, or combined and studies classified as national, sub-national, healthcare system-based, or community level. Details from eligible studies will be extracted independently by two reviewers using a pre-designed data extraction form that will cover information on demographics, diagnostic criteria including disease incidence and prevalence, medical history, medication history, and hospital- or community-based management and outcomes. We will assess the reporting and methodological quality of the included studies and conduct a quantitative summary of reported outcomes where appropriate. Currently, there are important gaps in our knowledge on the burden of heart failure in LMIC and this systematic review aims to provide useful information that improves our knowledge in this field. Results are expected to be publicly available in early 2013.
Publisher: Elsevier BV
Date: 02-2021
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 15-01-2019
Publisher: Springer Science and Business Media LLC
Date: 12-2014
Publisher: AMPCo
Date: 02-2017
DOI: 10.5694/MJA16.01057
Publisher: Springer Science and Business Media LLC
Date: 25-11-2013
Publisher: American Medical Association (AMA)
Date: 06-2023
DOI: 10.1001/JAMACARDIO.2023.0720
Abstract: Low-dose combination (LDC) antihypertensives consisting of 3 or 4 blood pressure (BP)–lowering drugs have emerged as a potentially important therapy for the initial management of hypertension. To assess the efficacy and safety of LDC therapies for the management of hypertension. PubMed and Medline were searched from date of inception until September 2022. Randomized clinical trials comparing LDC consisting of 3 or 4 BP-lowering drugs compared to either monotherapy, usual care, or placebo. Data were extracted by 2 independent authors and synthesized using both random and fixed-effects models using risk ratios (RR) for binary outcomes and mean differences for continuous outcomes. The primary outcome was mean reduction in systolic BP (SBP) between LDC and monotherapy, usual care, or placebo. Other outcomes of interest included the proportion of patients achieving BP less than 140/90 mm Hg, rates of adverse effects, and treatment withdrawal. Seven trials with a total of 1918 patients (mean [mean range] age, 59 [50-70] years 739 [38%] female) were included. Four trials involved triple-component LDC and 3 involved quadruple-component LDC. At 4 to 12 weeks follow-up, LDC was associated with a greater mean reduction in SBP than initial monotherapy or usual care (mean reduction, 7.4 mm Hg 95% CI, 4.3-10.5) and placebo (mean reduction, 18.0 mm Hg 95% CI, 15.1-20.8). LDC was associated with a higher proportion of participants achieving BP less than 140/90 mm Hg at 4 to 12 weeks compared to both monotherapy or usual care (66% vs 46% RR, 1.40 95% CI, 1.27-1.52) and placebo (54% vs 18% RR, 3.03 95% CI, 1.93-4.77). There was no significant heterogeneity between trials enrolling patients with and without baseline BP-lowering therapy. Results from 2 trials indicated LDC remained superior to monotherapy or usual care at 6 to 12 months. LDC was associated with more dizziness (14% vs 11% RR 1.28, 95% CI 1.00-1.63) but no other adverse effects nor treatment withdrawal. The findings in the study showed that LDCs with 3 or 4 antihypertensives were an effective and well-tolerated BP-lowering treatment option for the initial or early management of hypertension.
Publisher: Springer Science and Business Media LLC
Date: 17-09-2014
DOI: 10.1007/S00125-014-3369-7
Abstract: Data are inconsistent regarding the associations between age, age at diagnosis of diabetes, diabetes duration and subsequent vascular complications. The associations between age (or age at diagnosis), diabetes duration and major macrovascular events, all-cause death and major microvascular events were examined in 11,140 patients with type 2 diabetes randomly allocated to intensive or standard glucose control in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Rates were calculated by 5 year baseline age (or age at diagnosis) and diabetes duration strata. Risks were estimated using Cox models adjusted for treatment assignment and HbA1c. The mean age (±SD) was 65.8 ± 6.4 years, age at diagnosis was 57.8 ± 8.7 years and diabetes duration was 7.9 ± 6.4 years. Diabetes duration was associated with the risk of macrovascular events (HR 1.13 [95% CI 1.08, 1.17]), microvascular events (1.28 [1.23, 1.33]) and death (1.15 [1.10, 1.20]) whereas age (or age at diagnosis) was only associated with the risk of macrovascular events (1.33 [1.27, 1.39]) and death (1.56 [1.48, 1.64]). No interaction was observed between diabetes duration, age and the risk of macrovascular events or death (both p > 0.4). However, an interaction was observed between diabetes duration, age and the risk of microvascular events (p = 0.002), such that the effects of increasing diabetes duration were greatest at younger rather than older age. In patients with type 2 diabetes, age or age at diagnosis and diabetes duration are independently associated with macrovascular events and death whereas only diabetes duration is independently associated with microvascular events and this effect is greater in the youngest patients.
Publisher: Wiley
Date: 23-09-2017
Abstract: The replacement of petrochemical aromatics with bio-based molecules is a key area of current biotechnology research. To date, a small number of aromatics have been produced by recombinant bacteria in laboratory scale while industrial production still requires further strain development. While each study includes some distinct analytical methodology to quantify certain aromatics, a method that can reliably quantify a great number of aromatic products and relevant pathway intermediates is needed to accelerate strain development. In this study, we developed a robust reverse phase high performance liquid chromatography method to quantify a wide range of aromatic metabolites present in host microorganisms using the shikimate pathway, which is the major metabolic pathway for biosynthesis of aromatics. Twenty-three metabolites can be quantified precisely with the optimized method using standard HPLC equipment and UV detection, with the mobile phase used for chromatography also compatible with mass spectrometry (MS). The limit of quantification/detection is as low as 10
Publisher: Informa UK Limited
Date: 03-2009
Abstract: The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial investigated the effects of routine blood pressure lowering and intensive blood glucose control on major vascular events in people with Type 2 diabetes. In this factorial randomized study, 11,140 in iduals with Type 2 diabetes were randomly assigned to a fixed combination of perindopril and indapamide or matching placebo, and to intensive glucose control with the use of modified-release gliclazide plus other drugs required to achieve a hemoglobin A1c of 6.5% of less, or standard guideline-based glucose control. The primary outcomes were composites of major macrovascular and major microvascular events (major vascular events), analyzed jointly and separately. Active treatment in the blood pressure-lowering arm reduced blood pressure by 5.6/2.2 mmHg compared with placebo, and the relative risks of major vascular events, all deaths and cardiovascular deaths by 9% (p = 0.043), 14% (p = 0.025) and 18% (p = 0.027), respectively. These effects appeared independent of the initial blood pressure level or the use of concomitant treatments. Intensive glucose control lowered glycated hemoglobin levels to a mean of 6.5% and reduced the relative risk of major vascular events by 10% (p = 0.01), primarily through a 21% (p = 0.006) reduction in nephropathy. Intensive glucose control was not associated with a significant reduction in macrovascular events however, unlike reports from the recently reported Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, there was no evidence of any increase in all-cause mortality or cardiovascular death with more intensive glucose control. This trial has provided important new evidence with direct implications for clinical management of blood pressure and blood glucose in patients with Type 2 diabetes.
Publisher: Elsevier BV
Date: 10-2023
Publisher: Public Library of Science (PLoS)
Date: 04-02-2013
Publisher: Elsevier BV
Date: 07-2018
DOI: 10.1016/J.IJCARD.2018.03.082
Abstract: The Use of Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial, showed that access to a cardiovascular polypill (aspirin, statin and two blood pressure lowering drugs) significantly improved adherence, lowered systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDLc) in patients with or at high risk of cardiovascular disease (CVD). We aimed to analyze the within-trial cost-effectiveness of the polypill strategy versus usual care in India. Relative effectiveness and costs of polypill versus usual care groups in UMPIRE were estimated from the health sector perspective. Only direct medical costs were considered. The effectiveness of the polypill was reported as a percentage increase in adherence and mean reductions in SBP, and LDL-c, over the 15-month trial period. Healthcare resource utilization and costs were collected for each patient during the trial. Polypill price was constructed using a range of scenarios: $0.06-$0.94/day. The cost-effectiveness of the polypill was measured as the additional cost for 10% increase in adherence, and per unit reduction in SBP and LDL-c. Overall, the mean cost per patient was significantly lower with the polypill strategy (-$203 per person, (95% CI: -286, -119, p < 0.01). In scenario analyses that varied polypill price assumptions, incremental cost-effectiveness ratios for a polypill strategy ranged between cost-saving to $75 per 10% increase in adherence for polypill price of $0.94 per day. The polypill strategy was cost-saving compared to usual care among patients with or at high risk of CVD in India.
Publisher: American Medical Association (AMA)
Date: 11-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2011
Publisher: Elsevier BV
Date: 08-2019
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: Wiley
Date: 15-01-2016
DOI: 10.1111/DOM.12614
Abstract: To formulate a combined cardiovascular risk score in diabetes that could be useful both to physicians and healthcare funders. Data were derived from the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation Observational (ADVANCE-ON) study, a randomized controlled trial (mean duration 5 years) with a post-randomization follow-up (mean 4.9 years), that included 11 140 high-risk patients with diabetes. The outcome analysed was the occurrence of either fatal or non-fatal macrovascular or renal disease. A Cox regression model was used to determine weightings in the risk score. The resultant score was recalibrated to each of three major global regions, as covered by the ADVANCE-ON study. Over a median of 9.9 years, 1145 patients experienced at least one component of the combined outcome event. The resultant score, the AD-ON risk score, incorporated 13 demographic or clinical variables. Its discrimination was modest [c-statistic = 0.668 (95% confidence interval 0.651, 0.685)] but its calibration was excellent (predicted and observed risks coincided well, within disparate global regions). In terms of the integrated discrimination improvement index, its performance was marginally superior, over a 10-year risk horizon, to existing risk scores in clinical use, from a restricted version of the same data, for macrovascular and renal disease separately. The AD-ON risk score has advantages over the existing vascular risk scores in diabetes that used data from the original ADVANCE trial, which treat macrovascular and renal diseases separately. These advantages include its simplicity of use and global application.
Publisher: Springer Science and Business Media LLC
Date: 31-01-2022
Publisher: Oxford University Press (OUP)
Date: 11-03-2009
Abstract: The aim of this study was to investigate serious clinical outcomes associated with atrial fibrillation (AF) and the effects of routine blood pressure lowering on such outcomes in the presence or absence of AF, among in iduals with type 2 diabetes. About 11 140 patients with type 2 diabetes (7.6% of whom had AF at baseline) were randomized to a fixed combination of perindopril and indapamide or placebo in the Action in Diabetes and Vascular Disease: preterAx and diamicroN-MR Controlled Evaluation (ADVANCE) study. We compared total mortality and cardiovascular disease outcomes and effects of randomized treatment for 4.3 years on such outcomes between patients with and without AF at baseline. After multiple adjustments, AF was associated with a 61% (95% confidence interval 31-96, P < 0.0001) greater risk of all-cause mortality and comparable higher risks of cardiovascular death, stroke, and heart failure (all P < 0.001). Routine treatment with a fixed combination of perindopril and indapamide produced similar relative, but greater absolute, risk reductions for all-cause and cardiovascular mortalities in patients with AF, compared with those without AF. The number of patients needed to be treated with perindopril-indapamide for 5 years to prevent one cardiovascular death was 42 for patients with AF and 120 for patients without AF at baseline. Atrial fibrillation is relatively common in type 2 diabetes and is associated with substantially increased risks of death and cardiovascular events in patients with type 2 diabetes. This arrhythmia identifies in iduals who are likely to obtain greater absolute benefits from blood pressure-lowering treatment. Atrial fibrillation in diabetic patients should be regarded as a marker of particularly adverse outcome and prompt aggressive management of all risk factors.
Publisher: Springer Science and Business Media LLC
Date: 15-08-2017
Publisher: AMPCo
Date: 09-2009
DOI: 10.5694/J.1326-5377.2009.TB02811.X
Abstract: To describe cardiovascular disease (CVD) risk management in Indigenous primary health care. Review of 1165 randomly selected case records of Indigenous Australian adults, aged >/= 18 years, regularly attending eight health services in erse settings in New South Wales, Queensland and Central Australia, October 2007 - May 2008. Adherence to CVD risk screening and management guidelines, especially with respect to overall or absolute CVD risk. More than half the people in the s le (53%) were not adequately screened for CVD risk according to national recommendations. Underscreening was significantly associated with younger age, less frequent attendance, and lower uptake of the Medicare Health Assessment. Of the s le, 9% had established CVD, and 29% of those aged >/= 30 years were classified as high risk according to the 2004 National Heart Foundation of Australia (NHFA) adjusted Framingham equation. Of those with CVD, 40% (95% CI, 30%-50%) were not prescribed a combination of blood pressure (BP) medicines, statins and antiplatelet agents, and 56% (95% CI, 49%-62%) of high-risk in iduals without CVD were not prescribed BP medicines and statins. For high-risk in iduals not prescribed BP medicines or statins, 74% (95% CI, 64%-84%) and 30% (95% CI, 23%-39%) respectively, did not meet 2004 NHFA criteria for prescribing of these medications, and of those already prescribed BP medicines or statins, 41% (95% CI, 36%-47%) and 59% (95% CI, 52%-66%) did not meet respective guideline targets. These management gaps are similar to those found in non-Indigenous health care settings, suggesting deficiencies across the health system. Prescribing guidelines which exclude many high-risk in iduals contribute to suboptimal management. Guideline reform and improved health service capacity could substantially improve Indigenous vascular health.
Publisher: JMIR Publications Inc.
Date: 08-12-2014
DOI: 10.2196/MHEALTH.3568
Publisher: Springer Science and Business Media LLC
Date: 12-2019
DOI: 10.1186/S12916-019-1463-X
Abstract: Evaluation of health technology programmes should be theoretically informed, interdisciplinary, and generate in-depth explanations. The NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework was developed to study unfolding technology programmes in real time—and in particular to identify and manage their emergent uncertainties and interdependencies. In this paper, we offer a worked ex le of how NASSS can also inform ex post (i.e. retrospective) evaluation. We studied the TORPEDO (Treatment of Cardiovascular Risk in Primary Care using Electronic Decision Support) research programme, a multi-faceted computerised quality improvement intervention for cardiovascular disease prevention in Australian general practice. The technology ( HealthTracker ) had shown promise in a cluster randomised controlled trial (RCT), but its uptake and sustainability in a real-world implementation phase was patchy. To explain this variation, we used NASSS to undertake secondary analysis of the multi-modal TORPEDO dataset (results and process evaluation of the RCT, survey responses, in-depth professional interviews, videotaped consultations) as well as a s le of new, in-depth narrative interviews with TORPEDO researchers. Ex post analysis revealed multiple areas of complexity whose influence and interdependencies helped explain the wide variation in uptake and sustained use of the HealthTracker technology: the nature of cardiovascular risk in different populations, the material properties and functionality of the technology, how value (financial and non-financial) was distributed across stakeholders in the system, clinicians’ experiences and concerns, organisational preconditions and challenges, extra-organisational influences (e.g. policy incentives), and how interactions between all these influences unfolded over time. The NASSS framework can be applied retrospectively to generate a rich, contextualised narrative of technology-supported change efforts and the numerous interacting influences that help explain its successes, failures, and unexpected events. A NASSS-informed ex post analysis can supplement earlier, contemporaneous evaluations to uncover factors that were not apparent or predictable at the time but dynamic and emergent.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 18-07-2012
DOI: 10.2106/JBJS.L.00274
Abstract: Although modern clinical trials are traditionally conducted in Western countries, currently there is a shift to involve developing countries, particularly China and India. For these trials, the large population size of India and China means that substantial numbers of in iduals affected by rare diseases may be found, increasing the likelihood of successfully completing enrollment in a clinical trial. Furthermore, the increasing involvement of Asian countries in global clinical trials is likely to lead to greater appreciation of the value of evidence-based treatment decisions in the region. These sites are more cost-effective, although this advantage is being eroded over time. Asian participants in clinical trials are also typically more likely to complete study follow-up and procedures, and to adhere to their randomized treatment allocation than in iduals from Western countries. Challenges include relevance of the proposed trial to the region, capacity limitations because of undeveloped training, and ensuring research implementation quality and different intellectual property practices. There are specific challenges to conducting clinical trials in India, such as the status of ethics committees, health insurance and coverage for participants, and variability in languages and record-keeping. Challenges in both countries are substantial but are able to be managed with appropriate planning.
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: Wiley
Date: 22-11-2022
DOI: 10.1002/HCS2.26
Publisher: Elsevier BV
Date: 10-2012
DOI: 10.1016/J.MIMET.2012.08.003
Abstract: An in situ high throughput method for the detection of H(2)S during fermentation was developed. The method utilizes a redox reaction in which sulfide ion reduces methylene blue, leading to its decolourisation. Incorporation of methylene blue into the fermentation media allows real-time detection of H(2)S during fermentation and the generation of an H(2)S production profile. Kinetic parameters extracted from the H(2)S production profile can be used to characterise genetic factors affecting H(2)S production and differentiate between environmental conditions affecting it. The method, validated here for Saccharomyces cerevisiae, is suited for high throughput screening purposes by virtue of its simplicity and the ability to detect H(2)S in micro-scale fermentations.
Publisher: Springer Science and Business Media LLC
Date: 22-03-2023
DOI: 10.1186/S40545-022-00509-W
Abstract: In Indonesia, the world's fourth most populous country, cardiovascular diseases (CVDs) are a leading cause of death and disability. Government efforts to reduce the burden of CVD include a community-based prevention and early detection programme, and the provision of medicines to prevent cardiovascular events. Disruptions to medicine supply chains, service provision, and movement during the COVID-19 pandemic potentially threatened the continuity of these efforts. We investigated the distribution and dispensing of common CVD medicines in Malang district, East Java, before the pandemic and early in its course. From January to October 2020, we collected monthly data on stock levels, sales or dispensing volumes, and price for five common CVD medicines (amlodipine, captopril, furosemide, glibenclamide and simvastatin), from a public and a private distributor, and from public health facilities ( n = 4) and private pharmacies ( n = 2). We further complied monthly data on patient numbers in two primary health centres. We tracked changes in stocks held and volumes dispensed by medicine type and sector, comparing the three months before the local COVID-19 response was mobilised with the subsequent seven months. We conducted interviews with pharmacists ( n = 12), community health workers ( n = 2) and a supply chain logistics manager to investigate the reasons for observed changes, and to learn details of any impacts or mitigation measures. The pandemic affected demand more than supply, causing medicine stocks to rise. Restricted service provision, lock-down measures and fear of infection contributed to a sharp drop in patient numbers and dispensing volumes in the public sector. Meanwhile private sector sales, especially of lower-priced CVD medicines, rose. Community health workers attributed some poor health outcomes to interruption in regular patient check-ups this interruption was aggravated by formal mitigation policies. Fears that COVID-19 would interrupt medicine availability were unfounded in East Java. Public sector patients may have compensated for reduced service access by switching to private pharmacies. Mitigation policies that ignored administrative procedures were not effective.
Publisher: Public Library of Science (PLoS)
Date: 14-09-2016
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2010
Publisher: JMIR Publications Inc.
Date: 19-07-2019
Abstract: lthough around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap. his study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among in iduals at high risk of common mental disorders. before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma c aign, with the training of lay village health workers and primary care doctors to identify and manage in iduals with stress, depression, and suicide risk using an electronic clinical decision support system. n total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7 i P /i & .001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 ( i P /i & .001) and from 12.9 to 1.9 ( i P /i & .001), respectively. he intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.
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: 03-01-2012
DOI: 10.1136/HEARTJNL-2011-300957
Abstract: Cardiovascular diseases (CVDs) are the leading cause of death among adult women in many parts of India and a major cause of morbidity. In some parts of the world, gender inequities have been observed in cardiovascular healthcare and cardiovascular outcomes. The authors discuss the data for potential disparities in cardiovascular healthcare for women in India. Data on cardiovascular healthcare provision and CVD outcomes among women in India are generally lacking. The little available data suggest that women in rural areas, younger women and girl children with CVD are less likely to receive appropriate management than men, with this disparity most apparent in those of lower socioeconomic status and education. However, there is a particular lack of information about the prevention and management of atherosclerotic heart disease in women from a range of communities that comprise the extremely erse population of India.
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: Elsevier BV
Date: 03-2015
DOI: 10.1016/J.AHJ.2014.12.005
Abstract: Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS.
Publisher: AMPCo
Date: 27-06-2020
DOI: 10.5694/MJA2.50667
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: Public Library of Science (PLoS)
Date: 29-12-2015
Publisher: American Chemical Society (ACS)
Date: 18-07-2017
Abstract: Functional oxide interfaces have received a great deal of attention owing to their intriguing physical properties induced by the interplay of lattice, orbital, charge, and spin degrees of freedom. Atomic-scale precision growth of the oxide interface opens new corridors to manipulate the correlated features in nanoelectronics devices. Here, we demonstrate that both head-to-head positively charged and tail-to-tail negatively charged BiFeO
Publisher: American Medical Association (AMA)
Date: 04-09-2013
Publisher: Elsevier BV
Date: 11-2023
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: Elsevier BV
Date: 04-2023
Publisher: BMJ
Date: 06-2022
DOI: 10.1136/BMJOPEN-2022-061548
Abstract: Current treatments for chronic musculoskeletal (MSK) pain are suboptimal. Discovery of robust prognostic markers separating patients who recover from patients with persistent pain and disability is critical for developing patient-specific treatment strategies and conceiving novel approaches that benefit all patients. Given that chronic pain is a biopsychosocial process, this study aims to discover and validate a robust prognostic signature that measures across multiple dimensions in the same adolescent patient cohort with a computational analysis pipeline. This will facilitate risk stratification in adolescent patients with chronic MSK pain and more resourceful allocation of patients to costly and potentially burdensome multidisciplinary pain treatment approaches. Here we describe a multi-institutional effort to collect, curate and analyse a high dimensional data set including epidemiological, psychometric, quantitative sensory, brain imaging and biological information collected over the course of 12 months. The aim of this effort is to derive a multivariate model with strong prognostic power regarding the clinical course of adolescent MSK pain and function. The study complies with the National Institutes of Health policy on the use of a single internal review board (sIRB) for multisite research, with Cincinnati Children’s Hospital Medical Center Review Board as the reviewing IRB. Stanford’s IRB is a relying IRB within the sIRB. As foreign institutions, the University of Toronto and The Hospital for Sick Children (SickKids) are overseen by their respective ethics boards. All participants provide signed informed consent. We are committed to open-access publication, so that patients, clinicians and scientists have access to the study data and the signature(s) derived. After findings are published, we will upload a limited data set for sharing with other investigators on applicable repositories. NCT04285112 .
Publisher: BMJ
Date: 12-2020
DOI: 10.1136/BMJOPEN-2020-037774
Abstract: The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes re-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective. The Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive s ling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders. Ethics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India University of Sydney, New South Wales, Australia and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops. Clinical Trials Registry of India (CTRI/2017/06/008744) Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry ( NCT03305939 ) Pre-results.
Publisher: American Medical Association (AMA)
Date: 06-2015
DOI: 10.1001/JAMADERMATOL.2014.3593
Abstract: The total cost of psoriasis in the United States is unknown. Defining the US economic burden of psoriasis is needed because it provides the foundation for research, advocacy, and educational efforts. To determine the US economic burden of psoriasis from a societal perspective. PubMed and MEDLINE databases were searched between January 1, 2008, and September 20, 2013, for economic investigations on the direct, indirect, intangible, and comorbidity costs of adult psoriasis in the United States. The base year costs were adjusted to 2013 US dollars using the Consumer Price Index for All Urban Consumers and multiplied by the estimated number of US patients with psoriasis in 2013 to determine the 2013 psoriasis cost burden. Among 100 identified articles, 22 studies were included in the systematic review. The direct psoriasis costs ranged from $51.7 billion to $63.2 billion, the indirect costs ranged from $23.9 billion to $35.4 billion, and medical comorbidities were estimated to contribute $36.4 billion annually in 2013 US dollars. Patients with psoriasis would pay a lifetime cost of $11,498 for relief of physical symptoms and emotional health however, intangible cost data are limited. The annual US cost of psoriasis amounted to approximately $112 billion in 2013. The economic burden of psoriasis is substantial and significant in the United States.
Publisher: Springer Science and Business Media LLC
Date: 12-2017
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: 07-2022
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-10-2017
Abstract: We evaluated a multifaceted, computerized quality improvement intervention for management of cardiovascular disease ( CVD ) risk in Australian primary health care. After completion of a cluster randomized controlled trial, the intervention was made available to both trial arms. Our objective was to assess intervention outcomes in the post‐trial period and any heterogeneity based on original intervention allocation. Data from 41 health services were analyzed. Outcomes were (1) proportion of eligible population with guideline‐recommended CVD risk factor measurements and (2) the proportion at high CVD risk with current prescriptions for guideline‐recommended medications. Patient‐level analyses were conducted using generalized estimating equations to account for clustering and time effects and tests for heterogeneity were conducted to assess impact of original treatment allocation. Median follow‐up for 22 809 patients (mean age, 64.2 years 42.5% men, 26.5% high CVD risk) was 17.9 months post‐trial and 35 months since trial inception. At the end of the post‐trial period there was no change in CVD risk factor screening overall when compared with the end of the trial period (64.7% versus 63.5%, P =0.17). For patients at high CVD risk, there were significant improvements in recommended prescriptions at end of the post‐trial period when compared with the end of the trial period (65.2% versus 56.0%, P .001). There was no heterogeneity of treatment effects on the outcomes based on original randomization allocation. CVD risk screening improvements were not observed in the post‐trial period. Conversely, improvements in prescribing continued, suggesting that changes in provider and patient actions may take time when initiating medications. URL : www.anzctr.org.au . Unique identifier: 12611000478910.
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: Elsevier BV
Date: 08-2016
Publisher: Public Library of Science (PLoS)
Date: 25-05-2011
Publisher: Public Library of Science (PLoS)
Date: 26-03-2019
Publisher: BMJ
Date: 2013
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2019
Publisher: BMJ
Date: 12-04-2006
Abstract: Background: There is concern about whether cardiac damage occurs as a result of prolonged strenuous exercise. Objective: To investigate whether competing in a triathlon is associated with cardiac damage based on a sustained increase in cardiac troponin T (cTnT), and whether such an increase correlates with echocardiographic changes Methods: cTnT and echocardiographic measurements were made in 38 participants in the 2001 Australian ironman triathlon. cTnT was measured the day before, immediately after, and the day following the race. Echocardiography was done the day before, immediately after, and two to six weeks later for measurement of ejection fraction, stroke volume, cardiac output, wall motion analysis, and global left ventricular function (LVF). Results: No subject had detectable cTnT in the pre-race s le. Following the race, 32 subjects (86.5%) had detectable levels of cTnT ( .01 ng/ml), with six (16.2%) having .10 ng/ml. The day after the race, nine subjects (23.7%) still had detectable cTnT, with two recording a level .10 ng/ml. Previously described echocardiographic changes of “cardiac fatigue” were observed in the whole cohort. There was a modest but significant correlation between change in ejection fraction and peak cTnT level (p = 0.02, r = 0.39). Athletes with a post-race cTnT .10 ng/ml had a greater decrease in global LVF (p = 0.02) and a trend toward a greater fall in ejection fraction and stroke volume than athletes with cTnT levels .10 ng/ml. Cardiac output fell in the group with cTnT .10 ng/ml (p .05). Conclusions: Participation in ironman triathlon often resulted in persistently raised cTnT levels, and the troponin rise was associated with echocardiographic evidence of abnormal left ventricular function. The clinical significance and long term sequelae of such damage remains to be determined.
Publisher: BMJ
Date: 07-2021
DOI: 10.1136/BMJGH-2021-005003
Abstract: Digital health interventions (DHIs) have huge potential as support modalities to identify and manage cardiovascular disease (CVD) risk in resource-constrained settings, but studies assessing them show modest effects. This study aims to identify variation in outcomes and implementation of SMARTHealth India, a cluster randomised trial of an ASHA-managed digitally enabled primary healthcare (PHC) service strengthening strategy for CVD risk management, and to explain how and in what contexts the intervention was effective. We analysed trial outcome and implementation data for 18 PHC centres and collected qualitative data via focus groups with ASHAs (n=14) and interviews with ASHAs, PHC facility doctors and fieldteam mangers (n=12) Drawing on principles of realist evaluation and an explanatory mixed-methods design we developed mechanism-based explanations for observed outcomes. There was substantial between-cluster variation in the primary outcome (overall: I 2 =62.4%, p =0.001). The observed heterogeneity in trial outcomes was not attributable to any single factor. Key mechanisms for intervention effectiveness were community trust and acceptability of doctors’ and ASHAs’ new roles, and risk awareness. Enabling local contexts were seen to evolve over time and in response to the intervention. These included obtaining legitimacy for ASHAs’ new roles from trusted providers of curative care ASHAs’ connections to community and to qualified providers their responsiveness to community needs and the accessibility, quality and appropriateness of care provided by higher level medical providers, including those outside of the implementing (public) subsystem. Local contextual factors were significant influences on the effectiveness of this DHI-enabled PHC service strategy intervention. Local adaptions need to be planned for, monitored and responded to over time. By identifying plausible explanations for variation in outcomes between clusters, we identify potential strategies to strengthen such interventions.
Publisher: Oxford University Press (OUP)
Date: 17-11-2021
Publisher: Elsevier BV
Date: 03-2015
DOI: 10.1016/J.IJCARD.2014.12.087
Abstract: Early detection of changes in cardiac structure and function associated with type 2 diabetes (T2DM) is important. However when multiple abnormalities are present, combining in idual measurements can be subjective. This study sought to create a simple echo score that summarises measurements that may detect early and prognostically important changes in cardiac function. Standard echocardiography was performed on 849 people with T2DM (median age 65years, 40% female, median duration of diabetes 5.5years). Principal components analysis was performed on measurements of LV mass, LA volume, E:e', and s', to create an objective summary score. The score was included in two Cox proportional hazard models adjusted for CV risk factors: one estimated the development of heart failure (HF) and the second estimated any CV event. The first two principal components represented 75% of the variation between the four echo measurements. A continuous score that represents the residual difference between these two components was derived that only requires measurement of medial E:e' and s'. The score was significantly associated with the development of HF within four years (hazard ratio 1.34 95% CI 1.15, 1.56). We have developed a simple, objective score that enhances the use of echocardiography in the detection of sub-clinical cardiac disease in people with T2DM. Initial findings suggest that it may help identify those at increased risk of developing HF within four years.
Publisher: Wiley
Date: 06-04-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2015
DOI: 10.1161/CIRCOUTCOMES.115.001483
Abstract: This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention. In-depth, semistructured interviews (n=94) were conducted with health providers and patients from Australian general practice, Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic randomized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention. Interview topics included polypill strategy acceptability, factors affecting adherence, and trial implementation. Transcribed interview data were analyzed thematically and interpretively. Polypill patients commented frequently on cost-savings, ease, and convenience of a daily-dosing pill. Most providers considered a polypill strategy to facilitate improved patient medication use. Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden. Providers noted the inflexibility of the fixed dose regimen, with dosages sometimes inappropriate for patients with complex management considerations. Future polypill formulations with varied strengths and classes of medications may overcome this barrier. Many providers suggested the polypill strategy, in its current formulations, might be more suited to high-risk primary prevention patients. The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention. Limitations to provider acceptability of this particular polypill were revealed, as was a perception it might be more suitable for high-risk primary prevention patients, though future combinations could facilitate its use in secondary prevention. Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden in indigenous populations. URL: www.anzctr.org.au . ANZCTRN: 12608000583347.
Publisher: Springer Science and Business Media LLC
Date: 25-09-2007
DOI: 10.1007/S00125-007-0801-2
Abstract: The aim of this study was to assess the association between total cholesterol and major cardiovascular diseases among persons with and without diabetes in the Asia-Pacific region. We used data on in idual participants in 30 cohort studies from the Asia-Pacific region to compute the hazards ratios and 95% CIs for participants with and without diabetes at baseline, using Cox proportional models. Analyses were stratified by sex and region (Asia vs Australia or New Zealand) and adjusted for age. Repeat measurements of total cholesterol were used to adjust for regression dilution bias. The analysis included 333,533 in iduals (6.3% with diabetes at baseline) who experienced 6,074 fatal and non-fatal cardiovascular events over a median follow-up period of 4.0 years. Total cholesterol was positively associated with coronary heart disease (CHD) and ischaemic stroke, and negatively with haemorrhagic stroke in a continuous, log-linear fashion, similarly among participants with and without diabetes. Each 1 mmol/l increase above the 'usual' level for total cholesterol was associated with a 41% (95% CI 23-63%) and 42% (95% CI 35-50%) greater risk of CHD among participants with and without diabetes. The corresponding values for ischaemic stroke were 23% (95% CI 0-52%) and 31% (95% CI 20-44%), respectively. These results were broadly consistent for sex, age and region. Total cholesterol is associated with similarly increased risks of cardiovascular events in people with and without diabetes. While abnormal levels of other lipid fractions are frequently observed in people with diabetes, these data support aggressive lowering of total cholesterol and LDL-cholesterol levels for prevention of cardiovascular events.
Publisher: Oxford University Press (OUP)
Date: 24-05-2005
DOI: 10.1093/IJE/DYI104
Abstract: Although smoking is a major risk factor for cardiovascular disease, it has been suggested that Asians may be less susceptible to the adverse effects of smoking than Caucasians. This may have contributed to the high prevalence of smoking, and the low quitting rates, in Asian men. Worldwide, smoking rates are increasing for women, amongst whom cardiovascular awareness is relatively poor. An in idual participant data analysis of 40 cohort studies was carried out, involving 463 674 Asians (33% female) and 98 664 Australasians (45% female). Cox proportional hazard models, stratified by study and sex where appropriate, were employed. The HR [95% confidence interval (CI)], comparing current smokers with non-smokers, for coronary heart disease (CHD) was 1.60 (1.49-1.72) haemorrhagic stroke 1.19 (1.06-1.33) ischaemic stroke 1.38 (1.24-1.54). There was a clear dose-response relationship between the number of cigarettes smoked per day and both CHD and stroke, with no significant difference (P >/= 0.20) between populations from Asia and Australia/New Zealand. Although there was no sex difference for stroke in the effect of amount smoked (P = 0.16), for CHD, women tended to have higher hazard ratios than men (P = 0.011). Quitting gave a clear benefit, which was not significantly different between the sexes or regions (P > 0.63). The HR (CI) for ex-smokers compared with current smokers was 0.71 (0.64-0.78) for CHD and 0.84 (0.76-0.92) for stroke. Unless urgent public health measures are put into place, the impact of the smoking epidemic in Asia, and among women, will be enormous. Tobacco control policies that specifically target these populations are essential.
Publisher: Springer Science and Business Media LLC
Date: 08-02-2021
DOI: 10.1186/S13033-021-00438-2
Abstract: Globally, mental health problems are a growing public health concern. Resources and services for mental disorders are disproportionately low compared to disease burden. In order to bridge treatment gaps, The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Project was implemented across 12 villages in West Godavari district of the southern Indian state of Andhra Pradesh. This paper reports findings from a process evaluation of feasibility and acceptability of the intervention that focused on a mental health services delivery model to screen, diagnose and manage common mental disorders (CMDs). A mixed methods evaluation was undertaken using quantitative service usage analytics, and qualitative data from in-depth interviews and focus group discussions were conducted with stakeholders including primary care physicians, community health workers, field staff and community members. Barriers to and facilitators of intervention implementation were identified. Andersen’s Behavioral Model for Health Services Use was the conceptual framework used to guide the process evaluation and interpretation of data. In all, 41 Accredited Social Health Activists (ASHAs) and 6 primary health centre (PHC) doctors were trained in mental health symptoms and its management. ASHAs followed up 98.7% of screen positive cases, and 81.2% of these were clinically diagnosed and treated by the PHC doctors. The key facilitators of implementation were adequate training and supervision of field staff, ASHAs and doctors, use of electronic decision support, incorporation of a door-to-door c aign and use of culturally tailored dramas/videos to raise awareness about CMDs, and organising health c s at the village level facilitating delivery of intervention activities. Barriers to implementation included travel distance to receive care, limited knowledge about mental health, high level of stigma related to mental health issues, and poor mobile network signals and connectivity in the villages. Lack of familiarity with and access to mobile phones, especially among women, to accessing health related messages as part of the intervention. The evaluation not only provides a context to the interventions delivered, but also allowed an understanding of possible factors that need to be addressed to make the programme scalable and of benefit to policy makers.
Publisher: Frontiers Media SA
Date: 27-11-2020
Abstract: Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka. Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior–capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes. Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery. Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals.
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: Springer Science and Business Media LLC
Date: 02-03-2021
DOI: 10.1186/S13063-021-05136-5
Abstract: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. We hypothesise that an intervention involving an anti-stigma c aign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived—a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. The primary study outcome is the difference in mean behaviour scores at 12 months in the combined ‘high-risk’ and ‘non-high-risk’ cohort and the mean difference in PHQ-9 scores at 12 months in the ‘high-risk’ cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk in iduals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.
Publisher: Research Square Platform LLC
Date: 29-06-2023
DOI: 10.21203/RS.3.RS-2938523/V1
Abstract: Background Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally-enabled approach, “SMARThealth Pregnancy”, to improve health during pregnancy and the first year after birth. Methods A pragmatic, parallel-group, cluster-randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with: (1) medical officer and community health workers and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana, will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises: (i) an education programme for community health workers and PHC doctors (ii) the SMARThealth Pregnancy App for health workers to support community-based screening, referral, and follow-up of high-risk cases (iii) a dashboard for PHC doctors to monitor high-risk women in the community (iv) supply chain monitoring for consumables and medications, and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health, and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire). Discussion Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women’s lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world. Trial registration : clinicaltrials.gov NCT05752955. Date of registration 3 March 2023
Publisher: Wiley
Date: 25-10-2017
Abstract: Ferroelectricity is generally deteriorated or even vanishes when the ferroelectric films are downsized to unit cell scale. To maintain and enhance the polarization in nanoscale ferroelectrics are of scientific and technological importance. Here, giant polarization sustainability is reported in a series of ultrathin PbTiO
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: Public Library of Science (PLoS)
Date: 17-10-2006
Publisher: BMJ
Date: 08-2018
DOI: 10.1136/BMJOPEN-2018-022317
Abstract: Globally, the prevalence of uncontrolled hypertension is high, particularly in low- and middle-income countries. There is a critical need for strategies to improve hypertension control. The early use of a fixed low-dose combination of three antihypertensive drugs (triple pill) has the potential to significantly improve hypertension control. The TRI ple Pill vs. U sual care M anagement for P atients with mild-to- moderate H ypertension (TRIUMPH) randomised controlled trial (RCT) is designed to test the effects of this strategy compared with usual care in patients with mild-to-moderate hypertension. This paper reports the protocol of a process evaluation of the TRIUMPH RCT. The objectives are to understand factors related to implementation of the intervention, mechanisms of effect, contextual factors that underpin the effectiveness of the triple pill strategy and the potential barriers and facilitators to implementing the strategy in clinical practice. Face-to-face semistructured in-depth interviews with a purposive s le of TRIUMPH RCT participants and healthcare professionals in Sri Lanka will be conducted. Healthcare professionals will include physicians and their staff who were involved in conducting the TRIUMPH RCT. Interviewees will be recruited sequentially until thematic saturation is achieved. Interviews will be audio recorded, transcribed verbatim and analysed in NVivo using framework analysis methods. The TRIUMPH RCT and process evaluation have received approval from the relevant Ethics Review Committee. All participants will be asked to provide written consent before participation. Findings from the study will be disseminated through publications and conference presentations. ACTRN12612001120864 , SLCTR/2015/020 Pre-results.
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 Medical Association (AMA)
Date: 06-2022
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2009
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: Ubiquity Press, Ltd.
Date: 09-2019
Publisher: BMJ
Date: 27-10-2011
Publisher: Oxford University Press (OUP)
Date: 27-10-2012
DOI: 10.1111/J.2042-7174.2011.00175.X
Abstract: Cardiovascular disease is a major public health problem despite established treatment guidelines and significant healthcare expenditure worldwide. Poor medication compliance accounts in part for some of the observed evidence ractice gaps. Trials of fixed-dose combination pills are currently underway, but the attitudes of relevant health professionals to the routine use of a cardiovascular polypill are generally unknown. Pharmacists are a group of providers who play an important role in patient compliance with long-term medications. The objective was to identify the main perceived barriers to compliance and to investigate pharmacists' opinions regarding the routine use of a cardiovascular polypill. The setting was community pharmacies in the metropolitan and greater areas of New South Wales, Australia. Structured questionnaires were administered to a random s le of community pharmacists and peer-to-peer, semi-structured interviews were conducted with a sub-s le. Quantitative data were analysed using SPSS V16.0 and interviews were analysed thematically. Questionnaires were completed by 72 of the 250 pharmacists invited to participate. The major barrier to cardiovascular medication compliance identified by respondents was polypharmacy. Other barriers included patient disinterest, time constraints and costs. Most pharmacists agreed that a cardiovascular polypill could be one potential solution to poor compliance by simplifying the treatment regimen (73.6% agreed) and reducing patient costs (79.2% agreed). Inability to tailor treatment and to ascribe side effects was among some of the identified concerns. The use of a cardiovascular polypill as a means of increasing patient compliance with long-term cardiovascular preventive therapies is seen as potentially valuable by community pharmacists.
Publisher: Springer Science and Business Media LLC
Date: 26-05-2016
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: American Medical Association (AMA)
Date: 14-08-2018
Publisher: Wiley
Date: 27-08-2009
DOI: 10.1111/J.1753-0407.2009.00028.X
Abstract: To assess whether there is a statistical interaction between smoking and diabetes that is related to the risk of cardiovascular disease (CVD) in men in the Asia Pacific region. An in idual participant data meta-analysis was conducted on 34 cohort studies, involving 16 492 participants with diabetes (47.4% smokers) and 188 897 without (47.6% smokers). Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for smoking (stratified by study and adjusted for age) for those with and without diabetes. In men with diabetes, the HR (95% CI) comparing current smokers with non-smokers was 1.42 (1.10-1.83) for coronary heart disease, 1.10 (0.88-1.37) for total stroke and 1.15 (0.98-1.35) for total CVD. The corresponding figures for men without diabetes were 1.47 (1.33-1.61), 1.27 (1.16-1.39) and 1.35 (1.27-1.44), respectively. There was no evidence of a statistical interaction between diabetes and current smoking, the number of cigarettes smoked per day or quitting smoking. Smoking cessation was associated with a 19% reduction in CVD risk, irrespective of diabetes status. The effects of cigarette smoking and smoking cessation are broadly similar in men with and without diabetes. In Asia, where there are high rates of smoking and a rapidly increasing prevalence of diabetes, strategies that encourage smokers to quit are likely to have huge benefits in terms of reducing the burden of CVD in men with diabetes.
Publisher: AMPCo
Date: 02-09-2020
DOI: 10.5694/MJA2.50756
Publisher: Springer Science and Business Media LLC
Date: 23-09-2015
Publisher: Elsevier BV
Date: 2008
Publisher: Elsevier BV
Date: 12-2005
DOI: 10.1016/J.HLC.2005.06.010
Abstract: Investigation for cardiac source of embolus (CSE) is one of the commonest referrals for transthoracic echocardiography (TTE) of hospital inpatients, but has a relatively low-diagnostic yield. We sort to investigate whether 12-lead ECG might be useful in screening patients to obviate the need for TTE, in a subset of patients referred for echocardiographic investigation of cardiac source of embolus. We collected ECG and echo data for 400 consecutively referred inpatients for TTE investigation of possible cardiac source of embolus. We analysed this data for evidence of cardiac source of embolism on TTE in patients with a normal or abnormal ECG. 41/400 (10%) subjects had possible CSE identified on TTE. Diagnostic yield for CSE was higher for those with abnormal compared with normal ECG (17% versus 6%, p<0.001). Of 232/400 (58%) patients with a normal ECG, 200 had a normal TTE (86%). Of the 32 with normal ECG and abnormal TTE, echo found a possible embolic source in 13. Of those 168 (42%) with an abnormal ECG, TTE was normal in 73 and abnormal in 95, of whom 28 patients had an echo that identified a possible cardio-embolic source. ECG, therefore, had a sensitivity of 68%, specificity of 61%, positive predictive value of 0.17 and negative predictive value of 0.94 for detecting possible cardiac sources of embolus. Although TTE is a relatively low-yield investigation for the detection of cardiac source of embolus, 12-lead ECG is not sufficiently sensitive to identify the approximately 10% of patients in whom echo will demonstrate a diagnostic abnormality.
Publisher: Elsevier BV
Date: 11-2012
DOI: 10.1053/J.AJKD.2012.04.025
Abstract: Tools are needed to predict which in iduals with diabetes will develop kidney disease and its complications. An observational analysis of a randomized controlled trial. The ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) Study followed up 11,140 participants with type 2 diabetes for 5 years. Readily available baseline demographic and clinical variables. (1) Major kidney-related events (doubling of serum creatinine to ≥2.26 mg/dL [≥200 μmol/L], renal replacement therapy, or renal death) in all participants, and (2) new-onset albuminuria in participants with baseline normoalbuminuria. Cox proportional hazard regression models predicting the outcomes were used to generate risk scores. Discrimination of the risk prediction models was compared with that of models based on estimated glomerular filtration rate (eGFR) alone, urinary albumin-creatinine ratio (ACR) alone, and their combination. Risk scores for major kidney-related events and new-onset albuminuria were derived from 7- and 8-variable models, respectively. Baseline eGFR and ACR were dominant although models based on the 2 factors, alone or combined, had less discrimination (P<0.05) than the risk prediction models containing additional variables (risk prediction model C statistics of 0.847 [95% CI, 0.815-0.880] for major kidney-related events, and 0.647 [95% CI, 0.637-0.658] for new-onset albuminuria). Novel risk factors for new-onset albuminuria included Asian ethnicity and greater waist circumference, and for major kidney-related events, less education. The risk prediction models had acceptable calibration for both outcomes (modified Hosmer-Lemeshow test, P=0.9 and P=0.06, respectively). The follow-up period was limited to 5 years. Results are applicable to people with type 2 diabetes at risk of vascular disease. Risk scores have been developed for early and late events in diabetic nephropathy. Although eGFR and urinary ACR are important components of the prediction models, the extra variables considered add significantly to discrimination and, in the case of new-onset albuminuria, are required to achieve satisfactory calibration.
Publisher: Wiley
Date: 11-2010
DOI: 10.1111/J.1749-6632.2010.05837.X
Abstract: The world is facing an unprecedented increase in type 2 diabetes. Most disability and premature mortality experienced by people with diabetes is related to cardiovascular disease. This review summarizes recent evidence about approaches for managing cardiovascular risk in patients with type 2 diabetes. While optimal blood pressure targets in people with diabetes remain uncertain, new data have demonstrated the benefits of routine blood pressure lowering in these patients, when administered without regard to initial blood pressure level. Other recent data indicate that blood pressure lowering treatment in patients with diabetes needs to be continued for ongoing benefit. The effects of intensive blood glucose lowering have been evaluated recently in a number of large trials, and in idually these have failed to provide evidence of cardioprotection over a 4-5 year period. However, longer-term follow-up data suggest that there may be a delay in any such benefits becoming apparent. The benefits of statin therapy in preventing cardiovascular events in diabetic patients have been recently confirmed in a systematic overview of relevant trials however, effects of fibrate therapy appear more limited. The role of antiplatelet agents remains unknown, as adequately powered trials of aspirin for the primary prevention of cardiovascular events in patients with diabetes have not yet been completed.
Publisher: BMJ
Date: 03-2022
DOI: 10.1136/BMJOPEN-2021-054171
Abstract: Influenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease (CVD). Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year. However, there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomised controlled trials with larger s le sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates. We aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared with no vaccines or placebo for preventing mortality or CVD events in the general population and in populations with pre-existing CVD. Any types of randomised controlled trial and observational study meeting the Population, Intervention, Comparator, Outcome and Study design criteria for the research question will be selected for inclusion. The living systematic review status will be maintained for 3 years with an update for every 6 months. Mainstream medical literature databases will be independently searched by two authors with predefined strategies. Two authors will perform the risk of bias assessment with consensus. Narrative synthesis and meta-analyses will be performed to summarise the results. Formal ethical review is not required as this study does not involve primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings. CRD42021222519.
Publisher: Oxford University Press (OUP)
Date: 14-10-2007
Abstract: The inverse relationship between high-density lipoprotein (HDL) cholesterol and coronary heart disease (CHD) is well established. Questions remain about the association between HDL cholesterol and stroke, particularly for stroke subtypes. Cox survival models were applied to in idual participant data from 25 cohort studies (about 80 000 subjects), with a median of 6.8 years follow-up. After adjustment for age and regression dilution, hazard ratios (95% confidence intervals) for a 1 standard deviation (SD) lower level of HDL cholesterol (0.4 mmol/L) were: for CHD events, 1.39 (1.22-1.57) for ischaemic stroke, 0.90 (0.75-1.07), and for haemorrhagic stroke, 0.89 (0.74-1.07). As total cholesterol (TC) increased relative to HDL cholesterol, the risk of CHD increased, the risk of ischaemic stroke was unchanged but the risk of haemorrhagic stroke decreased. A 1 SD increase in TC/HDL cholesterol (1.63 units) was associated with a 27% decrease in the risk of haemorrhagic stroke (95% confidence interval, 7-44%). There is clear evidence of potential benefit for CHD of increases in HDL cholesterol and decreases in TC relative to HDL cholesterol, but no evidence of an association between either HDL cholesterol or TC/HDL cholesterol and ischaemic stroke. Increasing HDL cholesterol relative to TC may increase the risk of haemorrhagic stroke.
Publisher: American Medical Association (AMA)
Date: 24-02-2010
Publisher: American Medical Association (AMA)
Date: 02-03-2022
Publisher: Wiley
Date: 09-2018
DOI: 10.1002/CLC.23040
Publisher: BMJ
Date: 06-2022
DOI: 10.1136/BMJOPEN-2021-058669
Abstract: In India about 95% of in iduals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction c aign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)—to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk in iduals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health. The process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory. The study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms. CTRI/2018/08/015355.
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: Ovid Technologies (Wolters Kluwer Health)
Date: 07-02-2017
DOI: 10.1161/CIRCULATIONAHA.116.027038
Abstract: Anushka Patel is the Chief Scientist, The George Institute for Global Health, Professor of Medicine, University of Sydney and a Cardiologist, at Royal Prince Alfred Hospital, all based in Sydney, Australia. She obtained her MBBS from the University of Queensland, a Master of Science degree in Epidemiology from Harvard University, and her PhD from the University of Sydney.
Publisher: CSIRO Publishing
Date: 2017
DOI: 10.1071/PY16166
Abstract: The aim of this study is to investigate the utilisation of Medicare Benefit Scheme items for chronic disease in the management of cardiovascular disease (CVD) in general practice and to compare characteristics of CVD patients with and without a General Practice Management Plan (GPMP). Subgroup analysis of Treatment of Cardiovascular Risk using Electronic Decision Support (TORPEDO) baseline data was collected in a cohort comprising 6123 patients with CVD. The mean age (s.d.) was 71 (±13) years, 55% were male, 64% had a recorded diagnosis of coronary heart disease, 31% also had a diagnosis of diabetes and the mean number of general practice (GP) visits (s.d.) was 11 (±9) in 12 months. A total of 1955/6123 (32%) received a GPMP in the 12 months before data extraction 1% received a Mental Health Plan. Factors associated with greater likelihood of receiving a GPMP were: younger age, had a diagnosis of diabetes, BMI 30kgm–2, prescription of blood pressure-lowering therapy and more than ten general practice visits. Enhancing utilisation of existing schemes could augment systematic follow up and support of patients with CVD.
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: 12-11-2009
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2006
Publisher: American Diabetes Association
Date: 13-10-2012
DOI: 10.2337/DC12-0306
Abstract: Although low HDL cholesterol (HDL-C) is an established risk factor for atherosclerosis, data on HDL-C and the risk of microvascular disease are limited. We tested the association between HDL-C and microvascular disease in a cohort of patients with type 2 diabetes. A total of 11,140 patients with type 2 diabetes and at least one additional vascular risk factor were followed a median of 5 years. Cox proportional hazards models were used to assess the association between baseline HDL-C and the development of new or worsening microvascular disease, defined prospectively as a composite of renal and retinal events. The mean baseline HDL-C level was 1.3 mmol/L (SD 0.45 mmol/L [range 0.1–4.0]). During follow-up, 32% of patients developed new or worsening microvascular disease, with 28% experiencing a renal event and 6% a retinal event. Compared with patients in the highest third, those in the lowest third had a 17% higher risk of microvascular disease (adjusted hazard ratio 1.17 [95% CI 1.06–1.28], P = 0.001) after adjustment for potential confounders and regression dilution. This was driven by a 19% higher risk of renal events (1.19 [1.08–1.32], P = 0.0005). There was no association between thirds of HDL-C and retinal events (1.01 [0.82–1.25], P = 0.9). In patients with type 2 diabetes, HDL-C level is an independent risk factor for the development of microvascular disease affecting the kidney but not the retina.
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: Wiley
Date: 16-06-2005
Publisher: International Global Health Society
Date: 18-03-2017
Publisher: Elsevier BV
Date: 08-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2009
Publisher: Informa UK Limited
Date: 2008
DOI: 10.4161/AUTO.5127
Abstract: Weak organic acids are an important class of food preservatives that are particularly efficacious towards yeast and fungal spoilage. While acids with small aliphatic chains appear to function by acidification of the cytosol and are required at high concentrations to inhibit growth, more hydrophobic organic acids such as sorbic and benzoic acid have been suggested to function by perturbing membrane dynamics and are growth-inhibitory at much lower concentrations. We previously demonstrated that benzoic acid has selective effects on membrane trafficking in Saccharomyces cerevisiae. Benzoic acid selectively blocks macroautophagy in S. cerevisiae while acetic acid does not, and sorbic acid does so to a lesser extent. Indeed, while both benzoic acid and nitrogen starvation are cytostatic when assayed separately, the combination of these treatments is cytocidal, because macroautophagy is essential for survival during nitrogen starvation. In this report, we demonstrate that Zygosaccharomyces bailii, a food spoilage yeast with relatively high resistance to weak acid stress, also exhibits a cytocidal response to the combination of benzoic acid and nitrogen starvation. In addition, we show that nitrogen starvation can be replaced by caffeine supplementation. Caffeine induces a starvation response that includes the induction of macroautophagy, and the combination of caffeine and benzoic acid is cytocidal, as predicted from the nitrogen starvation data.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 26-09-2012
Abstract: A higher resting heart rate is associated with an increased probability of cardiovascular complications and premature death in patients with type 2 diabetes mellitus. The impact of heart rate on the risk of developing microvascular complications, such as diabetic retinopathy and nephropathy, is, however, unknown. The present study tests the hypothesis that a higher resting heart rate is associated with an increased incidence and a greater progression of microvascular complications in patients with type 2 diabetes mellitus. The relation between baseline resting heart rate and the development of a major microvascular event was examined in 11 140 patients who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study. Major microvascular events were defined as a composite of new or worsening nephropathy or new or worsening retinopathy. Patients with a higher baseline heart rate were at increased risk of a new major microvascular complication during follow‐up (adjusted hazard ratio: 1.13 per 10 beats per minute 95% confidence interval: 1.07–1.20 P .001). The excess hazard was evident for both nephropathy (adjusted hazard ratio: 1.16 per 10 beats per minute 95% confidence interval: 1.08–1.25) and retinopathy (adjusted hazard ratio: 1.11 per 10 beats per minute 95% confidence interval: 1.02–1.21). Patients with type 2 diabetes mellitus who have a higher resting heart rate experience a greater incidence of new‐onset or progressive nephropathy and retinopathy. URL: www.clinicaltrials.gov . Unique identifier: NCT00145925. tatic/html rehome rehome.asp
Publisher: Elsevier BV
Date: 10-2019
Publisher: Elsevier BV
Date: 11-2010
Publisher: AMPCo
Date: 26-04-2021
DOI: 10.5694/MJA2.51030
Publisher: Public Library of Science (PLoS)
Date: 12-10-2016
Publisher: Elsevier BV
Date: 10-2017
DOI: 10.1016/J.AMJCARD.2017.06.044
Abstract: Currently available risk scores (RSs) were derived from populations with very few participants from China. We aimed to develop an RS based on data from patients with acute coronary syndrome in China and to compare its performance with the commonly promoted Global Registry of Acute Coronary Events (GRACE) RS. Clinical Pathways for Acute Coronary Syndromes-Phase 2 was a trial of a quality improvement intervention in China. Patients recruited from 75 hospitals from October 2007 to August 2010 were ided into training and validation sets based on immediate or delayed implementation. A Clinical Pathways for Acute Coronary Syndromes (CPACS) RS for in-hospital mortality was developed separately by gender, using the training set (6,790 patients). Discrimination and calibration of the CPACS RS and GRACE RS were compared on the validation set (3,801 patients). Although discrimination of the GRACE RS was acceptable, this was improved with the CPACS RS (c-statistic 0.82 vs 0.87, p = 0.012 for men c-statistic 0.78 vs 0.85, p = 0.006 for women). The absolute bias was significantly lower with CPACS RS for both genders (7.6% vs 97.5% in men and 21.5% vs 77.2% in women), compared with the GRACE RS, which systematically overestimated risk. The CPACS RS underestimated risk in women, but only in those already above threshold levels currently used to define a clinical high-risk population. In conclusion, the GRACE RS substantially overestimates the risk of in-hospital death in patients presenting to the hospital with a suspected acute coronary syndrome in China. We have developed and independently validated a new RS utilizing data from Chinese patients.
Publisher: CSIRO Publishing
Date: 2017
DOI: 10.1071/AH15230
Abstract: Recent trends in health research funding towards ‘safe bets’ is discouraging investment into the development of health systems interventions and choking off a vital area of policy-relevant research. This paper argues that to encourage investment into innovative and perceivably riskier health systems research, researchers need to create more attractive business cases by exploring alternative approaches to the design and evaluation of health system interventions. At the same time, the creation of dedicated funding opportunities to support this work, as well as for relevant early career researchers, is needed.
Publisher: Massachusetts Medical Society
Date: 09-10-2014
Publisher: Cold Spring Harbor Laboratory
Date: 11-2021
DOI: 10.1101/2021.10.31.21265595
Abstract: Gestational diabetes mellitus (GDM), once considered a transient condition during pregnancy, is now a firmly established risk factor for type 2 diabetes mellitus (T2DM). Women whose blood glucose levels do not return to normal soon after giving birth are particularly at high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions are recommended for women with GDM to prevent or delay the subsequent development of T2DM. Recent systematic reviews and meta-analyses have suggested postpartum lifestyle interventions may be beneficial in reducing the risk of developing diabetes in women with GDM, however, included studies were generally small, many had a high risk of bias and subsequent data have become available with new trials likely to complete in the next couple of years. In addition, to the best of our knowledge, formal systematic review and meta-analysis of other approaches to preventing diabetes in this population (e.g. pharmacotherapy) has not been attempted. Therefore, an updated systematic review is needed and will be formulated as a living systematic review to ensure the inclusion of emerging studies. A living systematic review and a prospective meta-analysis to examine the effectiveness of postpartum interventions in reducing the risk of developing T2DM in women with recent GDM. Ethics committee approval is not required. The data included will be from published studies, and a continued living systematic review and prospective meta-analysis will occur once a year for the next five years. Results of the review will be disseminated at relevant meetings. CRD42021279891 A living systematic review will allow continuous surveillance of emerging literature on different lifestyle interventions in women with a history of GDM and allow identification of effective strategies for diabetes prevention. We estimate considerable heterogeneity of interventions which may limit our ability to make clear conclusions.
Publisher: Center for Open Science
Date: 25-03-2021
Abstract: The LIVING trial aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. This statistical analysis plan provides the details of all the pre-specified analyses including the analysis of all primary and secondary endpoints. This detailed statistical analysis plan (SAP) was written by the statisticians and chief investigators prior to unblinding and database lock.
Publisher: Massachusetts Medical Society
Date: 07-10-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2007
Publisher: Public Library of Science (PLoS)
Date: 29-03-2016
Publisher: Public Library of Science (PLoS)
Date: 16-06-2023
DOI: 10.1371/JOURNAL.PGPH.0001947
Abstract: Uncertainties about the efficacy of influenza vaccination for populations with heart failure (HF) in preventing cardiovascular outcomes, as well as lack of effective vaccination strategies, may contribute to low vaccine coverage rate (VCR) in China and globally. We assessed the feasibility of a strategy to promote influenza vaccines in patients hospitalized with acute HF in China and to inform the design of a hybrid effectiveness-implementation cluster randomized trial to evaluate this strategy on mortality and hospital re-admission. We conducted a cluster randomized pilot trial involving 11 hospitals in Henan Province in China, with mixed-methods evaluation between December 2020 and April 2021. A process evaluation involved interviews with 51 key informants (patients, health professionals, policy makers). The intervention included education about influenza vaccination and availability of free vaccines administered prior to hospital discharge for HF patients, while usual care included attending community-based points of vaccination (PoV) for screening and vaccination. Implementation outcomes focused on reach, fidelity, adoption, and acceptability. Recruitment rates were assessed for trial feasibility. Effectiveness outcomes were influenza VCR, HF-specific rehospitalizations and mortality at 90 days. A total of 518 HF patients were recruited from 7 intervention and 4 usual care hospitals (mean of 45 participants per hospital per month). VCR was 89.9% (311/346, 86.1–92.8%) in the intervention group and 0.6% (1/172, 0.0–3.7%) in the control group. The process evaluation demonstrated reach to patients with lower socioeconomic and education status. There was good fidelity of the intervention components, with education and PoV set up processes being adapted to local hospital workflow and workforce capacity. Intervention was acceptable and adopted by patients and health professionals. However, outside of a trial setting, concerns were raised around vaccination reimbursement costs, workforce accountability and capacity. The intervention strategy appears feasible and acceptable for improving VCR in HF patients at county-level hospitals in China. Trial registration: This pilot trial is registered with the acronym PANDA II Pilot (Population Assessment of Influenza and Disease Activity) at ChiCTR.org.cn ( ChiCTR2000039081 ).
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2007
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: 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: Elsevier BV
Date: 08-2018
DOI: 10.1016/J.AHJ.2018.05.004
Abstract: Depression and acute coronary syndromes (ACS) are both common public health challenges. Patients with ACS often develop depression, which in turn adversely affects prognosis. Low-cost, sustainable, and effective service models that integrate depression care into the management of ACS patients to reduce depression and improve ACS outcomes are critically needed. Integrating Depression Care in ACS patients in Low Resource Hospitals in China (I-CARE) is a multicenter, randomized controlled trial to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in management of ACS patients. Four thousand inpatients will be recruited and then randomized in a 1:1 ratio to an IC intervention consisting of nurse-led risk factor management, group-based counseling supplemented by in idual problem-solving therapy, and antidepressant medications as needed, or to UC. The primary outcomes are depression symptoms measured by the Patient Health Questionnaire-9 at 6 and 12 months. Secondary endpoints include anxiety measured by the Generalized Anxiety Disorder-7 quality of life measured by the EQ-5D at 6 and 12 months and major adverse events including the combined end point of all-cause death, suicide attempts, nonfatal myocardial infarction, nonfatal stroke, and all-cause rehospitalization at yearly intervals for a median follow-up of 2 years. Analyses of the cost-effectiveness and cost-utility of IC also will be performed. I-CARE trial will be the largest study to test the effectiveness of an integrated care model on depression and cardiovascular outcomes among ACS patients in resource-limited clinical settings.
Publisher: Oxford University Press (OUP)
Date: 04-2002
Publisher: Public Library of Science (PLoS)
Date: 19-12-2012
Publisher: Elsevier BV
Date: 03-2013
DOI: 10.1038/KI.2012.401
Abstract: The effect of intensive glucose control on major kidney outcomes in type 2 diabetes remains unclear. To study this, the ADVANCE trial randomly assigned 11,140 participants to an intensive glucose-lowering strategy (hemoglobin A1c target 6.5% or less) or standard glucose control. Treatment effects on end-stage renal disease ((ESRD), requirement for dialysis or renal transplantation), total kidney events, renal death, doubling of creatinine to above 200 μmol/l, new-onset macroalbuminuria or microalbuminuria, and progression or regression of albuminuria, were then assessed. After a median of 5 years, the mean hemoglobin A1c level was 6.5% in the intensive group, and 7.3% in the standard group. Intensive glucose control significantly reduced the risk of ESRD by 65% (20 compared to 7 events), microalbuminuria by 9% (1298 compared to 1410 patients), and macroalbuminuria by 30% (162 compared to 231 patients). The progression of albuminuria was significantly reduced by 10% and its regression significantly increased by 15%. The results were almost identical in analyses taking account of potential competing risks. The number of participants needed to treat over 5 years to prevent one ESRD event ranged from 410 in the overall study to 41 participants with macroalbuminuria at baseline. Thus, improved glucose control will improve major kidney outcomes in patients with type 2 diabetes.
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: AMPCo
Date: 10-2002
Publisher: Public Library of Science (PLoS)
Date: 23-02-2010
Publisher: AMPCo
Date: 09-2009
DOI: 10.5694/J.1326-5377.2009.TB02816.X
Abstract: To evaluate the management of cardiovascular disease (CVD) risk in Australian general practice. National cross-sectional survey of 99 Australian general practitioners participating in the Bettering the Evaluation and Care of Health (BEACH) program. Data on 2618 consecutive adult patients presenting to the participating GPs over a 5-week period from September to October 2006 were analysed. Proportions of patients screened, treated and reaching targets according to (1) current Australian CVD risk guidelines and (2) overall or absolute CVD risk. Blood pressure (BP) had not been recorded for 13% of the s le. Of 1400 patients not prescribed antihypertensive medication, treatment was indicated for 8%. Of 821 patients already prescribed antihypertensive medication, 59% were achieving target BPs. Data on low-density lipoprotein (LDL) cholesterol levels were not available for 53% of the 2175 patients who should have had lipid screening according to the guidelines. Of 624 patients not prescribed a statin, treatment was indicated for 41%. Of 368 already prescribed a statin, 62% were achieving target LDL cholesterol levels. Sufficient data for calculation of absolute risk had been recorded for 74% of the 1736 patients for whom such calculation was recommended by the guidelines. The remaining 26% either had at least one required variable unmeasured (20%) or missing from the data collection (6%). For those at high absolute CVD risk (without established disease) and those with established CVD, 23% and 53%, respectively, had been prescribed both antihypertensive medication and a statin. Gaps between guideline recommendations and practice in recording and managing BP were relatively low compared with gaps for lipids. When stratified by absolute risk, patients at high risk of a cardiovascular event were found to be substantially undertreated.
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: 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: Springer Science and Business Media LLC
Date: 03-2018
Publisher: Oxford University Press (OUP)
Date: 02-2006
DOI: 10.1097/00149831-200602000-00005
Abstract: Coronary risk prediction 'engines' are now in common use, and their worth is well proven. There remains the question of how to deal with a prior diagnosis of diabetes. An in idual participant meta-analysis of 33 cohort studies involving 364 566 subjects. Fatal coronary hazard ratios for age, smoking, systolic blood pressure and cholesterol, were computed from Cox models, comparing those with and without diabetes. Three risk prediction equations were compared: a 'stepped model', which included the risk factors and diabetes status an 'interaction model', which included interactions between diabetes and the risk factors and a 'fixed model', which fixed the 10-year rate of coronary death amongst those with diabetes to be 7%. These were compared through the area under the receiver operating characteristic curve (AUC) and Hosmer-Lemeshow statistics. The hazard ratio for age was greater for those without diabetes than those with, for men (P=0.005) and women (P=0.02) for men only, systolic blood pressure showed a similar differential (P=0.011). Nevertheless, AUCs were only 0.001 different for the stepped and interaction models for each sex. The AUC for the fixed model was lower and, unlike the other two, showed significant lack of fit for both sexes (P<0.001). There is no justification for developing separate risk prediction models for those with and without diabetes, nor for assuming that everyone with diabetes should be considered as being at a common high level of risk. Diabetes status might, instead, be used as a risk variable in an overall population equation.
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: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2022
DOI: 10.2215/CJN.00180122
Abstract: Hyperkalemia after starting renin-angiotensin system inhibitors has been shown to be subsequently associated with a higher risk of cardiovascular and kidney outcomes. However, whether to continue or discontinue the drug after hyperkalemia remains unclear. Data came from the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, which included a run-in period where all participants initiated angiotensin-converting enzyme inhibitor–based therapy (a fixed combination of perindopril and indapamide). The study population was taken as patients with type 2 diabetes with normokalemia (serum potassium of 3.5 to .0 mEq/L) at the start of run-in. Potassium was remeasured 3 weeks later when a total of 9694 participants were classified into hyperkalemia (≥5.0 mEq/L), normokalemia, and hypokalemia ( .5 mEq/L) groups. After run-in, patients were randomized to continuation of the angiotensin-converting enzyme inhibitor–based therapy or placebo major macrovascular, microvascular, and mortality outcomes were analyzed using Cox regression during the following 4.4 years (median). During active run-in, 556 (6%) participants experienced hyperkalemia. During follow-up, 1505 participants experienced the primary composite outcome of major macrovascular and microvascular events. Randomized treatment of angiotensin-converting enzyme inhibitor–based therapy significantly decreased the risk of the primary outcome (38.1 versus 42.0 per 1000 person-years hazard ratio, 0.91 95% confidence interval, 0.83 to 1.00 P =0.04) compared with placebo. The magnitude of effects did not differ across subgroups defined by short-term changes in serum potassium during run-in ( P for heterogeneity =0.66). Similar consistent treatment effects were also observed for all-cause death, cardiovascular death, major coronary events, major cerebrovascular events, and new or worsening nephropathy ( P for heterogeneity ≥0.27). Continuation of angiotensin-converting enzyme inhibitor–based therapy consistently decreased the subsequent risk of clinical outcomes, including cardiovascular and kidney outcomes and death, regardless of short-term changes in serum potassium. Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), NCT00145925
Publisher: AMPCo
Date: 07-2015
DOI: 10.5694/MJA14.00581
Abstract: To identify facilitators and barriers to clinical trial implementation in Aboriginal health services. Indepth interview study with thematic analysis. Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill (KGAP) study, a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease. 32 health care providers and 21 Aboriginal and Torres Strait Islander patients. A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service. That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients. Enlisting the support of Aboriginal and Torres Strait Islander staff ch ions who were visible to the community as the main source of information about the trial was particularly important. The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures. This was partially alleviated by the research team's provision of onsite support and attempts to make trial processes more streamlined. Although more intensive support was highly desired, there were usually insufficient resources to provide this. Despite strong community and health service support, major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched, routine services. Trial budgets will necessarily be inflated as a result. Funding agencies need to consider these additional resource demands when supporting trials of a similar nature.
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: Elsevier BV
Date: 03-2004
DOI: 10.1016/J.HLC.2004.01.007
Abstract: Early definition of treatment outcomes, including coronary patency and infarct size, after reperfusion therapy for myocardial infarction (MI) is desirable to identify patients requiring further intervention. Patients receiving reperfusion therapy for a first MI had continuous 12-lead ST segment monitoring to document reperfusion and ischaemia time. Infarct size was measured by 12-lead QRS score and radionuclide scintigraphy ((201)Tl single-photon emission computed tomography, SPECT) at 1 week, and left ventricular function by echocardiography at 1 week and 1 month. Resolution of ST elevation accurately detected TIMI 2 or 3 reperfusion (predictive accuracy 93%) in 55 patients undergoing immediate angioplasty, but ST recovery was delayed (17+/-14min) after angiographic reperfusion. A multivariate model, including risk region and ischaemia time, accurately predicted MI size (R(2)=0.80, P<0.00001) in these patients. The same model, prospectively applied on Day 1 to 154 patients receiving thrombolytic therapy, accurately predicted MI size, measured by QRS score (R(2)=0.88, P<0.0000001) and (201)Tl SPECT (R(2)=0.75, P<0.000001) at 1 week for in idual patients. Regional myocardial wall motion at 1 month was directly correlated with MI size predicted by the model on Day 1 (r=0.73, P<0.0001). Use of ST segment monitoring during reperfusion therapy facilitates early prediction of treatment outcomes, including coronary reperfusion, infarct size and ventricular function.
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: Bentham Science Publishers Ltd.
Date: 31-12-2013
DOI: 10.2174/15748863113086660070
Abstract: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges, which need to be addressed when re-analysing trial data for cancer related outcomes. Substantial amount of information on cancer outcomes is available from RCTs. Hence, making use of such data could save time and spare patients from inclusion in further trials. However, methodological challenges must be addressed to enhance the likelihood of reliable conclusions. Advantages of post-hoc analyses of RCTs include quality of data collected and sometimes randomisation to exposure of interest. Limitations include confounding and s le size, which is fixed to suit the purposes of the trial, insufficient duration of exposure and identification of underlying biological mechanisms relating treatment to cancer to formulate the most appropriate post-hoc study design.
Publisher: Wiley
Date: 09-07-2014
DOI: 10.1002/YEA.3025
Abstract: Metabolic engineering of microbial strains to produce aromatic compounds deriving from the shikimate pathway is of great interest to the chemical industry as a more sustainable alternative for feedstock production. Chorismate is a significant intermediate in the shikimate pathway. In this study, the formation of phenylalanine and phenylpyruvate as by-products in strains engineered downstream of the chorismate node for increased aromatic production was explored in yeast fermentations. Tracer experiments showed that these compounds are synthesized de novo during fermentation, under conditions in which their synthesis was genetically blocked. Chorismate stability evaluation, as well as deletion mutation analysis throughout the phenylalanine biosynthesis pathway, suggested that this synthesis was a result of intracellular, non-enzymatic rearrangement of chorismate to phenylpyruvate via prephenate, which was followed by enzymatic transamination of phenylpyruvate to form phenylalanine. These results not only aid in the development of strain-engineering strategies to avoid the accumulation of by-products during fermentations aimed at increased aromatics production, but also deepen our understanding of yeast metabolism.
Publisher: SAGE Publications
Date: 13-02-2015
Abstract: Background: Polypill-based strategies have improved patient use of preventive cardiovascular disease (CVD) medications in clinical trials. Continued use in real-world settings relies on patients preferring a polypill over current treatment. Objective: Within a clinical trial assessing a CVD polypill-based strategy on patient adherence (Kanyini Guidelines Adherence with the Polypill study [Kanyini GAP]), we used discrete choice experiment (DCE) to assess the influence of polypill-based treatment attributes and patient characteristics on preferences for CVD preventive treatment. Methods: A DCE survey was administered to Kanyini GAP participants, involving choices between 2 hypothetical treatment options and no treatment for CVD prevention. Attributes delineating a polypill from current treatment were assessed: out-of-pocket costs, tablet number, administration, and prescriber visit frequency. The odds ratios (ORs) for preferring treatment, trade-off between treatment-related attributes, and willingness to pay against other attributes were estimated. Results: In all, 332 of 487 (68%) participants completed the survey. Active treatment, compared with no treatment, was chosen by 93%. Treatment preference decreased with increasing out-of-pocket cost (OR = 0.04 95% CI = 0.03-0.05) and tablet number (OR = 0.69 95% CI = 0.59-0.81). Out-of-pocket cost was the most important attribute. Respondents were willing to pay $3.45 per month for each tablet reduction. Education and household income significantly influenced treatment preference. Conclusions: Assuming equivalent efficacy and safety of treatment options, the treatment-specific attributes that were assessed and influenced patient preference strongly accord with the posited advantages of the cardiovascular polypill. The study provides promising evidence that improvements in treatment adherence observed in CVD polypill trials may translate to the real world and potentially close treatment gaps in CVD prevention.
Publisher: Springer Science and Business Media LLC
Date: 25-07-2009
DOI: 10.1007/S00125-009-1457-X
Abstract: The aim of the present study was to investigate the effect of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in type 2 diabetic patients. The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) Retinal Measurements study, a substudy of ADVANCE, is a randomised (using a central, computer-based procedure) controlled 2 x 2 factorial trial comprising a double-blind comparison of blood pressure lowering with perindopril-indapamide vs placebo, and an open comparison of standard vs intensive glucose control targeting a HbA(1c) of or =2 steps in the Early Treatment of Diabetic Retinopathy Study classification (using the eye with worst grading) was the primary outcome. Retinopathy progressed in 59 (4.8%) patients and developed in 128 (10.3%) patients over 4.1 years. Fewer patients on blood pressure-lowering treatment (n = 623) experienced incidence or progression of retinopathy compared with patients on placebo (n = 618), but the difference was not significant (OR 0.78 95% CI 0.57-1.06 p = 0.12). Blood pressure-lowering treatment reduced the occurrence of macular oedema (OR 0.50 95% CI 0.29-0.88 p = 0.016) and arteriovenous nicking compared with placebo (OR 0.60 95% CI 0.38-0.94 p = 0.025). Compared with standard glucose control (n = 611), intensive glucose control (n = 630) did not reduce (p = 0.27) the incidence and progression of retinopathy (OR 0.84 95% CI 0.61-1.15). Lower, borderline significant risks of microaneurysms, hard exudates and macular oedema were observed with intensive glucose control, adjusted for baseline retinal haemorrhages. These effects of the two treatments were independent and additive. Adverse events in the ADVANCE study are reported elsewhere. Blood pressure lowering or intensive glucose control did not significantly reduce the incidence and progression of retinopathy, although consistent trends towards a benefit were observed, with significant reductions in some lesions observed with both interventions. ClinicalTrials.gov ID no. NCT00145925. Grants from Servier and the National Health and Medical Research Council of Australia.
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: Springer Science and Business Media LLC
Date: 12-2015
Publisher: Elsevier BV
Date: 03-2017
Publisher: Wiley
Date: 27-02-2008
DOI: 10.1111/J.1440-1681.2008.04892.X
Abstract: 1. The epidemic of diabetes is accelerating and the World Health Organization estimates that the number of people affected worldwide will grow from 171 million in 2000 to 366 million by 2030. 2. The main causes of death and disability in in iduals with type 2 diabetes are macrovascular and microvascular disease, and blood pressure is one of the main determinants of vascular complications in this population. 3. While randomized trials have demonstrated that blood pressure lowering reduces vascular complications in subjects with type 2 diabetes and hypertension, ADVANCE was designed to determine whether the addition of a fixed combination of perindopril and indapamide, on top of comprehensive and effective cardiovascular treatments and glucose control therapy, would produce further benefits, irrespective of the initial blood pressure. 4. The blood pressure lowering arm of ADVANCE has demonstrated that the simple addition of the fixed combination of perindopril and indapamide compared to matching placebo, significantly reduces combined macrovascular and microvascular complications by 9%, all-cause mortality by 14% and cardiovascular death by 18%. It also reduces total coronary events by 14% and all renal events and microalbuminuria by 21%. 5. Similar benefits were observed in participant sub-groups characterized by age, sex, baseline blood pressure, previous vascular diseases and concomitant cardiovascular therapy including blood pressure lowering therapy. 6. Successful implementation of this treatment, with a single combination tablet of perindopril and indapamide, should be practical and affordable in most clinical settings worldwide and has the capacity to save countless lives and to reduce the burden of coronary disease and renal disease burden among millions of people with type 2 diabetes.
Publisher: Wiley
Date: 2013
Abstract: In our modern 'omics era, metabolic flux analysis (fluxomics) represents the physiological counterpart of its siblings transcriptomics, proteomics and metabolomics. Fluxomics integrates in vivo measurements of metabolic fluxes with stoichiometric network models to allow the determination of absolute flux through large networks of the central carbon metabolism. There are many approaches to implement fluxomics including flux balance analysis (FBA), (13) C fluxomics and (13) C-constrained FBA as well as many experimental settings for flux measurement including dynamic, stationary and semi-stationary. Here we outline the principles of the different approaches and their relative advantages. We demonstrate the unique contribution of flux analysis for phenotype elucidation using a thoroughly studied metabolic reaction as a case study, the microbial aerobic/anaerobic shift, highlighting the importance of flux analysis as a single layer of data as well as interlaced in multi-omics studies.
Publisher: Public Library of Science (PLoS)
Date: 12-08-2014
Publisher: American Chemical Society (ACS)
Date: 05-04-2021
Publisher: Hindawi Limited
Date: 2016
DOI: 10.1017/GHEG.2016.10
Abstract: Non-communicable diseases (NCDs) have reached pandemic levels globally and pose a major threat to social and economic development worldwide. The discipline of epidemiology has done much to bring this issue to the forefront of global health. Epidemiological approaches have broadened our understanding of the impact of NCDs in widening socioeconomic disparities. Over a number of decades, this discipline has also contributed to the development of many preventive measures and treatments of known efficacy and safety. However, epidemiology also has a critical role to play in better translating these discoveries into practice, through the new science of implementation. As we strive to achieve the “25 by 25” goal of a 25% reduction in premature mortality from common NCDs by 2025, the discipline of epidemiology will need to continuously evolve to remain an essential tool for public health action.
Publisher: Elsevier BV
Date: 03-2008
DOI: 10.1016/J.AHJ.2008.09.026
Abstract: Coronary heart disease has emerged as a leading cause of death in China. Although there is strong evidence for the use of antiplatelet, blood pressure-lowering, and lipid-lowering therapy in patients with acute coronary syndromes, the extent to which these medications are used in China remains uncertain. We conducted a multicenter prospective study using data from consecutive patients diagnosed with suspected acute myocardial infarction or unstable angina pectoris admitted to the inpatient wards during the recruitment period. Medication adherence and reasons for nonadherence were reported using standardized questionnaires. Logistic regression was used to identify important patient and hospital characteristics associated with use of medication at 6 and 12 months after hospital discharge. The use of drug therapy was high (above 90% for aspirin, 70% for beta-blockers and angiotensin-converting enzyme inhibitors, 80% for statin) at the time of hospital discharge but decreased during follow-up. However, fewer than half (48%) of patients were discharged on 4-drug combination therapy (antiplatelet, beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and statin), and the proportion remaining on this treatment 1 year after discharge was even lower (41%). In adjusted logistic regression analyses, medical insurance, dyslipidemia, hypertension, and administration of invasive therapy (percutaneous coronary intervention or coronary artery bypass graft) were important in determining use of treatment at discharge and during follow-up. In a substantial proportion of patients, medication was considered "not indicated" by the treating physician. The findings highlight opportunities to improve the use and maintenance of appropriate combinations of evidence-based treatment among patients with acute coronary syndromes presenting to hospitals in China.
Publisher: Massachusetts Medical Society
Date: 20-07-2017
DOI: 10.1056/NEJMC1703337
Publisher: BMJ
Date: 2012
Publisher: Public Library of Science (PLoS)
Date: 19-01-2021
DOI: 10.1371/JOURNAL.PONE.0245576
Abstract: In low-resource regions, fibrinolytic therapy is often the only option for ST-elevation myocardial infarction (STEMI) patients as primary percutaneous coronary intervention (PCI) is often not available and patients are hardly transferred to a medical center with PCI capacity within the first 120 minutes. Chronic kidney disease (CKD) is one of the most frequently encountered complications of STEMI. However, the evidence for the efficacy of fibrinolytic therapy in STEMI patients with CKD is still limited. The aim of this study is to test whether CKD modifies the association between fibrinolytic therapy and short-term major adverse cardiovascular events (MACEs) among patients with STEMI. This is a real-world study analyzing the data from 9508 STEMI patients (mean age: 64.0±12.4 years male: 70.1%) in the third phase of Clinical Pathways in Acute Coronary Syndromes program (CPACS-3), which is a large study of the management of acute coronary syndromes (ACS) in 101 county hospitals without PCI capacity in China. CKD was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1·73 m 2 at the admission. The primary outcome is short-term MACEs, including all-cause death, recurrent myocardial infarction, or nonfatal stroke. Patients were recruited consecutively between October 2011 and November 2014. Out of them, 1282 patients (13.5%) were classified as having CKD. Compared with non-CKD patients, CKD patients were less likely to receive fibrinolytic therapy than non-CKD patients (26.4% vs. 38.9%, P .001), more likely to experience a failed fibrinolytic therapy (32.8% vs. 16.9%), and had a higher risk of short-term MACEs (19.7% vs. 5.6%). After full adjustment, use of fibrinolytic therapy was associated with a significantly lower risk of short-term MACEs in non-CKD patients (relative risk [RR] = 0.87, 95% confidence interval [CI]: 0.76–0.99), but not in CKD patients ( P for interaction = 0.026). Further analysis stratified by the success of fibrinolysis showed that compared with patients who did not receive fibrinolytic therapy, patients with successful fibrinolysis had a lower risk of short-term MACEs that was similar between patients with (RR = 0.71, 95% CI: 0.55–0.82) and without CKD (RR = 0.67, 95% CI: 0.55–0.92), while patients with unsuccessful fibrinolysis had a similarly higher risk in CKD patients (RR = 1.25, 95% CI: 1.09–1.43) and non-CKD patients (RR = 1.30, 95% CI: 1.13–1.50). CKD reduced the likelihood of successful fibrinolysis and increased the risk of short-term MACEs in patients with STEMI. Attention should be paid to how to improve the success rate of fibrinolytic therapy for STEMI patients with CKD. The CPACS-3 study was registered on www.clinicaltrials.gov ( NCT01398228 ).
Publisher: BMJ
Date: 03-2017
DOI: 10.1136/HEARTJNL-2016-310216
Abstract: To quantify contemporary differences in cardiovascular disease (CVD) risk factor assessment and management between women and men in Australian primary healthcare services. Records of routinely attending patients were s led from 60 Australian primary healthcare services in 2012 for the Treatment of Cardiovascular Risk using Electronic Decision Support study. Multivariable logistic regression models were used to compare the rate of CVD risk factor assessment and recommended medication prescriptions, by gender. Of 53 085 patients, 58% were female. Adjusting for demographic and clinical characteristics, women were less likely to have sufficient risk factors measured for CVD risk assessment (OR (95% CI): 0.88 (0.81 to 0.96)). Among 13 294 patients (47% women) in the CVD/high CVD risk subgroup, the adjusted odds of prescription of guideline-recommended medications were greater for women than men: 1.12 (1.01 to 1.23). However, there was heterogeneity by age (p <0.001), women in the CVD/high CVD risk subgroup aged 35-54 years were less likely to be prescribed the medications (0.63 (0.52 to 0.77)), and women in the CVD/high CVD risk subgroup aged ≥65 years were more likely to be prescribed the medications (1.34 (1.17 to 1.54)) than their male counterparts. Women attending primary healthcare services in Australia were less likely than men to have risk factors measured and recorded such that absolute CVD risk can be assessed. For those with, or at high risk of, CVD, the prescription of appropriate preventive medications was more frequent in older women, but less frequent in younger women, compared with their male counterparts. 12611000478910, Pre-results.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2014
DOI: 10.1161/CIRCOUTCOMES.113.000527
Abstract: Organizational and wider health system factors influence the implementation and success of interventions. Clinical Pathways in Acute Coronary Syndromes 2 is a cluster randomized trial of a clinical pathway–based intervention to improve acute coronary syndrome care in hospitals in China. We performed a qualitative evaluation to examine the system-level barriers to implementing clinical pathways in the dynamic healthcare environment of China. A qualitative descriptive analysis of 40 in-depth interviews with health professionals conducted in a s le of 10 hospitals purposively selected to explore barriers to implementation of the intervention. Qualitative data were analyzed using the Framework method. In-depth interviews identified 5 key system-level barriers to effective implementation: (1) leadership support for implementing quality improvement, (2) variation in the capacity of clinical services and quality improvement resources, (3) fears of patient disputes and litigation, (4) healthcare funding constraints and high out-of-pocket expenses, and (5) patient-related factors. System-level barriers affect the ability of acute coronary syndrome clinical pathways to change practice. Addressing these barriers in the context of current and planned national health system reform will be critical for future improvements in the management of acute coronary syndromes, and potentially other hospitalized conditions, in China. URL: www.anzctr.org.au/default.aspx . Register. Unique identifier: ACTRN12609000491268.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2014
DOI: 10.1161/CIRCOUTCOMES.113.000526
Abstract: Substantial evidence-practice gaps exist in the management of acute coronary syndromes (ACS) in China. Clinical pathways are tools for improving ACS quality of care but have not been rigorously evaluated. Between October 2007 and August 2010, a quality improvement program was conducted in 75 hospitals throughout China with mixed methods evaluation in a cluster randomized, controlled trial. Eligible hospitals were level 2 or level 3 centers routinely admitting patients with ACS per year. Hospitals were assigned immediate implementation of the American Heart Association/American College of Cardiology guideline based clinical pathways or commencement of the intervention 12 months later. Outcomes were several key performance indicators reflecting the management of ACS. The key performance indicators were measured 12 months after commencement in intervention hospitals and compared with baseline data in control hospitals, using data collected from 50 consecutive patients in each hospital. Pathway implementation was associated with an increased proportion of patients discharged on appropriate medical therapy, with nonsignificant improvements or absence of effects on other key performance indicators. Among hospitals in China, the use of a clinical pathway for the treatment of ACS compared with usual care improved secondary prevention treatments, but effectiveness was otherwise limited. An accompanying process evaluation identified several health system barriers to more successful implementation. URL: www.anzctr.org.au/default.aspx . Unique identifier: ACTRN12609000491268.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2014
DOI: 10.1161/HYPERTENSIONAHA.113.02252
Abstract: The objective of the present analysis was to determine the effects of a fixed combination of perindopril and indapamide in combination with calcium channel blockers (CCBs) in patients with type 2 diabetes mellitus. The Action in Diabetes and Vascular Disease: Preterax and Diamicron Controlled Evaluation (ADVANCE) trial was a factorial randomized controlled trial. A total of 11 140 patients with type 2 diabetes mellitus were randomly assigned to fixed combination of perindopril–indapamide (4/1.25 mg) or placebo. Effects of randomized treatment on mortality and major cardiovascular outcomes were examined in subgroups defined by baseline use of CCBs. Patients on CCB at baseline (n=3427) constituted a higher risk group compared with those not on CCB (n=7713), with more extensive use of antihypertensive and other protective therapies. Active treatment reduced the relative risk of death by 28% (95% confidence interval, 10%–43%) among patients with CCB at baseline compared with 5% (−12% to 20%) among those without CCB ( P homogeneity=0.02) and 14% (2%–25%) for the whole population. Similarly, the relative risk reduction for major cardiovascular events was 12% (−8% to 28%) versus 6% (−10% to 19%) for those with and without CCB at baseline although the difference was not statistically significant ( P homogeneity=0.38). There was no detectable increase in adverse effects in those receiving CCB. The combination of perindopril and indapamide with CCBs seems to provide further protection against mortality in patients with type 2 diabetes mellitus.
Publisher: BMJ
Date: 11-2022
DOI: 10.1136/BMJGH-2022-009762
Abstract: The WHO has warned that substandard and falsified medicines threaten health, especially in low and middle-income countries (LMICs). However, the magnitude of that threat for many medicines in different regions is not well described, and high-quality studies remain rare. Recent reviews of studies of cardiovascular and diabetes medicine quality recorded that 15.4% of cardiovascular and 6.8% of diabetes s les failed at least one quality test. Review authors warn that study quality was mixed. Because they did not record medicine volume, no study reflected the risk posed to patients. We investigated the quality of five medicines for cardiovascular disease and diabetes in Malang district, East Java, Indonesia. Our s le frame, based on dispensing volumes by outlet and price category, included s ling from public and private providers and pharmacies and reflected the potential risk posed to patients. The content of active ingredient was determined by high-performance liquid chromatography and compared with the labelled content. Dissolution testing was also performed. We collected a total of 204 s les: amlodipine (88) captopril (22) furosemide (21) glibenclamide (21) and simvastatin (52), comprising 83 different brands roducts. All were manufactured in Indonesia, and all s les met specifications for both assay and dissolution. None was suspected of being falsified. While we cannot conclude that the prevalence of poor-quality medicines in Malang district is zero, our s ling method, which reflects likely exposure to specific brands and outlets, suggests that the risk to patients is very low certainly nothing like the rates found in recent reviews of surveys in LMICs. Our study demonstrates the feasibility of s ling medicines based on likely exposure to specific products and underlines the dangers of extrapolating results across countries.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2010
Publisher: Springer Science and Business Media LLC
Date: 15-11-2018
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: 08-2008
Publisher: Oxford University Press (OUP)
Date: 13-03-2021
Abstract: Cardiovascular diseases (CVD) are the leading cause of death in Indonesia, and there are large disparities in access to recommended preventative treatments across the country, particularly in rural areas. Technology-enabled screening and management led by community health workers have been shown to be effective in better managing those at high risk of CVD in a rural Indonesian population however, the economic impacts of implementing such an intervention are unknown. We conducted a modelled cost-effectiveness analysis of the SMARThealth intervention in rural villages of Malang district, Indonesia from the payer perspective over a 10-year period. A Markov model was designed and populated with epidemiological and cost data collected in a recent quasi-randomized trial, with nine health states representing a differing risk for experiencing a major CVD event. Disability-Adjusted Life Years (DALYs) were estimated for the intervention and usual care using disability weights from the literature for major CVD events. Annual treatment costs for CVD treatment and prevention were $US83 under current care and $US144 for those receiving the intervention. The intervention had an incremental cost-effectiveness ratio of $4288 per DALY averted and $3681 per major CVD event avoided relative to usual care. One-way and probabilistic sensitivity analyses demonstrated that the results were robust to plausible variations in model parameters and that the intervention is highly likely to be considered cost-effective by decision-makers across a range of potentially acceptable willingness to pay levels. Relative to current care, the intervention was a cost-effective means to improve the management of CVD in this rural Indonesian population. Further scale-up of the intervention offers the prospect of significant gains in population health and sustainable progress toward universal health coverage for the Indonesian population.
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: Oxford University Press (OUP)
Date: 08-2003
DOI: 10.1093/IJE/DYG106
Abstract: Cholesterol levels in many Asian countries are rising. Predictions of the likely effects of this on the incidence of cardiovascular diseases have mostly relied on data from Western populations. Whether the associations between total cholesterol and cardiovascular diseases are similar in Asia is not established. The Asia Pacific Cohort Studies Collaboration (APCSC) is an in idual-participant data meta-analysis of prospective studies from the Asia-Pacific region. Cox models were applied to the combined data from 29 cohorts to estimate the region-, sex-, and age-specific hazard ratios of major cardiovascular diseases by the fifths of total cholesterol. At baseline, the age/sex-adjusted mean value of total cholesterol was higher in Australia and New Zealand (ANZ) (5.52 +/- 1.05 mmol/l) than in Asia (4.87 +/- 1.05 mmol/l). During 2 million person-years of follow-up among 352 033 in iduals, 4841 cardiovascular deaths were recorded. The association of total cholesterol with coronary heart disease and stroke was similar in Asian and ANZ cohorts. Overall, each 1-mmol/l higher level of total cholesterol was associated with 35% (95% CI: 26-44%) increased risk of coronary death, 25% (95% CI: 13-40%) increased risk of fatal or non-fatal ischaemic stroke, and 20% (95% CI: 8-30%) decreased risk of fatal haemorrhagic stroke. In both Asian and non-Asian populations in the Asia-Pacific region, total cholesterol is similarly strongly associated with the risk of CHD and ischaemic, but not haemorrhagic, stroke. Rising population-wide levels of cholesterol would be expected to contribute to a substantial increase in the overall burden of cardiovascular diseases in this region.
Publisher: Wiley
Date: 17-03-2016
DOI: 10.1111/DME.13102
Abstract: To investigate the distribution of and risk factors for dysglycaemia (Type 2 diabetes and prediabetes) in women with previous gestational diabetes mellitus in India. All women (n = 989) from two obstetric units in New Delhi and Hyderabad with a history of gestational diabetes were invited to participate, of whom 366 (37%) agreed. Sociodemographic, medical and anthropometric data were collected and 75-g oral glucose tolerance test were carried out. Within 5 years (median 14 months) of the pregnancy in which they were diagnosed with gestational diabetes, 263 (72%) women were dysglycaemic, including 119 (32%) and 144 (40%) with Type 2 diabetes and prediabetes, respectively. A higher BMI [odds ratio 1.16 per 1-kg/m The high post-pregnancy conversion rates of gestational diabetes to diabetes reported in the present study reinforce the need for mandatory postpartum screening and identification of strategies for preventing progression to Type 2 diabetes. Use of the American Diabetes Association-recommended HbA
Publisher: Walter de Gruyter GmbH
Date: 28-08-2018
DOI: 10.1515/REVNEURO-2017-0072
Abstract: Gut microbiome ersity has been strongly associated with mood-relating behaviours, including major depressive disorder (MDD). This association stems from the recently characterised bi-directional communication system between the gut and the brain, mediated by neuroimmune, neuroendocrine and sensory neural pathways. While the link between gut microbiome and depression is well supported by research, a major question needing to be addressed is the causality in the connection between the two, which will support the understanding of the role that the gut microbiota play in depression. In this article, we address this question by examining a theoretical ‘chronology’, reviewing the evidence supporting two possible sequences of events. First, we discuss that alterations in the gut microbiota populations of specific species might contribute to depression, and secondly, that depressive states might induce modification of specific gut microbiota species and eventually contribute to more severe depression. The feasibility of both sequences is supported by pre-clinical trials. For instance, research in rodents has shown an onset of depressive behaviour following faecal transplantations from patients with MDD. On the other hand, mental induction of stress and depressive behaviour in rodents resulted in reduced gut microbiota richness and ersity. Synthesis of these chronology dynamics raises important research directions to further understand the role that gut microbiota play in mood-relating behaviours, which holds substantial potential clinical outcomes for persons who experience MDD or related depressive disorders.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2011
Publisher: BMJ
Date: 20-10-2008
DOI: 10.1136/BMJ.A2162
Publisher: Elsevier BV
Date: 06-2018
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: 19-06-2007
Publisher: Elsevier BV
Date: 2021
Publisher: Elsevier BV
Date: 08-2017
DOI: 10.1016/J.IJCARD.2017.03.057
Abstract: Prevention of repeat cardiovascular events is an important means of addressing the increasing burden of coronary heart disease in China, however there is minimal information about the use of cardiovascular prevention treatment following acute coronary syndrome (ACS) in China. We analysed data from baseline and 6, 12, 18, and 24-month follow-up surveys of 15,140 consecutive ACS patients recruited in 70 hospitals from 17 provinces of China. We describe the use of indicated cardiovascular prevention medicines, risk factor control, change over time and factors associated with continued prevention. 12,094 patients had follow-up data up to 12months. At discharge, 86.1% were on a combination of antiplatelet, statin and blood pressure (BP) lowering drugs. Use of this combination fell to 68.0% at 12months and 59.7% in patients followed to 24months. Patients admitted to tertiary hospitals were more likely to be on the combination compared to secondary hospitals (at discharge 90.1% vs. 79.5%, p<0.0001 at 12months 71% vs. 64%, p<0.001 respectively). At 12months 25.2% achieved control in ≥four of five guideline levels of risk factors and this was similar by hospital level. Prescription of BP-lowering drugs and statins at discharge was the strongest predictor of use at 12months follow-up. Lower income was associated with less use of both. Use of cardiovascular prevention treatment declines steadily over time following an ACS. The largest proportional decline is in the first six months. Ensuring patients are discharged on these therapies and addressing barriers for low-income earners may help address this gap.
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: 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: American College of Physicians
Date: 03-11-2009
DOI: 10.7326/0003-4819-151-9-200911030-00008
Abstract: Intravenous sodium bicarbonate has been proposed to reduce the risk for contrast-induced nephropathy (CIN). To determine the effect of sodium bicarbonate on the risk for CIN. MEDLINE, PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials from 1950 to December 2008 conference proceedings and ClinicalTrials.gov, without language restriction. Randomized, controlled trials of intravenous sodium bicarbonate that prespecified the outcome of CIN as a 25% increase in baseline serum creatinine level or an absolute increase of 44 micromol/L (0.5 mg/dL) after radiocontrast administration. Using standardized protocols, 2 reviewers serially abstracted data for each study. 23 published and unpublished trials with information on 3563 patients and 396 CIN events were included. The pooled relative risk was 0.62 (95% CI, 0.45 to 0.86), with evidence of significant heterogeneity across studies (I(2) = 49.1% P = 0.004). Some heterogeneity was due to the difference in the estimates between published and unpublished studies: relative risk, 0.43 (CI, 0.25 to 0.75) versus 0.78 (CI, 0.52 to 1.17), respectively. Meta-regression showed that small, poor-quality studies that assessed outcomes soon after radiocontrast administration were more likely to suggest benefit (P < 0.05 for all). No clear effects of treatment on the risk for dialysis, heart failure, and total mortality were identified. Power to assess clinical end points was limited. The effectiveness of sodium bicarbonate treatment to prevent CIN in high-risk patients remains uncertain. Earlier reports probably overestimated the magnitude of any benefit, whereas larger, more recent trials have had neutral results. Large multicenter trials are required to clarify whether sodium bicarbonate has value for prevention of CIN before routine use can be recommended. None.
Publisher: Elsevier BV
Date: 09-2007
Publisher: Elsevier BV
Date: 05-2010
Publisher: AMPCo
Date: 03-2010
DOI: 10.5694/J.1326-5377.2010.TB03502.X
Abstract: To examine the perception and management of cardiovascular disease (CVD) risk in Australian primary care. The Australian Hypertension and Absolute Risk Study (AusHEART) was a nationally representative, cluster-stratified, cross-sectional survey of 322 general practitioners. Each GP was asked to collect data on CVD risk factors and their management in 15-20 consecutive patients aged >or= 55 years who presented between April and June 2008, and to estimate each patient's absolute risk of a cardiovascular event in the next 5 years. Estimated 5-year risk of a cardiovascular event, proportion of patients receiving appropriate treatment. Among 5293 patients, 29% (1548) had established CVD. A further 22% (1145), when categorised according to the 2009 National Vascular Disease Prevention Alliance guideline, to 42% (2211), when categorised according to National Heart Foundation (NHF) 2004 guideline, had a high (>or= 15%) 5-year risk of a cardiovascular event. Of the 1548 patients with established CVD, 50% were prescribed a combination of a blood pressure (BP)-lowering medication, a statin and an antiplatelet agent, and 9% were prescribed a BP-lowering medication and a statin but not an antiplatelet agent. Among high-risk patients without established CVD, categorised using NHF 2004 adjustments, 34% were prescribed a combination of a BP-lowering medication and a statin. GPs estimated 60% of patients with established CVD as having a risk of less than 15%. The GPs' estimates of risk among patients without established CVD agreed with the centrally calculated estimate (according to the NHF 2004 guideline) in 48% of instances (Kappa = 0.21). These data confirm substantial undertreatment of patients who are at high risk of a cardiovascular event. We recommend that GPs assess absolute risk for older patients and ensure that high-risk patients receive evidence-based pharmacotherapy.
Publisher: Springer Science and Business Media LLC
Date: 21-04-2011
DOI: 10.1007/S00125-011-2104-X
Abstract: Type 2 diabetes has been associated with an increased risk of cancer. This study examines the effect of more vs less intensive glucose control on the risk of cancer in patients with type 2 diabetes. All 11,140 participants from the Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE) trial (ClinicalTrials.gov NCT00145925) were studied. Cancer incidence and cancer mortality was compared in groups randomised to intensive or standard glucose control. Information on events during follow-up was obtained from serious adverse event reports and death certificates. HRs (95% CI) were calculated for all cancers, all solid cancers, cancer deaths and site-specific cancers. After a median follow-up of 5 years, 363 and 337 cancer events were reported in the intensive and standard control groups, respectively (incidence 1.39/100 person-years [PY] and 1.28/100 PY HR 1.08 [95% CI 0.93-1.26]). The incidences of all solid cancers and cancer deaths were 1.25/100 PY and 0.55/100 PY in the intensive group and 1.15/100 PY and 0.63/100 PY in the standard group (HR 1.09[95% CI 0.93–1.27] for solid cancers, and 0.88 [0.71–1.10] for cancer death) [corrected].Across all the major organ systems studied, no significant differences in the cancer incidences were observed in the intensive and standard control groups. More intensive glucose control achieved with a regimen that included greater use of gliclazide, insulin, metformin and other agents, did not affect the risk of cancer events or death in patients with type 2 diabetes.
Publisher: Cambridge University Press (CUP)
Date: 2015
DOI: 10.1017/GMH.2015.11
Abstract: India has few mental health professionals to treat the large number of people suffering from mental disorders. Rural areas are particularly disadvantaged due to lack of trained health workers. Ways to improve care could be by training village health workers in basic mental health care, and by using innovative methods of service delivery. The ongoing Systematic Medical Appraisal, Referral and Treatment Mental Health Programme will assess the acceptability, feasibility and preliminary effectiveness of a task-shifting mobile-based intervention using mixed methods, in rural Andhra Pradesh, India. The key components of the study are an anti-stigma c aign followed by a mobile-based mental health services intervention. The study will be done across two sites in rural areas, with intervention periods of 1 year and 3 months, respectively. The programme uses a mobile-based clinical decision support tool to be used by non-physician health workers and primary care physicians to screen, diagnose and manage in iduals suffering from depression, suicidal risk and emotional stress. The key aim of the study will be to assess any changes in mental health services use among those screened positive following the intervention. A number of other outcomes will also be assessed using mixed methods, specifically focussed on reduction of stigma, increase in mental health awareness and other process indicators. This project addresses a number of objectives as outlined in the Mental Health Action Plan of World Health Organization and India's National Mental Health Programme and Policy. If successful, the next phase will involve design and conduct of a cluster randomised controlled trial.
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: Elsevier BV
Date: 12-2019
Publisher: Springer Science and Business Media LLC
Date: 02-11-2011
Abstract: In winemaking, nutrient supplementation is a common practice for optimising fermentation and producing quality wine. Nutritionally suboptimal grape juices are often enriched with nutrients in order to manipulate the production of yeast aroma compounds. Nutrients are also added to active dry yeast (ADY) rehydration media to enhance subsequent fermentation performance. In this study we demonstrate that nutrient supplementation at rehydration also has a significant effect on the formation of volatile sulfur compounds during wine fermentations. The concentration of the 'fruity' aroma compounds, the polyfunctional thiols 3-mercaptohexan-1-ol (3MH) and 3-mercaptohexyl acetate (3MHA), was increased while the concentration of the 'rotten egg' aroma compound, hydrogen sulfide (H 2 S), was decreased. Nutrient supplementation of the rehydration media also changed the kinetics of H 2 S production during fermentation by advancing onset of H 2 S production. Microarray analysis revealed that this was not due to expression changes within the sulfate assimilation pathway, which is known to be a major contributor to H 2 S production. To gain insight into possible mechanisms responsible for this effect, a component of the rehydration nutrient mix, the tri-peptide glutathione (GSH) was added at rehydration and studied for its subsequent effects on H 2 S formation. GSH was found to be taken up during rehydration and to act as a source for H 2 S during the following fermentation. These findings represent a potential approach for managing sulfur aroma production through the use of rehydration nutrients.
Publisher: BMJ
Date: 08-01-2009
Publisher: Elsevier BV
Date: 04-2023
DOI: 10.1016/J.TCM.2021.12.013
Abstract: Fixed-dose combination (FDC) therapies (also known as polypills) remain underutilized in clinical practice despite over two decades of evidence from randomized controlled trials demonstrating increased adherence to multidrug therapy, improved cardiovascular disease (CVD) risk factor control, and lower incidence of cardiovascular events. Evidence demonstrates that FDC-based implementation strategies can substantially complement and augment current strategies for CVD risk prevention globally. The next decade is likely to extend the frontier of cardiovascular FDC therapies, particularly given expected advances in FDC manufacturing technology and accessibility. FDC-based anti-hypertensive therapies are emerging as integral components of a pragmatic blood pressure lowering strategy. Cardiovascular FDCs are rapidly approaching its coming of age, transforming from heavily hyped research tools to pragmatic clinical instruments. This review evaluates the current evidence for cardiovascular FDCs, barriers to current use, and potential next generation advances.
Publisher: Wiley
Date: 17-01-2010
Publisher: Elsevier BV
Date: 10-2019
Publisher: Massachusetts Medical Society
Date: 21-01-2021
DOI: 10.1056/NEJME2033310
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.
Publisher: AMPCo
Date: 09-2010
DOI: 10.5694/J.1326-5377.2010.TB03941.X
Abstract: To determine the cost-effectiveness of routine administration, irrespective of blood pressure (BP), of a fixed-dose combination of perindopril and indapamide to patients with type 2 diabetes mellitus. Prospective cost-effectiveness analysis within the Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE) trial, an international, multicentre, randomised controlled trial of 11,140 participants with type 2 diabetes randomly allocated to receive perindopril plus indapamide (4 mg-1.25 mg/day) or placebo. Health-related quality-of-life measured by the EuroQol-5D, resource utilisation, and cost-effectiveness (cost per death averted at 4.3 years' average follow-up, and estimated cost per life-year gained, by extrapolation). The mean health-related quality-of-life score of survivors was 0.80 (on a 0-1 scale [death to full health]), with no difference between treatment groups. Active treatment reduced hospital admissions for coronary heart disease and coronary revascularisation by 5%. For the Australian participants, perindopril-indapamide cost A$1368 per patient during the trial period, but reduced total hospitalisation costs by A$410 and other medication costs (mainly other BP-lowering drugs) by A$332. The absolute reduction in all-cause mortality for the active treatment group was 1.1%, giving a cost per life saved of A$49,200. Lifetime extrapolation gave an estimated cost per life-year saved of A$10,040 (discounted at 5% per year). The combination of perindopril and indapamide in patients with type 2 diabetes appears to be cost-effective. United States National Library of Medicine NCT00145925.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 26-10-2004
DOI: 10.1161/01.CIR.0000145615.33955.83
Abstract: Background— The importance of serum triglyceride levels as a risk factor for cardiovascular diseases is uncertain. Methods and Results— We performed an in idual participant data meta-analysis of prospective studies conducted in the Asia-Pacific region. Cox models were applied to the combined data from 26 studies to estimate the overall and region-, sex-, and age-specific hazard ratios for major cardiovascular diseases by fifths of triglyceride values. During 796 671 person-years of follow-up among 96 224 in iduals, 670 and 667 deaths as a result of coronary heart disease (CHD) and stroke, respectively, were recorded. After adjustment for major cardiovascular risk factors, participants grouped in the highest fifth of triglyceride levels had a 70% (95% CI, 47 to 96) greater risk of CHD death, an 80% (95% CI, 49 to 119) higher risk of fatal or nonfatal CHD, and a 50% (95% CI, 29% to 76%) increased risk of fatal or nonfatal stroke compared with those belonging to the lowest fifth. The association between triglycerides and CHD death was similar across subgroups defined by ethnicity, age, and sex. Conclusions— Serum triglycerides are an important and independent predictor of CHD and stroke risk in the Asia-Pacific region. These results may have clinical implications for cardiovascular risk prediction and the use of lipid-lowering therapy.
No related grants have been discovered for Anushka Patel.