ORCID Profile
0000-0003-1282-1896
Current Organisations
George Institute for Global Health
,
UNSW Sydney
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Publisher: Cold Spring Harbor Laboratory
Date: 02-11-2019
DOI: 10.1101/19010785
Abstract: Type 2 diabetes increases the risk of cardiovascular and renal complications, but early risk prediction can lead to timely intervention and better outcomes. Through summary statistics of meta-analyses of published genome-wide association studies performed in over 1.2 million of in iduals, we combined 9 PRS gathering genomic variants associated to cardiovascular and renal diseases and their key risk factors into one logistic regression model, to predict micro- and macrovascular endpoints of diabetes. Its clinical utility in predicting complications of diabetes was tested in 4098 participants with diabetes of the ADVANCE trial followed during a period of 10 years and replicated it in three independent non-trial cohorts. The prediction model adjusted for ethnicity, sex, age at onset and diabetes duration, identified the top 30% of ADVANCE participants at 3.1-fold increased risk of major micro- and macrovascular events (p=6.3×10 −21 and p=9.6×10 −31 , respectively) and at 4.4-fold (p=6.8×10 −33 ) increased risk of cardiovascular death compared to the remainder of T2D subjects. While in ADVANCE overall, combined intensive therapy of blood pressure and glycaemia decreased cardiovascular mortality by 24%, the prediction model identified a high-risk group in whom this therapy decreased mortality by 47%, and a low risk group in whom the therapy had no discernable effect. Patients with high PRS had the greatest absolute risk reduction with a number needed to treat of 12 to prevent one cardiovascular death over 5 years. This novel polygenic prediction model identified people with diabetes at low and high risk of complications and improved targeting those at greater benefit from intensive therapy while avoiding unnecessary intensification in low-risk subjects.
Publisher: Wiley
Date: 25-02-2009
DOI: 10.1111/J.1526-4610.2009.01346.X
Abstract: Limited evidence suggests that, in in iduals with migraine, prior use of opioids reduces responsiveness to treatment with subsequent acute migraine therapies. The evidence is more robust with regard to opioids as a risk factor for chronic migraine. To explore whether recent prior opioid use influenced treatment response, in a post hoc pooled analysis of rizatriptan clinical trials. We included rizatriptan 10 mg and placebo data from phase 3 moderate/severe migraine studies as well as from the rizatriptan "Treat a Migraine Early" (TAME) studies. As part of the clinical assessment, medication usage for migraine and other reasons in the 30 days prior to a screening visit and up to the time of taking study drug was captured via patient's self-report. The influence of recent prior opioid use on the endpoint of pain freedom at 2 hours was assessed via logistic regression. We further explored the influence of gender and disability on treatment response. In the moderate/severe migraine studies of 2068 in iduals treated with rizatriptan, 284 (13.7%) reported recent prior use of opioids. Of those treated with placebo (1258), 12.5% recently used opioids. In the TAME studies, the proportions were lower, 3.9% and 5.3%, respectively. The pretreatment and demographic characteristics were similar across the study groups. In the moderate/severe studies, recent prior opioid use was associated with reduced 2-hour pain freedom. Although the influence of recent prior opioid use was assessed independently of treatment, the finding was driven primarily by rizatriptan (recent prior use vs no use: 34% vs 42% for rizatriptan and 10% vs 10% for placebo P = .013). In the TAME studies, recent prior opioid use was also predictive of reduced efficacy (recent prior use vs no use: 41% vs 59% for rizatriptan and 13% vs 32% for placebo P = .007). Recent prior opioid use was associated with lower triptan response. Because of the post hoc nature of the analysis and limitations in capturing amount of opioid used, as well as to adjust for disability levels, these findings require replication in prospective studies.
Publisher: BMJ
Date: 02-2007
Publisher: Elsevier BV
Date: 12-2007
Publisher: Oxford University Press (OUP)
Date: 22-10-2006
DOI: 10.1093/IJE/DYL222
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: Oxford University Press (OUP)
Date: 04-02-2013
Abstract: In clinical practice, blood pressure (BP)-lowering agents are generally prescribed for use in the morning, whereas (short-acting) statins are recommended for use in the evening. There is evidence that the reduction in LDL cholesterol (LDL-c) achieved with short-acting statins is superior when taken in the evening and reported improvement in BP control when aspirin and BP-lowering agents are taken in the evening. However, it is unclear whether the additional reduction in LDL-c and BP is offset by a reduction in adherence, given that taking medication in the evening may be less typical or convenient. There is therefore uncertainty concerning the best timing of administration of a cardiovascular combination pill such as the polypill. The aim of TEMPUS (NCT01506505), a prospective randomized open blinded endpoint (PROBE) crossover trial, is to evaluate whether there is a difference in LDL-c levels or 24-hour ambulatory BP in in iduals at increased risk of cardiovascular disease when the cardiovascular polypill is taken in the evening compared to the morning. An additional aim is to assess the effect of the polypill on LDL-c and BP compared to the administration of separate pills of identically dosed components of the polypill. In total 75 participants with established cardiovascular disease or an intermediate to high risk for cardiovascular disease are randomly allocated to the sequence of three different treatments of 6-8 weeks: (1) the cardiovascular polypill (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, and hydrochlorothiazide 12.5 mg) in the evening (2) the polypill in the morning and (3) the use of the identically dosed agents in separate pills taken at different time points during the day. The primary endpoint is the difference in LDL-c and mean 24-hour ambulatory systolic BP. Secondary outcomes are the difference in relative risk reduction, biochemistry, platelet function and pulse wave analysis, participants' adherence, and acceptability. TEMPUS will evaluate the effect of timing of the administration of a cardiovascular polypill on LDL-c and BP measurements in patients with an intermediate or high risk for cardiovascular disease.
Publisher: Elsevier BV
Date: 05-2021
Publisher: Wiley
Date: 05-1996
DOI: 10.1111/J.1440-1681.1996.TB02758.X
Abstract: 1. Among patients with cerebrovascular disease, there is a direct and continuous association between blood pressure and the risk of stroke, but previous trials of blood pressure lowering in this patient group have been inconclusive. 2. PROGRESS (Perindopril Protection Against Recurrent Stroke Study) is a multicentre, randomized, placebo-controlled trial that aims to determine reliably the effect of angiotensin converting enzyme (ACE) inhibitor-based blood pressure lowering on stroke risk in patients with a history of cerebrovascular disease. If a 4 week run-in period on active perindopril is well tolerated, participants are randomized to either perindopril (4 mg) +/- indapamide (2.5 mg) or matching placebo(s). The primary study outcome is stroke and follow-up is for a minimum of 4 years. 3. For the pilot study nearly 5000 medical records were screened and 60 patients with recent cerebrovascular events were approached directly in hospital or at a clinic visit. Sixty-seven patients entered the run-in phase (52 from retrospective screening and 15 by prospective approach) and 60 patients proceeded to randomization. Treatment with perindopril was well tolerated only three patients were withdrawn due to side effects and four were withdrawn for other reasons. The mean age of randomized patients was 68 years 70% were male and 55% were 'non-hypertensive'. The mean entry blood pressure was 142/83 mmHg and following pre-randomization treatment this was reduced by 7/4 mmHg. 4. Most patients were identified by retrospective review of medical records, but this was less efficient than prospective methods. Blood pressure lowering was well tolerated by both hypertensive and non-hypertensive patients with cerebrovascular disease. The small numbers of patients and the non-randomized nature of the data reported limit the conclusions that can be drawn, but the results confirm the feasibility of the main study.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2019
Publisher: Wiley
Date: 05-2002
DOI: 10.1046/J.1445-2197.2002.02404.X
Abstract: A survey conducted in 1992 found that New Zealand orthopaedic surgeons relied on non-pharmacological methods of deep vein thrombosis prevention in most arthroplasty patients and almost all hip fracture patients. This survey was repeated in 1999 to ascertain whether this pattern of use had changed. All orthopaedic consultants in New Zealand who performed hip or knee surgery in 1999 were asked to complete a one-page postal questionnaire, asking for information regarding: the frequency with which chemoprophylaxis was employed in patients undergoing surgery for hip fracture, hip arthroplasty, or knee arthroplasty the drug regimes used the factors that influenced the choice of chemoprophylaxis and the factors that limited chemoprophylaxis use in orthopaedic practice. Between 1992 and 1999, the proportion of patients given chemoprophylaxis increased from 3% to 25% for patients with hip fracture, and from 32% to 57% for elective arthroplasty patients. The proportion of surgeons using low molecular weight heparin increased over the 7-year period from 55% to 76%,while aspirin use remained stable at 7% and standard heparin and warfarin decreased to less than 5%. There was a shift away from starting chemoprophylaxis preoperatively towards continuing until discharge, rather than until the patient was mobile. Opinions on indications and contraindications for chemoprophylaxis had not changed substantially during the 7-year period. Orthopaedic surgeons' use of chemoprophylaxis has increased in New Zealand. However, since hospital stays have decreased considerably and most orthopaedic patients are now discharged within a fortnight,prophylaxis may now cover a shorter duration of the at-risk period.
Publisher: BMJ
Date: 08-2006
Publisher: Elsevier BV
Date: 2015
Publisher: Oxford University Press (OUP)
Date: 09-04-2010
DOI: 10.1093/HER/CYQ029
Publisher: Wiley
Date: 24-03-2019
DOI: 10.1111/JCH.13522
Publisher: Public Library of Science (PLoS)
Date: 17-06-2021
DOI: 10.1371/JOURNAL.PMED.1003674
Abstract: Our knowledge of how to better manage elevated blood pressure (BP) in the presence of comorbidities is limited, in part due to exclusion or underrepresentation of patients with multiple chronic conditions from major clinical trials. We aimed to investigate the burden and types of comorbidities in patients with hypertension and to assess how such comorbidities and other variables affect BP levels over time. In this multiple landmark cohort study, we used linked electronic health records from the United Kingdom Clinical Practice Research Datalink (CPRD) to compare systolic blood pressure (SBP) levels in 295,487 patients (51% women) aged 61.5 (SD = 13.1) years with first recorded diagnosis of hypertension between 2000 and 2014, by type and numbers of major comorbidities, from at least 5 years before and up to 10 years after hypertension diagnosis. Time-updated multivariable linear regression analyses showed that the presence of more comorbidities was associated with lower SBP during follow-up. In hypertensive patients without comorbidities, mean SBP at diagnosis and at 10 years were 162.3 mm Hg (95% confidence interval [CI] 162.0 to 162.6) and 140.5 mm Hg (95% CI 140.4 to 140.6), respectively in hypertensive patients with ≥5 comorbidities, these were 157.3 mm Hg (95% CI 156.9 to 157.6) and 136.8 mm Hg (95% 136.4 to 137.3), respectively. This inverse association between numbers of comorbidities and SBP was not specific to particular types of comorbidities, although associations were stronger in those with preexisting cardiovascular disease. Retrospective analysis of recorded SBP showed that the difference in mean SBP 5 years before diagnosis between those without and with ≥5 comorbidities was −9 mm Hg (95% CI −9.7 to −8.3), suggesting that mean recorded SBP already differed according to the presence of comorbidity before baseline. Within 1 year after the diagnosis, SBP substantially declined, but subsequent SBP changes across comorbidity status were modest, with no evidence of a more rapid decline in those with more or specific types of comorbidities. We identified factors, such as prescriptions of antihypertensive drugs and frequency of healthcare visits, that can explain SBP differences according to numbers or types of comorbidities, but these factors only partly explained the recorded SBP differences. Nevertheless, some limitations have to be considered including the possibility that diagnosis of some conditions may not have been recorded, varying degrees of missing data inherent in analytical datasets extracted from routine health records, and greater measurement errors in clinical measurements taken in routine practices than those taken in well-controlled clinical study settings. BP levels at which patients were diagnosed with hypertension varied substantially according to the presence of comorbidities and were lowest in patients with multi-morbidity. Our findings suggest that this early selection bias of hypertension diagnosis at different BP levels was a key determinant of long-term differences in BP by comorbidity status. The lack of a more rapid decline in SBP in those with multi-morbidity provides some reassurance for BP treatment in these high-risk in iduals.
Publisher: BMJ
Date: 09-2015
Publisher: SAGE Publications
Date: 06-2023
DOI: 10.1177/03331024231183166
Abstract: Currently, only a few specific blood pressure-lowering medications are recommended for migraine prevention. Whether benefits extend to other classes or drugs is uncertain. Embase, MEDLINE, and the Cochrane Central Registry of Controlled Trials were searched for randomized control trials on the effect of blood pressure-lowering medications compared with placebo in participants with episodic migraine. Data were collected on four outcomes – monthly headache or migraine days, and monthly headache or migraine attacks, with a standardised mean difference calculated for overall. Random effect meta-analysis was performed. In total, 50 trials (70% of which were crossover) were included, comprising 60 comparisons. Overall mean age was 39 years, and 79% were female. Monthly headache days were fewer in all classes compared to placebo, and this was statistically significant for all but one class: alpha-blockers −0.7 (95% CI: −1.2, −0.1), angiotensin-converting enzyme inhibitors −1.3 (95% CI: −2.9, 0.2), angiotensin II receptor blockers −0.9 (−1.6, −0.1), beta-blocker −0.4 (−0.8, −0.0) and calcium channel blockers −1.8 (−3.4, −0.2). Standardised mean difference was significantly reduced for all drug classes and was separately significant for numerous specific drugs: clonidine, candesartan, atenolol, bisoprolol, metoprolol, propranolol, timolol, nicardipine and verapamil. Among people with episodic migraine, a broader number of blood pressure-lowering medication classes and drugs reduce headache frequency than those currently included in treatment guidelines. Trial Registration: The study was registered at PROSPERO (CRD42017079176).
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: Springer Science and Business Media LLC
Date: 14-04-2003
Abstract: Reliable and comparable analysis of risks to health is key for preventing disease and injury. Causal attribution of morbidity and mortality to risk factors has traditionally been conducted in the context of methodological traditions of in idual risk factors, often in a limited number of settings, restricting comparability.In this paper, we discuss the conceptual and methodological issues for quantifying the population health effects of in idual or groups of risk factors in various levels of causality using knowledge from different scientific disciplines. The issues include: comparing the burden of disease due to the observed exposure distribution in a population with the burden from a hypothetical distribution or series of distributions, rather than a single reference level such as non-exposed considering the multiple stages in the causal network of interactions among risk factor(s) and disease outcome to allow making inferences about some combinations of risk factors for which epidemiological studies have not been conducted, including the joint effects of multiple risk factors calculating the health loss due to risk factor(s) as a time-indexed "stream" of disease burden due to a time-indexed "stream" of exposure, including consideration of discounting and the sources of uncertainty.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2006
Publisher: American Academy of Pediatrics (AAP)
Date: 09-2004
Abstract: Objective. To determine whether prenatal exposure to betamethasone for the prevention of neonatal respiratory distress syndrome (RDS) alters blood pressure in childhood. Design. Prospective follow-up study of a randomized, double-blind, placebo-controlled trial. Setting. National Women's Hospital (Auckland, New Zealand). Participants. Two hundred twenty-three 6-year-old children of mothers who presented with unplanned premature labor and took part in a randomized, controlled trial of prenatal betamethasone therapy for the prevention of neonatal RDS. Intervention. Mothers received 2 doses of betamethasone (12 mg) or placebo, administered through intramuscular injection, 24 hours apart. Main Outcome Measures. Systolic and diastolic blood pressure at 6 years of age. Results. Children exposed prenatally to betamethasone (n = 121) did not differ in systolic or diastolic blood pressure from children exposed to placebo (n = 102) (mean difference: systolic: −1.6 mm Hg 95% confidence interval: −4.1 to 0.8 mm Hg diastolic: −0.3 mm Hg 95% confidence interval: −2.5 to 1.8 mm Hg). Conclusion. Prenatal exposure to betamethasone for prevention of neonatal RDS does not alter blood pressure at 6 years of age.
Publisher: Informa Healthcare
Date: 11-11-2016
Publisher: Wiley
Date: 09-2002
DOI: 10.1046/J.1468-1331.2002.00455.X
Abstract: The aim of the present meta-analysis was to determine a temporal pattern of occurrence of subarachnoid haemorrhage (SAH). A MEDLINE 1966-2001 and EMBASE (1980-2001) literature search and hand search of relevant references were performed for population-based incidence studies that reported the time of SAH occurrence. Data from all identified relevant studies were combined into a pooled rate ratio (RR), with corresponding 95% confidence intervals (CI) using the Mantel-Haenszel method. Overall, eight population-based studies were included in the analysis. A total of 2533 first-ever cases of SAH were reported in the studies identified. Risk of SAH occurrence was the highest in the period between 6 am and 12 am (RR = 3.19 95% CI 3.03-3.36 early morning as a reference variable) and between 12 p.m. and 6 p.m. (RR = 2.63 95% CI 2.47-2.80), in winter and spring (RR = 1.10 95% CI: 1.02-1.17 and RR = 1.07 95% CI: 1.01-1.13, respectively summer as a reference variable) and on Sunday (RR = 1.22 95% CI 1.09-1.37 Monday as a reference variable). The evidence suggests that occurrence of SAH exhibits a seasonal (winter and spring) peak, diurnal (late morning peak) and daily (Sunday peak) pattern. It is suggested that the occurrence of some major acute vascular events (total ischaemic strokes, intracerebral haemorrhage and myocardial infarction) may be influenced by common triggering factors.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2019
Publisher: Springer Science and Business Media LLC
Date: 26-11-2014
Publisher: Wiley
Date: 02-06-2017
DOI: 10.1111/JCPP.12753
Abstract: Depression often starts in adolescence making it an ideal time to intervene. We developed a universal cognitive behavioural therapy-based programme (MEMO CBT) to be delivered via multimedia mobile phone messages for teens. We conducted a prospective multicentre, randomised, placebo-controlled superiority trial in 15 high schools in Auckland, New Zealand, comparing MEMO CBT with a control programme [MEMO control] matched for intensity and type of message but with alternative content not targeting depression. The primary outcome was the change in score on the Children's Depression Rating Scale-Revised from baseline to 12 months. Secondary outcomes included the change in scores in the self-reported Reynold's Adolescent Depression Rating Scale-Second Edition, the Moods and Feelings Questionnaire, suicidal ideation using selected items from the Youth Risk Behaviour Survey, the Pediatric Quality of Life questionnaire, 12-month period prevalence of the diagnosis of depressive disorder using the Kiddie-Schedule for Affective Disorders and Schizophrenia, and students' ratings of their satisfaction with the programme. Eight hundred and fifty-five students (13-17 years old, mean 14.3 years) were randomly assigned to MEMO CBT (426) or to MEMO Control (429). Participants (68% female) had a mean CDRS-R at baseline of 21.5 (SD: 5). Overall 394 (93%) from the intervention group and 392 (91%) from the control group were followed up at 12 months. At the end of the intervention (approximately 9 weeks) the mean CDRS-R scores were 20.8 in the intervention group versus 20.4 in the control group, and at 12 months they were 22.4 versus 22.4 (p value for difference in change from baseline = 0.3). There was no obvious association between the amount of the intervention viewed by participants and outcomes. There was no evidence of benefit from the mobile phone CBT intervention compared with a control programme. Universal depression prevention remains a challenge.
Publisher: BMJ
Date: 02-2008
Abstract: To describe the methods, characteristics of participants, and report on the preliminary findings of a longitudinal study of cyclists. Web-based survey to establish a cohort of cyclists. Participants in the largest mass-participation bicycle event in New Zealand, the Wattyl Lake Taupo Cycle Challenge. 2469 riders who had enrolled online in the 2006 Wattyl Lake Taupo Cycle Challenge. Self-reported crashes in preceding 12 months. Of 5653 eligible riders, 2469 (44%) completed the study questionnaire. Mean age was 44 years, 73% were male, and the average number of kilometers cycled per week in the preceding 12 months was 130. The annual incidence of crashes leading to injury that disrupted usual daily activities for at least 24 h was 0.5 per cyclist/year. About one-third of these crashes resulted in presentation to a health professional. The mean number of days absent from work attributable to bicycle crashes was 0.39 per cyclist/year. After adjustment for potential confounders and exposure (kilometers cycled per year), the rate of days off work from bicycle crash injury was substantially lower among riders who reported always wearing fluorescent colors (multivariate incidence rate ratio 0.23, 95% CI 0.09 to 0.59). Low cyclist conspicuity may increase the risk of crash-related injury and subsequent time off work. Increased use of high-visibility clothing is a simple intervention that may have a large impact on the safety of cycling.
Publisher: American Medical Association (AMA)
Date: 04-2018
Publisher: Springer Science and Business Media LLC
Date: 19-05-2009
Abstract: Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention). An overview of the eGAME study is presented, providing an ex le of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Australian New Zealand Clinical Trials Registry ACTRN12607000632493
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2016
Publisher: Elsevier BV
Date: 2022
DOI: 10.2139/SSRN.4107711
Publisher: Springer Science and Business Media LLC
Date: 05-05-2021
Publisher: Public Library of Science (PLoS)
Date: 03-05-2005
Publisher: Wiley
Date: 03-2005
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-09-2022
Abstract: Published randomized controlled trials are underpowered for binary clinical end points to assess the safety and efficacy of renin‐angiotensin system inhibitors (RASi) in adults with COVID‐19. We therefore performed a meta‐analysis to assess the safety and efficacy of RASi in adults with COVID‐19. MEDLINE, EMBASE, ClinicalTrials.gov , and the Cochrane Controlled Trial Register were searched for randomized controlled trials that randomly assigned patients with COVID‐19 to RASi continuation/commencement versus no RASi therapy. The primary outcome was all‐cause mortality at ≤30 days. A total of 14 randomized controlled trials met the inclusion criteria and enrolled 1838 participants (aged 59 years, 58% men, mean follow‐up 26 days). Of the trials, 11 contributed data. We found no effect of RASi versus control on all‐cause mortality (7.2% versus 7.5% relative risk [RR], 0.95 [95% CI, 0.69–1.30]) either overall or in subgroups defined by COVID‐19 severity or trial type. Network meta‐analysis identified no difference between angiotensin‐converting enzyme inhibitors versus angiotensin II receptor blockers. RASi users had a nonsignificant reduction in acute myocardial infarction (2.1% versus 3.6% RR, 0.59 [95% CI, 0.33–1.06]), but increased risk of acute kidney injury (7.0% versus 3.6% RR, 1.82 [95% CI, 1.05–3.16]), in trials that initiated and continued RASi. There was no increase in need for dialysis or differences in congestive cardiac failure, cerebrovascular events, venous thromboembolism, hospitalization, intensive care admission, inotropes, or mechanical ventilation. This meta‐analysis of randomized controlled trials evaluating angiotensin‐converting enzyme inhibitors/angiotensin II receptor blockers versus control in patients with COVID‐19 found no difference in all‐cause mortality, a borderline decrease in myocardial infarction, and an increased risk of acute kidney injury with RASi. Our findings provide strong evidence that RASi can be used safely in patients with COVID‐19.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2004
Publisher: Informa UK Limited
Date: 1993
DOI: 10.3109/10641969309037085
Abstract: Direct evidence about the effects of antihypertensive treatment on vascular disease in older patients is available from five randomized trials conducted exclusively in patients over the age of 60 years. These trials involved a total of 12,483 in iduals with systolic or diastolic hypertension (mean age = 72 years, mean entry blood pressure = 181/88 mmHg). Over an average follow-up period of 4.7 years, a 15/6 mmHg difference in blood pressure between study and control groups was achieved. Among those patients assigned active treatment, stroke incidence was reduced by 34% SD6 and coronary heart disease incidence was reduced by 19% SD7. These proportional reductions were of similar size to those observed in trials in predominantly younger patients. However, the absolute benefits observed in older patients were more than twice as great as those observed in younger patients. The results suggest that over 10 years, treatment would prevent at least one major vascular event among every 10 elderly patients at similar risk to those enrolled in the trials.
Publisher: BMJ
Date: 05-09-2005
Publisher: Elsevier BV
Date: 07-2011
Abstract: Sedentary activities such as video gaming are independently associated with obesity. Active video games, in which players physically interact with images on screen, may help increase physical activity and improve body composition. The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight, body composition, physical activity, and physical fitness. We conducted a 2-arm, parallel, randomized controlled trial in Auckland, New Zealand. A total of 322 overweight and obese children aged 10-14 y, who were current users of sedentary video games, were randomly assigned at a 1:1 ratio to receive either an active video game upgrade package (intervention, n = 160) or to have no change (control group, n = 162). The primary outcome was the change from baseline in body mass index (BMI in kg/m(2)). Secondary outcomes were changes in percentage body fat, physical activity, cardiorespiratory fitness, video game play, and food snacking. At 24 wk, the treatment effect on BMI (-0.24 95% CI: -0.44, -0.05 P = 0.02) favored the intervention group. The change (±SE) in BMI from baseline increased in the control group (0.34 ± 0.08) but remained the same in the intervention group (0.09 ± 0.08). There was also evidence of a reduction in body fat in the intervention group (-0.83% 95% CI: -1.54%, -0.12% P = 0.02). The change in daily time spent playing active video games at 24 wk increased (10.03 min 95% CI: 6.26, 13.81 min P < 0.0001) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games (-9.39 min 95% CI: -19.38, 0.59 min P = 0.06). An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children. This trial was registered in the Australian New Zealand Clinical Trials Registry at www.anzctr.org.au/ as ACTRN12607000632493.
Publisher: Oxford University Press (OUP)
Date: 08-03-2017
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: Elsevier BV
Date: 10-2016
DOI: 10.1016/J.CLINTHERA.2016.08.007
Abstract: This article summarizes the results of a recent systematic review and meta-analysis of the safety and efficacy of intensive blood pressure (BP) lowering, including an update with the SPRINT (Systolic Blood Pressure Intervention Trial) results. We discuss the consistency of results within this set of trials (eg, ACCORD [Action to Control Cardiovascular Risk in Diabetes] and SPRINT) and the results in the context of other BP-lowering trials, including the recently published HOPE3 (Heart Outcomes Prevention Evaluation-3) study. This study was a narrative review with updated meta-analysis from systematic review of trials comparing more- versus less-intensive BP lowering. With the addition of SPRINT, there are >20 trials comparing more- versus less-intensive treatment with 54,350 participants overall. Over an average of 3.9 years of follow-up, the average systolic BP was 133 mm Hg in the more-intensive treatment arms and 140 mm Hg in the less-intensive treatment arms. More-intensive BP lowering reduced the risk of major vascular events, with benefits seen across a range of groups defined according to baseline systolic BP (120-139 mm Hg, 140-159 mm Hg, or ≥160 mm Hg), age ( 70 years), and main entry criterion (hypertension, diabetes, or renal disease). The evidence accumulated thus far provides clear evidence of the benefits of BP lowering in the 120- to 140-mm Hg range for various high-risk patient groups. Although intensive BP lowering has side effects, these trials indicate that the benefits will predominate for those at high risk of major vascular events.
Publisher: Wiley
Date: 03-1994
DOI: 10.1111/J.1445-2197.1994.TB02170.X
Abstract: A survey was conducted of the attitudes and practices of New Zealand orthopaedic surgeons on the use of pharmacological thromboprophylaxis (PT) for patients undergoing major hip or knee surgery. A questionnaire was sent to all 106 consultant surgeons known to perform hip or knee surgery and a response rate of 89% was obtained. The results suggested that while almost all surgeons used PT at some time, only about one-third of elective surgery patients and just a few per cent of patients with neck of femur fracture (NOFF) receive PT. For about three-quarters of surgeons, heparin (usually low molecular weight) was the most frequently used PT. About half of the surgeons began prophylaxis pre-operatively and about half stopped it when the patients were mobile postoperatively. Previous venous thromboembolism was felt by almost all surgeons to be a very important indication for PT gross obesity, prolonged pre-operative immobility and active malignancy were thought to be very important factors by approximately one-half of the surgeons. The presence of a major bleeding diathesis or active peptic ulcer was cited as a contraindication to PT by more than two-thirds of all surgeons. Fear of bleeding complications and the rarity of thromboembolic complications were cited as reasons for limited use of PT by about one-third of surgeons. The results suggest that most surgeons usually rely on non-pharmacological methods of thromboprophylaxis, particularly for NOFF patients.(ABSTRACT TRUNCATED AT 250 WORDS)
Publisher: Springer Science and Business Media LLC
Date: 2008
Publisher: Wiley
Date: 11-12-2007
DOI: 10.1111/J.1526-4610.2007.00947.X
Abstract: A prospective subgroup analysis of the TAME (Treat A Migraine Early) studies examined the efficacy of rizatriptan in patients treating a menstrual migraine attack. Both TAME studies were randomized, placebo-controlled, and double-blind. Adults with migraine were assigned (2:1) to either rizatriptan 10-mg tablet or placebo. Patients were instructed to treat within 1 hour of migraine onset and when the pain was mild. The primary endpoint was 2-hour pain freedom. The diagnosis of menstrual migraine was established according to the revised 2004 International Headache Society (IHS) diagnostic criteria. Data from both studies were pooled for logistic regression analyses. A test for interaction was performed to compare rates of 2-hour pain freedom between patients treating a menstrual and non-menstrual attack. A total of 94 patients (63 in the rizatriptan group and 31 in the placebo group) met IHS criteria for menstrual migraine and treated a menstrual attack. The percentage of patients reporting 2-hour pain freedom was significantly greater for rizatriptan than for placebo (63.5% vs 29.0% odds ratio = 4.5 95% confidence interval: 1.7, 11.9 P = .002) in those treating a menstrual attack. In those treating with rizatriptan, the percentage of patients with 2-hour pain freedom did not statistically differ between those treating a menstrual or non-menstrual migraine attack (63.5% vs 57.5% P = .454). Rizatriptan 10 mg was effective for the treatment of menstrual migraine in an early intervention model, as measured by 2-hour pain freedom. Rates of 2-hour pain freedom were comparable for patients treating menstrual and non-menstrual migraine attacks with rizatriptan.
Publisher: BMJ
Date: 08-2005
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: JMIR Publications Inc.
Date: 09-03-2023
DOI: 10.2196/43675
Abstract: Even modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. Our aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. A 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. A total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI −331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI −1083 to 1347) mg for urinary potassium excretion, −0.66 (95% CI −3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI −21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. In this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19–related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. Australian New Zealand Clinical Trials Registry ACTRN12619000352101 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471
Publisher: BMJ
Date: 27-05-2014
DOI: 10.1136/BMJ.G3318
Abstract: To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care. Open label randomised control trial: IMPACT (IMProving Adherence using Combination Therapy). 54 general practices in the Auckland and Waikato regions of New Zealand, July 2010 to August 2013. 513 adults (including 257 indigenous Māori) at high risk of cardiovascular disease (established cardiovascular disease or five year risk ≥ 15%) who were recommended for treatment with antiplatelet, statin, and two or more blood pressure lowering drugs. 497 (97%) completed 12 months' follow-up. Participants were randomised to continued usual care or to fixed dose combination treatment (with two versions available: aspirin 75 mg, simvastatin 40 mg, and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg). All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists. Primary outcomes were self reported adherence to recommended drugs (antiplatelet, statin, and two or more blood pressure lowering agents) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months. Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months (81% v 46% relative risk 1.75, 95% confidence interval 1.52 to 2.03, P<0.001 number needed to treat 2.9, 95% confidence interval 2.3 to 3.7). Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group: for antiplatelet treatment it was 93% fixed dose combination v 83% usual care (P<0.001), for statin 94% v 89% (P=0.06), for combination blood pressure lowering 89% v 59% (P<0.001), and for any blood pressure lowering 96% v 91% (P=0.02). Self reported adherence was highly concordant with dispensing data (dispensing of all four recommended drugs 79% fixed dose combination v 47% usual care, relative risk 1.67, 95% confidence interval 1.44 to 1.93, P<0.001). There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months: the difference in systolic blood pressure was -2.2 mm Hg (-4.5 v -2.3, 95% confidence interval -5.6 to 1.2, P=0.21), in diastolic blood pressure -1.2 mm Hg (-2.1 v -0.9, -3.2 to 0.8, P=0.22) and in low density lipoprotein cholesterol -0.05 mmol/L (-0.20 v -0.15, -0.17 to 0.08, P=0.46). The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups (fixed dose combination 16 v usual care 18 (P=0.73), 99 v 93 (P=0.56), respectively). Fixed dose combination treatment was discontinued in 94 participants (37%). The most commonly reported reason for discontinuation was a side effect (54/75, 72%). Overall, 89% (227/256) of fixed dose combination participants' general practitioners completed a post-trial survey, and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment (206/227, 91%), blood pressure control (180/220, 82%), cholesterol control (170/218, 78%), tolerability (181/223, 81%), and prescribing according to local guidelines (185/219, 84%). When participants were asked at 12 months how easy they found taking their prescribed drugs, most responded very easy or easy (224/246, 91% fixed dose combination v 212/246, 86% usual care, P=0.09). At 12 months the change in other lipid fractions, difference in EuroQol-5D, and difference in barriers to adherence did not differ significantly between the treatment groups. Among this well treated primary care population, fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance. Acceptability was high for both general practitioners and patients, although the discontinuation rate was high. Australian New Zealand Clinical Trial Registry ACTRN12606000067572.
Publisher: Informa UK Limited
Date: 2004
DOI: 10.1080/08037050410029605
Abstract: Analyses of the risks of stroke were conducted for subjects with and without diabetes, participating in a randomized, double-blind, placebo-controlled trial of a perindopril-based blood pressure lowering regimen in 6105 people with prior stroke or transient ischaemic attack (TIA), followed for a median of 3.9 years. Seven hundred and sixty-one patients had diabetes at baseline. Diabetes increased the risk of recurrent stroke by 35% (95% CI 10-65%) principally through an effect on ischaemic stroke (1.53, 95% CI 1.23-1.90). Active treatment reduced blood pressure by 9.5/4.6 mmHg in patients with diabetes and by 8.9/3.9 mmHg in patients without diabetes. The proportional risk reductions achieved for stroke in patients with diabetes, 38% (95% CI 8-58%), and patients without diabetes, 28% (95% CI 16-39%), were not significantly different (p homogeneity = 0.5). The absolute reduction in the risk of recurrent stroke in the patients with diabetes was equivalent to one stroke avoided among every 16 (95% CI 9-111) patients treated for 5 years. Diabetes is an important risk factor for stroke in patients with established cerebrovascular disease. Treatment with the ACE inhibitor perindopril with discretionary use of the diuretic indapamide produced reductions in the risk of recurrent stroke in patients with diabetes that were at least as great as those achieved in patients without diabetes.
Publisher: SAGE Publications
Date: 02-2019
Publisher: Elsevier BV
Date: 2023
DOI: 10.2139/SSRN.4326806
Publisher: Wiley
Date: 09-2008
DOI: 10.1111/J.1526-4610.2008.01093.X
Abstract: To examine the efficacy of rizatriptan for the treatment of pure menstrual migraine (PMM). In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored rizatriptan compared with placebo in patients with either PMM or MRM. Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.
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: Wiley
Date: 07-2023
DOI: 10.1111/IMJ.16159
Abstract: With the increasing costs of drug development, repurposing of low‐cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off‐patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide ex les of successful repurposing strategies.
Publisher: WHO Press
Date: 05-04-2016
Publisher: Elsevier BV
Date: 03-2014
Publisher: SAGE Publications
Date: 02-2017
Abstract: Understanding patients’ perspective towards HIV screening in Malaysia is pivotal to explore challenges faced by these in iduals. This would be beneficial for developing local plans to improve the health-seeking behaviours among population at risk of HIV/AIDS. A qualitative research methodology was adopted to explore HIV/AIDS patients’ views about disease screening. A semi-structured interview guide was used for in-depth patient interviews. All interviews were audio-recorded and were subjected to a standard content analysis framework for data analysis. Most patients were positive about screening and the value of knowing about their status early. However, fear of social stigma, discrimination, lack of support system and lack of public understanding were identified as major concerns affecting their willingness to be screened. They were concerned about mandatory screening being implemented without improvement in support system and public education. Reluctance to seek HIV screening is an important factor contributing to transmission in developing countries. In the Malaysian context, efforts should be made to strengthen screening strategies especially in the most-at-risk populations to monitor the epidemic and target prevention strategies. In a multicultural context, HIV preventive strategies must include disease awareness, including measure to tackle barriers towards screening.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2012
DOI: 10.1161/STROKEAHA.112.651448
Abstract: Observational studies demonstrate strong associations between blood pressure and bleeding complications of antithrombotic therapy. The objective was to determine whether blood pressure lowering reduces risks of bleeding in patients on antithrombotic therapy. This is a subsidiary analysis of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) trial, a randomized, placebo-controlled trial. A total of 6105 patients with cerebrovascular disease were randomly assigned to either active treatment (perindopril±indapamide) or placebo(s). The outcomes were intracranial and extracranial bleeding. There were 4876 (80%) patients on antithrombotic therapy at baseline. Over a mean follow-up of 3.9 years, 119 intracranial and 123 extracranial bleeding events were observed. Among patients with and without antithrombotic therapy, active treatment lowered blood pressure by 8.9/4.0 and 9.3/3.8 mm Hg and reduced the risks of intracranial bleeding by 46% (95% CI, 7%–69%) and 70% (39%–85%), respectively. However, active treatment did not reduce the risks of extracranial bleeding significantly in either group. Among patients on antithrombotic therapy, the lowest risk of intracranial bleeding was observed in participants with the lowest follow-up systolic blood pressure levels (median, 113 mm Hg). Blood pressure lowering provides protection against intracranial bleeding among patients with cerebrovascular disease including those receiving antithrombotic therapy. This trial was not registered because patients were enrolled before July 1, 2005.
Publisher: Springer Science and Business Media LLC
Date: 29-01-2012
Publisher: SAGE Publications
Date: 15-03-2018
Abstract: Ketamine research in depression has mostly used intravenous, weight-based approaches, which are difficult to translate clinically. Intranasal (IN) ketamine is a promising alternative but no controlled data has been published on the feasibility, safety and potential efficacy of repeated IN ketamine treatments. This randomised, double-blind, placebo-controlled pilot study compared a 4-week course of eight treatments of 100 mg ketamine or 4.5 mg midazolam. Each treatment was given as 10 separate IN sprays, self-administered 5 min apart. The study was stopped early due to poor tolerability after five treatment-resistant depressed participants were included. Feasibility, safety (acute and cumulative), cognitive and efficacy outcomes were assessed. Plasma ketamine and norketamine concentrations were assayed after the first treatment. Significant acute cardiovascular, psychotomimetic and neurological side effects occurred at doses 100 mg ketamine. No participants were able to self-administer all 10 ketamine sprays due to incoordination treatment time occasionally had to be extended ( min) due to acute side effects. No hepatic, cognitive or urinary changes were observed after the treatment course in either group. There was an approximately two-fold variation in ketamine and norketamine plasma concentrations between ketamine participants. At course end, one participant had remitted in each of the ketamine and midazolam groups. IN ketamine, with the drug formulation and delivery device used, was not a useful treatment approach in this study. Absorption was variable between in iduals and acute tolerability was poor, requiring prolonged treatment administration time in some in iduals. The drug formulation, the delivery device, the insufflation technique and in idual patient factors play an important role in tolerability and efficacy when using IN ketamine for TRD.
Publisher: AMPCo
Date: 02-2017
DOI: 10.5694/MJA16.01057
Publisher: JMIR Publications Inc.
Date: 15-11-2016
DOI: 10.2196/MHEALTH.5996
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: BMJ
Date: 24-02-2017
DOI: 10.1136/HEARTJNL-2016-310195
Abstract: To estimate the cost-effectiveness of Tobacco, Exercise and Diet Messages (TEXT ME), a text message-based intervention that provides advice, motivation, information and support to improve health-related behaviours. A lifetime Markov model was used to estimate major vascular events (myocardial infarctions and strokes) avoided, quality-adjusted life years (QALYs) gained, costs to the health system and the incremental cost per QALY gained. The model was informed by data from a randomised controlled trial of TEXT ME, with evidence from systematic reviews and meta-analyses used to estimate the effects of changes in risk factors on the risk of major vascular events. Expected costs and health outcomes were estimated with uncertainty surrounding these characterised using probabilistic sensitivity analysis and a number of scenario analyses. For a target population of 50 000 patients with documented coronary heart disease, the intervention is expected to lead to 563 fewer myocardial infarctions, 361 fewer strokes and 1143 additional QALYs. TEXT ME is expected to lead to an overall saving of $10.56 million for the health system over the patients' lifetimes. The intervention can therefore be considered cost-saving and health-improving. Neither parameter nor structural uncertainty had a significant impact on the conclusion that TEXT ME is cost-effective. The provision of TEXT ME is predicted to lead to better health outcomes and an overall saving in costs for the health system. anzctr.org.au identifier: ACTRN12611000161921.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2004
DOI: 10.1097/00004872-200403000-00030
Abstract: To assess the consistency of the benefits of blood pressure lowering on secondary stroke risk by age, sex and geographic region of recruitment. Randomized, placebo-controlled trial. Participants were randomized to the angiotensin-converting enzyme (ACE) inhibitor perindopril (plus the diuretic indapamide if not indicated or contraindicated) or to placebo(s) over a mean follow-up of 3.9 years. Main analyses used Cox proportional hazards models on an intention-to-treat basis. Subgroup results were standardized for the proportion (42%) taking single-drug therapy. A total of 172 centres in Asia, Australia, New Zealand and Europe. Patients (n = 6105) with a history of stroke or transient ischaemic attack, of whom 50% were aged over 65 years at baseline, 30% were women and 39% were from Asia. Stroke, coronary heart disease and major vascular events. Overall, treatment reduced stroke by 28% [95% confidence interval (CI) 17-38%] and major vascular events by 26% (16-44%), with separately significant reductions across subgroups defined by age ( or = 65 years), sex and region (Asia or not). Treatment was safe and well tolerated, and the absolute benefits were large 5 years' treatment would be expected to avert at least one major vascular event among every 20 patients in all age, sex and region subgroups. There was some evidence of particularly large benefits among younger participants and those from Asia. Blood pressure lowering reduces secondary stroke risk, with large absolute benefits across groups defined by age, sex and geographic region.
Publisher: 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: Wiley
Date: 09-07-2010
DOI: 10.1111/J.1360-0443.2010.02989.X
Abstract: To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months. Pragmatic randomized controlled trial. New Zealand. Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: -3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups. In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.
Publisher: BMJ
Date: 12-2016
Publisher: Wiley
Date: 12-10-2010
DOI: 10.1111/J.1526-4610.2010.01771.X
Abstract: To examine total migraine freedom (TMF), defined as pain freedom and absence of associated symptoms, using rizatriptan clinical trial data and to explore advantages of TMF as a single primary composite efficacy endpoint. The FDA has set a higher regulatory hurdle for registration of new migraine agents requiring both pain freedom (or relief) and absence of each associated symptom (phonophobia, photophobia, and nausea). Twelve studies representing phase III + efficacy/safety studies of rizatriptan 10 mg in adults treating migraine were included in the meta-analysis. The percentage of patients achieving TMF at 2 hours by study and combined by treatment group was summarized by treatment paradigm (early/mild pain, moderate/severe, menstrual migraine). To demonstrate the impact of the strict migraine regulatory hurdle on clinical trial design and to compare it to TMF, simulation via bootstrap s ling was used. Odds ratios (rizatriptan vs placebo, all P < .001) for TMF were 6.2 (95% CI: [4.9, 7.7]) for moderate/severe, 2.7 (95% CI: [1.8, 4.0]) for menstrual, and 3.1 (95% CI: [2.4, 4.0]) for early/mild. Most with moderate/severe migraine reported photophobia and/or phonophobia at baseline, but only half had nausea. Simulation results showed a substantial loss of power analyzing absence of pain and each symptom compared with the composite TMF endpoint across all treatment paradigms. Rizatriptan 10 mg was superior to placebo in achieving TMF at 2 hours post-dose across all treatment paradigms. Given that the majority of patients with migraine do not exhibit all 3 associated symptoms, the TMF endpoint has significant advantages vs establishing efficacy on pain and each symptom in idually.
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: Oxford University Press (OUP)
Date: 27-04-2007
DOI: 10.1093/IJE/DYM067
Abstract: Recent epidemiological evidence has shown increased rates of cardiovascular mortality and associated risk factors in those born small. However, scarce information exists concerning cardiovascular risk factors in adulthood following pre-term birth, or distinguishing the relative contributions of length of gestation and fetal growth to small size at birth. Prospective follow-up of 458 30-year-olds whose mothers took part in a randomized controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (147 born at term, 311 born pre-term). Follow-up assessments included anthropometry, blood pressure, blood lipids, early morning cortisol levels and 75 g oral glucose tolerance test. Gestational age at birth, pre-term birth, and birth weight z-score were not associated with serum cholesterol, triglyceride or cortisol at age 30 (P > 0.1 for all). However, pre-term birth was associated with increased systolic blood pressure (3.5 mmHg, 95% CI 0.9-6.1 mmHg, P = 0.009) and insulin resistance at age 30 [Log (Insulin area under the curve) = 0.17, 95% CI 0.05-0.28, P = 0.006]. Low gestational age at birth was also associated with these outcomes, whereas birth weight, adjusted for gestational age, was not. Adults who were born moderately pre-term have increased blood pressure and insulin resistance at 30 years of age. Pre-term birth rather than poor fetal growth is the major determinant of this association. As both the incidence of pre-term birth and survival amongst those born pre-term are increasing, this group may contribute an increasing proportion to overall cardiovascular disease burden.
Publisher: Public Library of Science (PLoS)
Date: 21-08-2012
Publisher: Elsevier BV
Date: 03-2009
Publisher: Elsevier BV
Date: 09-2001
Publisher: FapUNIFESP (SciELO)
Date: 2010
Publisher: Elsevier BV
Date: 2005
Publisher: Oxford University Press (OUP)
Date: 28-12-2007
DOI: 10.1002/BJS.6059
Abstract: The efficacy of honey as a treatment for venous ulcers has not been evaluated, despite widespread interest. This trial aimed to evaluate the safety and effectiveness of honey as a dressing for venous ulcers. This community-based open-label randomized trial allocated people with a venous ulcer to calcium alginate dressings impregnated with manuka honey or usual care. All participants received compression bandaging. The primary outcome was the proportion of ulcers healed after 12 weeks. Secondary outcomes were: time to healing, change in ulcer area, incidence of infection, costs per healed ulcer, adverse events and quality of life. Analysis was by intention to treat. Of 368 participants, 187 were randomized to honey and 181 to usual care. At 12 weeks, 104 ulcers (55·6 per cent) in the honey-treated group and 90 (49·7 per cent) in the usual care group had healed (absolute increase 5·9 (95 per cent confidence interval (c.i.) − 4·3 to 15·7) per cent P = 0·258). Treatment with honey was probably more expensive and associated with more adverse events (relative risk 1·3 (95 per cent c.i. 1·1 to 1·6) P = 0·013). There were no significant differences between the groups for other outcomes. Honey-impregnated dressings did not significantly improve venous ulcer healing at 12 weeks compared with usual care. Registration number: ISRCTN 06161544 (www.controlled-trials.com).
Publisher: Wiley
Date: 02-2010
Publisher: Elsevier BV
Date: 10-2002
DOI: 10.1111/J.1467-842X.2002.TB00346.X
Abstract: To determine whether capture-recapture analysis provides more reliable estimates of the cumulative incidence and prevalence of leg ulcers in Auckland, New Zealand. A population-based, cross-sectional study was conducted in the Central and North Auckland health districts of New Zealand in 1998. Cases were identified through health professional referral and by self-notification. All ages and ulcer types were investigated. Both traditional and capture-recapture methods of analysis were used to estimate the cumulative incidence and prevalence of leg ulcers in the study population. Four hundred and twenty-six people with current leg ulcers were identified during the 12-month study period. Using traditional methods of analysis, the annual cumulative incidence rate of leg ulcers in Auckland was 32 per 100,000, with a point prevalence of 39 per 100,000 and a period prevalence of 79 per 100,000 per year. Results from capture-recapture analysis, however, suggest an annual cumulative incidence rate of 252 per 100,000, with a point prevalence of 248 per 100,000 and a period prevalence of 530 per 100,000 per year. The traditional method of calculating cumulative incidence and prevalence clearly under-estimates the frequency of leg ulcers in the Auckland region. Capture-recapture analysis provides a more reliable estimate of disease frequency, since cases that remain unidentified in the population are considered.
Publisher: Elsevier BV
Date: 05-2015
Publisher: BMJ
Date: 03-2018
DOI: 10.1136/BMJOPEN-2016-013063
Abstract: The ‘Use of a Multi-drug Pill in Reducing cardiovascular Events’ (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strategy for CVD prevention within the NHS using UMPIRE trial and other relevant data. This paper describes the design of a modelled economic evaluation of the impact of increased adherence to the polypill versus usual care among the UK UMPIRE participants. As recommended by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modelling guidelines, a review of published CVD models was undertaken to identify the most appropriate modelling approach and structure. The review was carried out in the electronic databases, MEDLINE and EMBASE. 40 CVD models were identified from 57 studies, the majority of economic models were health state transition cohort models and in idual-level simulation models. The findings were discussed with clinical experts to confirm the approach and structure. An in idual simulation approach was identified as the most suitable method to capture the heterogeneity in the population at CVD risk. RUPEE-NHS will use UMPIRE trial data on adherence to estimate the long-term cost-effectiveness of the polypill strategy. The evaluation findings will be presented in open-access scientific and healthcare policy journals and at national and international conferences. We will also present findings to NHS policy makers and pharmaceutical companies.
Publisher: SAGE Publications
Date: 08-2008
Publisher: Elsevier BV
Date: 03-2005
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2019
DOI: 10.1161/HYPERTENSIONAHA.118.12060
Abstract: Discontinuation of angiotensin-converting enzyme (ACE) inhibitor is recommended if patients experience ≥30% acute increase in serum creatinine after starting this therapy. However, the long-term effects of its continuation or discontinuation on major clinical outcomes after increases in serum creatinine are unclear. In the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation), 11 140 diabetes mellitus patients were randomly assigned to perindopril-indapamide or placebo after a 6-week active run-in period. The current study included 11 066 participants with 2 serum creatinine measurements recorded before and during the active run-in period (3 weeks apart). Acute increase in creatinine was determined using these 2 measurements and classified into 4 groups: increases in serum creatinine of %, 10% to 19%, 20% to 29%, and ≥30%. The primary study outcome was the composite of major macrovascular events, new or worsening nephropathy, and all-cause mortality. An acute increase in serum creatinine was associated with an elevated risk of the primary outcome ( P for trend .001). The hazard ratios were 1.11 (95% CI, 0.97–1.28) for those with an increase of 10% to 19%, 1.34 (1.07–1.66) for 20% to 29%, and 1.44 (1.15–1.81) for ≥30%, compared with %. However, there was no evidence of heterogeneity in the benefit of randomized treatment effects on the outcome across subgroups defined by acute serum creatinine increase ( P for heterogeneity=0.94). Acute increases in serum creatinine after starting perindopril-indapamide were associated with greater risks of subsequent major clinical outcomes. However, the continuation of angiotensin-converting enzyme inhibitor-based therapy reduced the long-term risk of major clinical outcomes, irrespective of acute increase in creatinine. URL: www.clinicaltrials.gov . Unique identifier: NCT00145925.
Publisher: American Diabetes Association
Date: 27-10-2018
DOI: 10.2337/DC17-1467
Abstract: To assess the association between 2-year changes in urine albumin-to-creatinine ratio (UACR) and the risk of clinical outcomes in type 2 diabetes. We analyzed data from 8,766 participants in the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation Post-Trial Observational Study (ADVANCE-ON). Change in UACR was calculated from UACR measurements 2 years apart, classified into three groups: decrease in UACR of ≥30%, minor change, and increase in UACR of ≥30%. By analyzing changes from baseline UACR groups, categorized into thirds, we repeated these analyses accounting for regression to the mean (RtM). The primary outcome was the composite of major macrovascular events, renal events, and all-cause mortality secondary outcomes were these components. Cox regression models were used to estimate hazard ratios (HRs). Over a median follow-up of 7.7 years, 2,191 primary outcomes were observed. Increases in UACR over 2 years independently predicted a greater risk of the primary outcome (HR for ≥30% UACR increase vs. minor change: 1.26 95% CI 1.13-1.41), whereas a decrease in UACR was not significantly associated with lower risk (HR 0.93 95% CI 0.83-1.04). However, after allowing for RtM, the effect of "real" decrease in UACR on the primary outcome was found to be significant (HR 0.84 95% CI 0.75-0.94), whereas the estimated effect on an increase was unchanged. Changes in UACR predicted changes in the risk of major clinical outcomes and mortality in type 2 diabetes, supporting the prognostic utility of monitoring albuminuria change over time.
Publisher: Springer Science and Business Media LLC
Date: 06-07-2021
DOI: 10.1007/S00125-021-05491-7
Abstract: Type 2 diabetes increases the risk of cardiovascular and renal complications, but early risk prediction could lead to timely intervention and better outcomes. Genetic information can be used to enable early detection of risk. We developed a multi-polygenic risk score (multiPRS) that combines ten weighted PRSs (10 wPRS) composed of 598 SNPs associated with main risk factors and outcomes of type 2 diabetes, derived from summary statistics data of genome-wide association studies. The 10 wPRS, first principal component of ethnicity, sex, age at onset and diabetes duration were included into one logistic regression model to predict micro- and macrovascular outcomes in 4098 participants in the ADVANCE study and 17,604 in iduals with type 2 diabetes in the UK Biobank study. The model showed a similar predictive performance for cardiovascular and renal complications in different cohorts. It identified the top 30% of ADVANCE participants with a mean of 3.1-fold increased risk of major micro- and macrovascular events ( p = 6.3 × 10 −21 and p = 9.6 × 10 −31 , respectively) and a 4.4-fold ( p = 6.8 × 10 −33 ) higher risk of cardiovascular death. While in ADVANCE overall, combined intensive blood pressure and glucose control decreased cardiovascular death by 24%, the model identified a high-risk group in whom it decreased the mortality rate by 47%, and a low-risk group in whom it had no discernible effect. High-risk in iduals had the greatest absolute risk reduction with a number needed to treat of 12 to prevent one cardiovascular death over 5 years. This novel multiPRS model stratified in iduals with type 2 diabetes according to risk of complications and helped to target earlier those who would receive greater benefit from intensive therapy.
Publisher: Wiley
Date: 02-05-2016
DOI: 10.5694/MJA16.00190
Publisher: Oxford University PressOxford
Date: 30-06-2009
DOI: 10.1093/ACPROF:OSO/9780198525738.003.0011
Abstract: This chapter presents estimates of blood pressure distributions by age, sex, and world region to estimate the burden of coronary heart disease (CHD) attributable to raised blood pressure worldwide in the year 2000. It summarizes work produced for the WHO Global Burden of Disease 2000 study and the World Health Report 2002, which included estimates of the burden of disease attributable to a variety of risk factors including blood pressure.
Publisher: Elsevier BV
Date: 08-2010
DOI: 10.1016/J.JCONREL.2010.03.023
Abstract: This paper reviews the application of intrinsically conducting polymers (ICPs) in drug delivery. ICPs are organic polymers with electrical, magnetic and optical properties usually associated with metals, whilst retaining the advantageous mechanical properties and ease of processing usually associated with polymers. Due to the inherent properties of these unique materials, electrical stimulation can be used to alter the redox state of ICPs, which in turn can modify the release rate of drug. The controlled release of drugs from ICPs has been reported in the literature since the 1980s. Following continued development, clinical applications of ICP-based drug delivery systems (DDS) have been reported recently. The next generation of controlled release technologies could utilise the biosensing properties of ICPs combined with their drug delivering abilities to develop an intelligent drug delivery system from a single material where the release rate of drug self adjusts in response to a sensed change in local body environment. This article provides an overview of ICP synthesis and properties relevant to their use as DDS, including biodegradability and biocompatibility, followed by literature on ICP-based DDS examining different methods of drug incorporation and release. The pharmaceutical applications of these systems have also been discussed. It is concluded that ICPs hold great promise in drug delivering implants where the dose can be adjusted through application of external stimulus, thus optimising benefit to side effect ratio while simultaneously ensuring patient adherence.
Publisher: Elsevier BV
Date: 11-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2022
DOI: 10.1161/CIRCOUTCOMES.121.008552
Abstract: Mendelian randomization studies use genetic variants as natural experiments to provide evidence about causal relations between modifiable risk factors and disease. Recent Mendelian randomization studies suggest each mmol/L reduction in low-density lipoprotein cholesterol (LDL-C) sustained over a lifetime can reduce the risk of cardiovascular disease by more than half. However, these findings have not been replicated in randomized clinical trials, and the effect of treatment duration on the magnitude of risk reduction remains uncertain. The aim of this article was to evaluate the relationship between lipid-lowering drug exposure time and relative risk reduction of major cardiovascular events in randomized clinical trials. We conducted a systematic review and meta-analysis of randomized clinical trials of statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitors that report LDL-C levels and effect sizes for each year of follow-up. The primary end point was major vascular events, defined as the composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization. Hazard ratios during each year of follow-up were meta-analyzed using random-effects models. A total of 21 trials with 184 012 patients and an average mean follow-up of 4.4 years were included. Meta-regression showed there was greater relative risk reduction in major vascular events with increasing duration of treatment ( P .001). For ex le, each mmol/L LDL-C lowered was associated with a relative risk reduction in major vascular events of 12% (95% CI, 8%–16%) for year 1, 20% (95% CI, 16%–24%) for year 3, 23% (95% CI, 18%–27%) for year 5, and 29% (95% CI, 14%–42%) for year 7. The benefits of LDL-C lowering do not seem to be fixed but increase steadily with longer durations of treatment. The results from short-term randomized trials are compatible with the very strong associations between LDL-C and cardiovascular events seen in Mendelian randomization studies.
Publisher: Wiley
Date: 02-2010
Publisher: Springer Science and Business Media LLC
Date: 09-09-2012
Publisher: JMIR Publications Inc.
Date: 25-11-2008
DOI: 10.2196/JMIR.1007
Publisher: Oxford University PressOxford
Date: 30-06-2005
DOI: 10.1093/ACPROF:OSO/9780198525738.003.0012
Abstract: This chapter discusses the role of lipids and cholesterol in coronary heart disease (CHD). The high levels of serum cholesterol found in Western populations are a major cause of the high mortality from CHD. Realistic dietary change in a community can lower serum cholesterol by 0.6 mmol/l (10%) and reduce heart disease mortality by approximately 25% among middle-aged in iduals. Cholesterol-lowering drugs (statins) can lower cholesterol by 1.8 mmol/l (30%), and reduce the risk of heart disease death by approximately 60% from the third year onwards. Statins are inexpensive and safe, and their widespread use should be encouraged.
Publisher: AMPCo
Date: 2017
DOI: 10.5694/MJA16.00988
Publisher: Massachusetts Medical Society
Date: 09-06-2016
DOI: 10.1056/NEJMC1602668
Publisher: Springer Science and Business Media LLC
Date: 15-02-2023
Publisher: John Wiley & Sons, Ltd
Date: 14-11-2012
Publisher: Wiley
Date: 10-04-2016
Publisher: Cambridge University Press (CUP)
Date: 06-2005
DOI: 10.1079/PHN2004694
Abstract: To estimate the burden of disease due to selected nutrition-related risk factors (high total blood cholesterol, high systolic blood pressure, high body mass index (BMI) and inadequate vegetable and fruit intake) in 1997, as well as the burden that could potentially be avoided in 2011 if small, favourable changes in the current risk factor distribution were to occur. Data on risk factor levels, disease burden and risk associations were combined using comparative risk assessment methodology, a systematic approach to estimating both attributable and avoidable burden of disease. Disease outcomes assessed varied according to risk factor and included ischaemic heart disease, stroke, type 2 diabetes mellitus and selected cancers. New Zealand. Approximately 4500 deaths (17% of all deaths) in 1997 were attributable to high cholesterol, 3500 (13%) to high blood pressure, 3000 (11%) to high BMI and 1500 (6%) to inadequate vegetable and fruit intake. Taking prevalence overlap into account, these risk factors were estimated jointly to contribute to approximately 11 000 (40%) deaths annually in New Zealand. Approximately 300 deaths due to each risk factor could potentially be avoided in 2011 if modest changes were made to each risk factor distribution. High cholesterol, blood pressure and BMI, as well as inadequate vegetable and fruit intake, are major modifiable causes of death in New Zealand. Small changes in the population distribution of these risk factors could have a major impact on population health within a decade.
Publisher: Wiley
Date: 22-10-2019
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: BMJ
Date: 10-08-2023
DOI: 10.1136/BMJ.P1847
Publisher: Elsevier BV
Date: 07-2003
DOI: 10.1016/S0140-6736(03)13968-2
Abstract: Estimates of the disease burden due to multiple risk factors can show the potential gain from combined preventive measures. But few such investigations have been attempted, and none on a global scale. Our aim was to estimate the potential health benefits from removal of multiple major risk factors. We assessed the burden of disease and injury attributable to the joint effects of 20 selected leading risk factors in 14 epidemiological subregions of the world. We estimated population attributable fractions, defined as the proportional reduction in disease or mortality that would occur if exposure to a risk factor were reduced to an alternative level, from data for risk factor prevalence and hazard size. For every disease, we estimated joint population attributable fractions, for multiple risk factors, by age and sex, from the direct contributions of in idual risk factors. To obtain the direct hazards, we reviewed publications and re-analysed cohort data to account for that part of hazard that is mediated through other risks. Globally, an estimated 47% of premature deaths and 39% of total disease burden in 2000 resulted from the joint effects of the risk factors considered. These risks caused a substantial proportion of important diseases, including diarrhoea (92%-94%), lower respiratory infections (55-62%), lung cancer (72%), chronic obstructive pulmonary disease (60%), ischaemic heart disease (83-89%), and stroke (70-76%). Removal of these risks would have increased global healthy life expectancy by 9.3 years (17%) ranging from 4.4 years (6%) in the developed countries of the western Pacific to 16.1 years (43%) in parts of sub-Saharan Africa. Removal of major risk factors would not only increase healthy life expectancy in every region, but also reduce some of the differences between regions. The potential for disease prevention and health gain from tackling major known risks simultaneously would be substantial.
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: Elsevier BV
Date: 05-2005
Publisher: Elsevier BV
Date: 11-2023
Publisher: Wiley
Date: 03-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2019
Publisher: Elsevier BV
Date: 06-2016
Publisher: BMJ
Date: 10-2019
DOI: 10.1136/OPENHRT-2019-001017
Abstract: A variety of small mobile phone text-messaging interventions have indicated improvement in risk factors for cardiovascular disease (CVD). Yet the extent of this improvement and whether it impacts multiple risk factors together is uncertain. We aimed to conduct a systematic review and in idual patient data (IPD) meta-analysis to investigate the effects of text-messaging interventions for CVD prevention. Electronic databases were searched to identify trials investigating a text-messaging intervention focusing on CVD prevention with the potential to modify at least two CVD risk factors in adults. The main outcome was blood pressure (BP). We conducted standard and IPD meta-analysis on pooled data. We accounted for clustering of patients within studies and the primary analysis used random-effects models. Sensitivity and subgroup analyses were performed. Nine trials were included in the systematic review involving 3779 participants and 5 (n=2612) contributed data to the IPD meta-analysis. Standard meta-analysis showed that the weighted mean differences are as follows: systolic blood pressure (SBP), −4.13 mm Hg (95% CI −11.07 to 2.81, p .0001) diastolic blood pressure (DBP), −1.11 mm Hg (−1.91 to −0.31, p=0.002) and body mass index (BMI), −0.32 (−0.49 to −0.16, p=0.000). In the IPD meta-analysis, the mean difference are as follows: SBP, −1.3 mm Hg (−5.4 to 2.7, p=0.5236) DBP, −0.8 mm Hg (−2.5 to 1.0, p=0.3912) and BMI, −0.2 (−0.8 to 0.4, p=0.5200) in the random-effects model. The impact on other risk factors is described, but there were insufficient data to conduct meta-analyses. Mobile phone text-messaging interventions have modest impacts on BP and BMI. Simultaneous but small impacts on multiple risk factors are likely to be clinically relevant and improve outcome, but there are currently insufficient data in pooled analyses to examine the extent to which simultaneous reduction in multiple risk factors occurs. CRD42016033236.
Publisher: Oxford University Press (OUP)
Date: 28-10-2008
DOI: 10.1093/HER/CYN057
Publisher: Elsevier BV
Date: 04-1990
Publisher: John Wiley & Sons, Ltd
Date: 07-10-2009
Publisher: Informa UK Limited
Date: 27-05-2016
Publisher: Elsevier BV
Date: 07-2018
Publisher: Elsevier BV
Date: 02-2015
Publisher: SAGE Publications
Date: 28-03-2008
Abstract: Background For clinical trials of interventions that could affect mortality or major morbidity, Data Monitoring Committees have an important role in safeguarding patient interests and enhancing trial integrity and credibility. In trials overseen by an independent DMC it is widely recognized that interim data should remain confidential to the DMC and to the statistical group preparing reports. However, we have found that the principle of confidentiality is not always followed in practice, particularly where the interim data include complete results on a short-term outcome measure. Purpose To discuss the reasoning and evidence supporting the principle of confidentiality of interim data with emphasis on the setting where the interim data include complete results on a short-term outcome. Methods We review the reasons why wider access to interim data can increase the risk of false positive or false negative conclusions and discuss the types of harm which can occur. We provide illustrations and insights from recent experiences and discuss the level of consensus in the research community. Results The arguments in favor of early release of interim data include the need to provide reliable data in a timely manner to patients and physicians, the potential to increase the enthusiasm of trial investigators, and to restore equipoise. However interim data, even where these include complete results on a short-term outcome measure, provide an unreliable and biased assessment of the overall benefit-to-risk profile of the trial treatments. Pre-judgment based on over-interpretation of such interim data can affect recruitment, treatment delivery, and follow-up, risking the ability of the trial to achieve its goals. Conclusions In order to preserve the integrity of a trial and safeguard the interests of patients, interim data, including complete data on short-term outcomes, should remain confidential to the DMC and the statistical group responsible for preparing interim reports until the trial has achieved its primary objectives. Clinical Trials 2008 5: 157—167. ctj.sagepub.com
Publisher: Public Library of Science (PLoS)
Date: 25-05-2011
Publisher: Oxford University Press (OUP)
Date: 28-07-2004
DOI: 10.1093/IJE/DYH163
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2019
Publisher: John Wiley & Sons, Ltd
Date: 08-10-2008
Publisher: Elsevier BV
Date: 05-2008
Publisher: JMIR Publications Inc.
Date: 19-10-2022
Abstract: ven modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. ur aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI −331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI −1083 to 1347) mg for urinary potassium excretion, −0.66 (95% CI −3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI −21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. n this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19–related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. ustralian New Zealand Clinical Trials Registry ACTRN12619000352101 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 17-11-2020
DOI: 10.1161/CIRC.142.SUPPL_3.13354
Abstract: Introduction: Cardiovascular disease (CVD) risk management is suboptimal in Australian primary healthcare. Following trials demonstrating efficacy of in idual components, we developed a complex intervention comprised primarily of electronic point-of-care decision support, availability of cardiovascular polypills and a pharmacy-based adherence program. We sought to determine whether this combined multifaceted intervention, compared with usual care, would improve control of CVD risk factors in the Australian primary care setting. Methods and Results: In a parallel-arm cluster randomized trial, 71 general practices were allocated 1:1 either to the intervention or usual care. The primary outcome was the proportion of patients at high CVD risk and not on optimal preventive treatments at baseline (“high-risk under-treated”) achieving both blood pressure (BP) and low density lipoprotein (LDL) cholesterol targets at study end (BP ≤140/90 mmHg, or ≤130/80 mmHg in people with diabetes or albuminuria LDL .0 mmol/L). All outcomes were evaluated using automated extracts from the electronic medical record. After a median period of 15 months follow-up, among 4477 high-risk under-treated patients in whom follow-up data were available, there was a negligible difference between randomized groups in the proportion achieving SBP and LDL cholesterol targets (19.6% vs. 20.1% RR 1.06 [95% CI: 0.85 to 1.32] p=0.59). There was also no major impact of the intervention on any pre-specified secondary outcomes, mostly relating to risk factor screening, preventive medication prescription and risk factor levels. Uptake of all components of the intervention was poor, with greatest use observed for the electronic decision support component (used at least once in 10.7% of high-risk under-treated patients) and minimal use of the other two interventions. Conclusions: Despite the proven efficacy of in idual components, this complex multifaceted intervention was poorly adopted and did not lead to relevant improvements in cardiovascular risk factor outcomes.
Publisher: BMJ
Date: 07-2001
DOI: 10.1136/EBM.6.4.124
Publisher: Public Library of Science (PLoS)
Date: 19-10-2004
Publisher: Oxford University Press (OUP)
Date: 22-10-2010
Abstract: Utility cycling provides substantial health, environmental and economic benefits. Despite a favourable trend in leisure-time cycling, cycling is infrequently used for everyday travel needs in New Zealand. This study investigated cyclists' attitudes toward environmental and policy measures that would encourage them to cycle more, particularly for a trip to work. A cross-sectional analysis was undertaken using baseline data obtained from the Taupo Bicycle Study, a web-based longitudinal study. The study population comprised 2469 cyclists, aged 16 years or over, who had enrolled in the 2006 Wattyl Lake Taupo Cycle Challenge. The majority (88%) reported the provision of bicycle lanes as an important factor that would encourage them to cycle more often, followed by bicycle paths (76%), better bicycle security (64%), reduced motor vehicle speed (55%) and bike friendly public transport (38%). Of those who reported travelling to work at least once a week (N = 2223), varying proportions reported shower facilities at work (61%), fewer difficult intersections (43%), rising fuel costs (41%), fewer car parks (27%), bike designed to commute (26%) and rising cost of car parking (25%) as important factors that would encourage them to cycle to work more often. There were important differences in these perceived influences defined by the participants' socio-demographic characteristics and current cycling habits.
Publisher: Oxford University Press (OUP)
Date: 07-01-2016
Publisher: Elsevier BV
Date: 11-2011
DOI: 10.1016/J.CCT.2011.07.006
Abstract: Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high. To assess whether a medication strategy using a fixed dose combination pill ('polypill') could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months. IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).
Publisher: Elsevier BV
Date: 07-2017
Publisher: American Medical Association (AMA)
Date: 2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2023
DOI: 10.1161/HYPERTENSIONAHA.122.20115
Abstract: The SSaSS (Salt Substitute and Stroke Study) recently reported definitive effects of a potassium-enriched salt on cardiovascular outcomes and death. Quantifying the amount of potassium-enriched salt used by trial participants is important for understanding the magnitude of the effect of potassium-enriched salt on risk reduction and how population-wide scale-up might be achieved. Baseline and annual 24-hour urine s les were collected from subgroups of participants in SSaSS throughout the 5-year follow-up. The mean difference in 24-hour potassium excretion between the 2 groups was used to estimate the quantity of potassium-enriched salt consumed in the intervention group. The corresponding projected difference in sodium intake between groups was calculated and compared with the observed difference. The potassium-enriched salt group, compared to the regular salt group, had a mean increase in 24-hour urinary potassium excretion of 0.80 g/d (95% CI, 0.71–0.90), which equates to consumption of 8.8 g/d (95% CI, 7.8–9.9) of potassium-enriched salt. Based on 8.8 g/d potassium-enriched salt consumption, the projected difference in 24-hour urinary sodium excretion was −0.79 g/d. This compares to an observed difference of −0.35 g/d (95% CI, −0.55 to −0.15) and suggests that 72% of baseline regular salt intake was replaced by potassium-enriched salt. The smaller than anticipated between-group difference in sodium excretion likely results from the joint use of regular salt and potassium-enriched salt in the intervention group. Our findings suggest that even an incomplete replacement of regular salt with potassium-enriched salt can deliver significant health gains. URL: www.clinicaltrials.gov Unique identifier: NCT02092090.
Publisher: BMJ
Date: 24-03-2009
Abstract: To conduct a pilot randomised controlled trial of mobile phone-based smoking cessation support intervention for the UK population. Randomised controlled trial (txt2stop). Community. 200 participants responding to radio, poster and leaflet-based promotions regarding the trial. The response rate for the outcome measures planned for the main trial. Participants' qualitative responses to open-ended questions about the intervention content. Secondary outcomes were the outcomes planned for the main trial including the point prevalence of self-reported smoking at 4 weeks and pooled effect estimate for the short-term results for the STOMP and txt2stop trials. The response rate at 4 weeks was 96% and at 6 months was 92%. The results at 4 weeks show a doubling of self-reported quitting relative risk (RR) 2.08 (95% CI 1.11 to 3.89), 26% vs 12%. The pooled effect estimate combining txt2stop and a previous New Zealand trial in the short term is RR 2.18 (95% CI 1.79 to 2.65). Mobile phone-based smoking cessation is an innovative means of delivering smoking cessation support, which doubles the self-reported quit rate in the short term. It could represent an important, but as yet largely unused, medium to deliver age-appropriate public health measures. The long-term effect of this mobile phone-based smoking cessation support will be established by a large randomised controlled trial currently in recruitment.
Publisher: American Diabetes Association
Date: 25-07-2016
DOI: 10.2337/DC16-0588
Abstract: Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis in type 2 diabetes, but the relationship between other vascular diseases and PAD has been poorly investigated. We examined the impact of previous microvascular and macrovascular disease on the risk of major PAD in patients with type 2 diabetes. We analyzed 10,624 patients with type 2 diabetes free from baseline major PAD in the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) clinical trial. The primary composite outcome was major PAD defined as PAD-induced death, peripheral revascularization, lower-limb utation, or chronic ulceration. The secondary end points were the PAD components considered separately. Major PAD occurred in 620 (5.8%) participants during 5 years of follow-up. Baseline microvascular and macrovascular disease were both associated with subsequent risk of major PAD after adjustment for age, sex, region of origin, and randomized treatments. However, only microvascular disease remained significantly associated with PAD after further adjustment for established risk factors. The highest risk was observed in participants with a history of macroalbuminuria (hazard ratio 1.91 [95% CI 1.38–2.64], P & 0.0001) and retinal photocoagulation therapy (1.60 [1.11–2.32], P = 0.01). Baseline microvascular disease was also associated with a higher risk of chronic lower-limb ulceration (2.07 [1.56–2.75], P & 0.0001) and utation (1.59 [1.15–2.22], P = 0.006), whereas baseline macrovascular disease was associated with a higher rate of angioplasty procedures (1.75 [1.13–2.73], P = 0.01). Microvascular disease, particularly macroalbuminuria and retinal photocoagulation therapy, strongly predicts major PAD in patients with type 2 diabetes, but macrovascular disease does not.
Publisher: 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: BMJ
Date: 04-02-2011
Abstract: Reducing health inequalities requires interventions that work as well, if not better, among disadvantaged populations. The aim of this study was to determine if the effects of price discounts and tailored nutrition education on supermarket food purchases (percentage energy from saturated fat and healthy foods purchased) vary by ethnicity, household income and education. A 2×2 factorial trial of 1104 New Zealand shoppers randomised to receive a 12.5% discount on healthier foods and/or tailored nutrition education (or no intervention) for 6 months. There was no overall association of price discounts or nutrition education with percentage energy from saturated fat, or nutrition education with healthy food purchasing. There was an association of price discounts with healthy food purchasing (0.79 kg/week increase 95% CI 0.43 to 1.16) that varied by ethnicity (p=0.04): European/other 1.02 kg/week (n=755 95% CI 0.60 to 1.43) Pacific 1.20 kg/week (n=101 95% CI 0.06 to 2.34) Māori -0.15 kg/week (n=248 95% CI -1.10 to 0.80). This association of price discounts with healthy food purchasing did not vary by household income or education. While a statistically significant variation by ethnicity in the effect of price discounts on food purchasing was found, the authors caution against a causal interpretation due to likely biases (eg, attrition) that differentially affected Māori and Pacific people. The study highlights the challenges in generating valid evidence by social groups for public health interventions. The null findings for tailored nutritional education across all social groups suggest that structural interventions (such as price) may be more effective.
Publisher: Oxford University Press (OUP)
Date: 25-08-2019
Publisher: Elsevier BV
Date: 11-2008
Publisher: Wiley
Date: 08-2007
DOI: 10.1111/J.1469-8749.2007.00597.X
Abstract: The aim of this study was to determine if preterm birth is associated with socioeconomic status (SES), psychological functioning, and health-related quality of life (HRQoL) in adulthood. We used prospective follow-up of 192 adult offspring of mothers who took part in a randomized controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (66 born at term [33 males, 33 females] 126 born preterm [66 males, 60 females]). Cognitive functioning was assessed using the Wechsler Abbreviated Scale of Intelligence. Working memory and attention was assessed using the Benton Visual Retention Test, the Paced Auditory Serial Addition Test, and the Brown Attention Deficit Disorder Scale. Psychiatric morbidity was assessed using the Beck Depression Inventory II, the State-Trait Anxiety Inventory, and the Schizotypy Traits Questionnaire. Handedness was assessed using the Edinburgh Handedness Inventory. HRQoL was assessed using the Short Form-36 Health Survey. Moderately preterm birth (median gestation 34wks, mean birthweight 1946g [SD 463g]) was not related to later marital status, educational attainment, SES, cognitive functioning, working memory, attention, or symptoms of anxiety or schizotypy at 31 years of age. Preterm birth was associated with fewer symptoms of depression and higher levels of satisfaction in three of the eight HRQoL domains measured (bodily pain, general health perception, and social functioning). Adults who were born moderately preterm have SES, psychological functioning, and HRQoL consistent with those who were born at term. This good long-term outcome cannot be extrapolated to those with early childhood disability or very low birthweights.
Publisher: BMJ
Date: 28-08-2008
DOI: 10.1136/BMJ.A1371
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: 14-10-2022
DOI: 10.1038/S41440-022-01051-7
Abstract: We investigated whether diabetes mellitus (DM) affects the efficacy of a low-dose triple combination pill and usual care among people with mild-moderate hypertension. TRIUMPH (TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension) was a randomised controlled open-label trial of patients requiring initiation or escalation of antihypertensive therapy. Patients were randomised to a once-daily low-dose triple combination polypill (telmisartan-20mg/amlodipine-2.5 mg/chlorthalidone-12.5 mg) or usual care. This analysis compared BP reduction in people with and without DM, both in the intervention and control groups over 24-week follow-up. Predicted efficacy of prescribed therapy was calculated (estimation methods of Law et al.). The trial randomised 700 patients (56 ± 11 yrs, 31% DM). There was no difference in the number of drugs prescribed or predicted efficacy of therapy between people with DM and without DM. However, the observed BP reduction from baseline to week 24 was lower in those with DM compared to non-diabetics in both the triple pill (25/11 vs 31/15 mmHg, p ≤ 0.01) and usual care (17/7 vs 22/11 mmHg, p ≤ 0.01) groups, and these differences remained after multivariable adjustment. DM was a negative predictor of change in BP (β-coefficient -0.08, p = 0.02). In conclusion, patients with DM experienced reduced efficacy of BP lowering therapies as compared to patients without DM, irrespective of the type of BP lowering therapy received.
Publisher: Elsevier BV
Date: 06-2006
DOI: 10.1111/J.1467-842X.2006.TB00866.X
Abstract: To estimate mortality attributable to higher-than-optimal blood cholesterol in New Zealand in 1997, and the mortality burden that could be potentially avoided in 2011 if modest reductions in mean population blood cholesterol concentrations were achieved. Comparative risk assessment methodology was used to estimate the attributable and avoidable mortality due to higher-than-optimal total blood cholesterol (> 3.8 mmol/L). Disease outcomes assessed were deaths from ischaemic heart disease (IHD) and ischaemic stroke. Overall, higher-than-optimal blood cholesterol contributed to 4,721 deaths in New Zealand in 1997 (17% of all deaths). This included 4,096 IHD deaths (64%) and 625 ischaemic stroke deaths (38%). Modest reductions in mean population blood cholesterol concentrations (e.g. 0.1 mmol/L) could potentially prevent 300 deaths (261 IHD and 39 ischaemic stroke) each year from 2011. Higher-than-optimal blood cholesterol concentrations are a leading cause of mortality in New Zealand. Modest reductions in blood cholesterol levels could have a major impact on population health within a decade.
Publisher: Elsevier BV
Date: 03-2016
Publisher: Springer Science and Business Media LLC
Date: 2007
Publisher: Georg Thieme Verlag KG
Date: 2002
DOI: 10.1055/S-2002-36765
Abstract: Overviews of randomized controlled trials and prospective observational studies provide the most reliable data on the association between blood pressure and coronary heart disease (CHD). The totality of evidence indicates a strong association between blood pressure and CHD, which is continuous down to levels of at least 115 mm Hg systolic. Overall, for those 60 to 69 years of age, a 10 mm Hg lower systolic blood pressure is associated with about one-fifth lower risk of a CHD event. The size and shape of this association is consistent across regions, for males and females, and for fatal events as well as nonfatal myocardial infarction. Trials comparing active treatment to placebo or no treatment have demonstrated that the benefits of blood pressure lowering with different classes of drugs (e.g., diuretics, beta-blockers, ACE inhibitors, calcium antagonists) are broadly similar, with approximately one-fifth reduction in CHD. ACE inhibitors achieve this with relatively modest blood pressure reductions, but the size of the reduction for calcium antagonists remains uncertain and appears somewhat less than expected from the blood pressure reduction. Trials confirm the expectation from cohort studies of benefits increasing with the amount of blood pressure lowering, and benefit accruing among those with average or even below average blood pressure. Observational data suggest that the proportional association is attenuated with age, but attenuation is less evident in trial data. However, in both cohort studies and clinical trials, CHD risk differences associated with a given blood pressure difference increase with age. The important points to emerge from this review are, first, that the relative benefits of blood pressure lowering for CHD prevention are likely to be consistent across a range of different populations. Second, there is likely to be considerable benefit with blood pressure lowering below "traditional" hypertension thresholds, especially in those with high absolute risk. Third, initiating and maintaining the maximum tolerated blood pressure reduction is a more important issue than choice of initial agent. Finally, and most importantly, the large majority of people have suboptimal blood pressure (e.g., systolic > 115 mm Hg) and so initiatives to lower blood pressure population-wide are an essential adjunct to targeted treatment programs.
Publisher: Elsevier BV
Date: 05-2019
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: SAGE Publications
Date: 05-2007
DOI: 10.1111/J.1468-2982.2007.01313.X
Abstract: These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33% MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 2020
Publisher: Wiley
Date: 08-2006
DOI: 10.1359/JBMR.060516
Abstract: Small birth size is associated with reduced adult bone mass. We determined if antenatal betamethasone exposure, birth weight, or prematurity affects peak bone mass in 174 adults. Antenatal betamethasone exposure did not. Lower birth weight and prematurity predicted reduced adult height. Slower fetal growth rather than prematurity predicted lower bone mass, but this lower bone mass was appropriate for reduced adult height. Small size at birth is reported to be associated with lower bone mass in adulthood. However, previous studies have not distinguished the relative contributions of length of gestation and fetal growth to size at birth. Fetal exposure to excess glucocorticoids has been proposed as a core mechanism underlying the associations between birth size and later disease risk. Antenatal glucocorticoids are given to pregnant women at risk for preterm delivery for the prevention of neonatal respiratory distress syndrome in their infants. We determined the relationship of antenatal exposure to betamethasone, birth weight, and prematurity to peak bone mass and femoral geometry in the adult survivors of the first randomized trial of antenatal glucocorticoids. We studied 174 young adults (mean age, 31 years) whose mothers participated in a randomized trial of antenatal betamethasone. Mothers received two doses of intramuscular betamethasone or placebo 24 h apart. Two thirds of participants were born preterm (<37 weeks gestation). We measured indices of bone mass and size and derived estimates of volumetric density and bone geometry from DXA assessments of the lumbar spine, femur, and total body. There were no differences between betamethasone-exposed and placebo-exposed groups in any of the lumbar spine, femur, or total body DXA measures. There was no effect of antenatal betamethasone on adult height, although leg length was increased relative to trunk length (p = 0.002). A lighter birth weight (p <or = 0.001) and lower gestational age (p = 0.013) were associated with shorter stature (height Z scores) at age 31 years. Prematurity had no effect on peak bone mass or femoral geometry. However, lower birth weight, independent of gestational age, was associated with lower later bone mass (p < 0.001 for lumbar spine and total body, p = 0.003 for femoral neck BMC). These effects on bone mass were related to bone size and not to estimates of volumetric density. In the femur, lower birth weight, independent of gestational age, was associated with narrowing of the upper shaft and narrow neck regions. Antenatal betamethasone exposure does not affect peak bone mass or femoral geometry in adulthood. Birth weight and prematurity predict adult height, but it is slower fetal growth, rather than prematurity, that predicts lower peak bone mass. The lower peak bone mass in those born small is appropriate for their adult height.
Publisher: Wiley
Date: 06-2016
DOI: 10.1111/JCH.12835
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: American Medical Association (AMA)
Date: 14-08-2018
Publisher: Oxford University Press (OUP)
Date: 05-2004
Publisher: Informa UK Limited
Date: 19-12-2006
Publisher: Elsevier BV
Date: 04-1999
Publisher: AMPCo
Date: 10-2014
DOI: 10.5694/MJA14.00675
Publisher: Springer Science and Business Media LLC
Date: 17-01-2018
DOI: 10.1038/S41387-017-0012-Y
Abstract: We aimed to evaluate the relationship between BMI and the risk of renal disease in patients with type 2 diabetes in the Action in Diabetes and Vascular Disease: PreterAx and DiamicroN Modified-Release Controlled Evaluation (ADVANCE) study. Participants were ided into six baseline BMI categories: .5 (underweight, n = 58) ≥18.5 to (normal, n = 2894) ≥25 to (overweight, n = 4340) ≥30 to (obesity grade 1, n = 2265) ≥35 to (obesity grade 2, n = 744) and ≥40 kg/m 2 (obesity grade 3, n = 294) those underweight were excluded. The composite outcome “major renal event” was defined as development of new macroalbuminuria, doubling of creatinine, end stage renal disease, or renal death. These outcomes and development of new microalbuminuria were considered in idually as secondary endpoints. During 5-years of follow-up, major renal events occurred in 487 (4.6%) patients. The risk increased with higher BMI. Multivariable-adjusted HRs (95% CIs), compared to normal weight, were: 0.91 (0.72–1.15) for overweight 1.03 (0.77–1.37) for obesity grade 1 1.42 (0.98–2.07) for grade 2 and 2.16 (1.34–3.48) for grade 3 ( p for trend = 0.006). These findings were similar across subgroups by randomised interventions (intensive versus standard glucose control and perindopril-indapamide versus placebo). Every additional unit of BMI over 25 kg/m 2 increased the risk of major renal events by 4 (1–6)%. Comparable results were observed with the risk of secondary endpoints. Higher BMI is an independent predictor of major renal events in patients with type 2 diabetes. Our findings encourage weight loss to improve nephroprotection in these patients.
Publisher: Springer Science and Business Media LLC
Date: 22-03-2018
DOI: 10.1038/NRDP.2018.14
Publisher: SAGE Publications
Date: 07-2009
DOI: 10.1111/J.1468-2982.2008.01788.X
Abstract: This study examined the effect of age on placebo response rates in rizatriptan trials in adults. Data from eight rizatriptan adult trials involving patients treating moderate/severe migraine attacks with rizatriptan 5 mg ( N = 1819), rizatriptan 10 mg ( N = 2046) or placebo ( N = 1322) were pooled for post hoc analysis. Logistic regression was used to model 2-h pain relief (reduction to mild or none) and 2-h pain freedom rates by treatment groups. Older patients had lower placebo response rates than younger patients the estimated odds ratio (older vs. younger) for a 10-year age increase was 0.83 for pain relief [95% confidence interval (CI) 0.75, 0.93] and 0.81 for pain freedom (95% CI 0.68, 0.97). The response proportion vs. age trend was flat for rizatriptan 5 mg and slightly increased for rizatriptan 10 mg. The treatment-by-age interaction was significant for pain relief ( P 0.001) and pain freedom ( P = 0.001), suggesting an increasing trend of treatment advantage of rizatriptan over placebo as age increased. Age appeared to be an important predictor of placebo response rate in rizatriptan trials, with older patients being less likely to respond to placebo and more likely to respond to rizatriptan.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2023
DOI: 10.1161/HYPERTENSIONAHA.122.20458
Abstract: Decisions about hypertension management are substantially influenced by blood pressure (BP) levels measured before and soon after starting BP lowering drugs. We aimed to assess the utility of short-term BP changes in in iduals in terms of long-term treatment response. Post hoc analyses of 2 randomized trials with 4-to-6 weeks active run-in for all participants, followed by randomization to active BP lowering treatment (combination perindopril±indapamide) or placebo. We categorized in iduals by degree of systolic BP (SBP) change during active run-in treatment and assessed associations with subsequent postrandomization placebo-corrected BP reduction, cardiovascular events, and tolerability. We included in iduals with baseline BP ≥140/90 mm Hg from the PROGRESS trial (Perindopril Protection Against Recurrent Stroke Study 4275 in iduals with cerebrovascular disease) and ADVANCE trial (The Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation 6610 in iduals with diabetes). During the active run-in period, the proportion of participants with initial SBP changes in 4 categories (SBP increase, 0–9.9 mm Hg decrease, 10–19.9 mm Hg decrease, and ≥20 mm Hg decrease) were 17%, 27%, 28%, and 28% in PROGRESS and 21%, 22%, 24%, and 33% in ADVANCE. Randomization to active therapy achieved similar placebo-corrected long-term BP reductions across the 4 initial SBP change groups in both trials ( P -values for heterogeneity .1). There was no significant difference in achieving BP /90 mm Hg at follow-up, major cardiovascular events, nor treatment tolerability according to the SBP change during active run-in period (all P -values .1). An in idual’s apparent BP change immediately after commencing therapy has limited clinical utility. Therefore, more emphasis should be given to use of evidence-based regimens and measures over the long-term to ensure sustained BP control. URL: www.clinicaltrials.gov Unique identifier: NCT00145925.
Publisher: American Institute of Physics
Date: 2009
DOI: 10.1063/1.3203241
Publisher: Elsevier BV
Date: 04-2018
Publisher: BMJ
Date: 10-2016
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-11-2016
DOI: 10.1161/CIRCULATIONAHA.116.023233
Abstract: Clinical lipid measurements do not show the full complexity of the altered lipid metabolism associated with diabetes mellitus or cardiovascular disease. Lipidomics enables the assessment of hundreds of lipid species as potential markers for disease risk. Plasma lipid species (310) were measured by a targeted lipidomic analysis with liquid chromatography electrospray ionization–tandem mass spectrometry on a case-cohort (n=3779) subset from the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation). The case-cohort was 61% male with a mean age of 67 years. All participants had type 2 diabetes mellitus with ≥1 additional cardiovascular risk factors, and 35% had a history of macrovascular disease. Weighted Cox regression was used to identify lipid species associated with future cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) and cardiovascular death during a 5-year follow-up period. Multivariable models combining traditional risk factors with lipid species were optimized with the Akaike information criteria. C statistics and NRIs were calculated within a 5-fold cross-validation framework. Sphingolipids, phospholipids (including lyso- and ether- species), cholesteryl esters, and glycerolipids were associated with future cardiovascular events and cardiovascular death. The addition of 7 lipid species to a base model (14 traditional risk factors and medications) to predict cardiovascular events increased the C statistic from 0.680 (95% confidence interval [CI], 0.678–0.682) to 0.700 (95% CI, 0.698–0.702 P .0001) with a corresponding continuous NRI of 0.227 (95% CI, 0.219–0.235). The prediction of cardiovascular death was improved with the incorporation of 4 lipid species into the base model, showing an increase in the C statistic from 0.740 (95% CI, 0.738–0.742) to 0.760 (95% CI, 0.757–0.762 P .0001) and a continuous net reclassification index of 0.328 (95% CI, 0.317–0.339). The results were validated in a subcohort with type 2 diabetes mellitus (n=511) from the LIPID trial (Long-Term Intervention With Pravastatin in Ischemic Disease). The improvement in the prediction of cardiovascular events, above traditional risk factors, demonstrates the potential of plasma lipid species as biomarkers for cardiovascular risk stratification in diabetes mellitus. URL: clinicaltrials.gov . Unique identifier: NCT00145925.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2009
Publisher: Wiley
Date: 16-07-2008
Publisher: Medical Journals Sweden AB
Date: 2000
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2019
DOI: 10.1161/HYPERTENSIONAHA.118.12414
Abstract: The optimal blood pressure (BP) goal in patients with diabetes mellitus remains controversial. We examined whether benefits and risks of intensified antihypertensive therapy in diabetes mellitus are influenced by either baseline BP or cardiovascular disease (CVD) risk. We studied 10 948 people with diabetes mellitus, at moderate-to-high risk, in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation). Cox models were used to determine whether baseline BP category or CVD risk modified the outcomes of combination perindopril-indapamide treatment, compared with placebo. During 4.3 years of follow-up, treatment with perindopril-indapamide versus placebo reduced mortality and major vascular (macrovascular or microvascular) events. There was no evidence of differences in these effects, regardless of baseline systolic BP (evaluated down to mm Hg P for heterogeneity, 0.85), diastolic BP (evaluated down to mm Hg P =0.49), or whether 10-year CVD risk was ≥20% or % ( P =0.08). The effects of randomized treatment on discontinuation of treatment because of cough or hypotension/dizziness were also statistically consistent across subgroups defined by baseline BP and CVD risk (all P ≥0.08). Adults with diabetes mellitus appear to benefit from more intensive BP treatment even at levels of BP and CVD risk that some guidelines do not currently recommend for intervention. URL: www.clinicaltrials.gov . Unique identifier: NCT00751972.
Publisher: CMA Joule Inc.
Date: 24-06-2013
DOI: 10.1503/CMAJ.121468
Publisher: John Wiley & Sons, Ltd
Date: 18-07-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2005
DOI: 10.1161/01.STR.0000170710.95689.41
Abstract: Background and Purpose— The cause of subarachnoid hemorrhage (SAH) is poorly understood and there are few large cohort studies of risk factors for SAH. We investigated the risk of SAH mortality and morbidity associated with common cardiovascular risk factors in the Asia-Pacific region and examined whether the strengths of these associations were different in Asian and Australasian (predominantly white) populations. Methods— Cohort studies were identified from Internet electronic databases, searches of proceedings of meetings, and personal communication. Hazard ratios (HRs) for systolic blood pressure (SBP), current smoking, total serum cholesterol, body mass index (BMI), and alcohol drinking were calculated from Cox models that were stratified by sex and cohort and adjusted for age at risk. Results— In idual participant data from 26 prospective cohort studies (total number of participants 306 620) that reported incident cases of SAH (fatal and/or nonfatal) were available for analysis. During the median follow-up period of 8.2 years, a total of 236 incident cases of SAH were observed. Current smoking (HR, 2.4 95% CI, 1.8 to 3.4) and SBP mm Hg (HR, 2.0 95% CI, 1.5 to 2.7) were significant and independent risk factors for SAH. Attributable risks of SAH associated with current smoking and elevated SBP (≥140 mm Hg) were 29% and 19%, respectively. There were no significant associations between the risk of SAH and cholesterol, BMI, or drinking alcohol. The strength of the associations of the common cardiovascular risk factors with the risk of SAH did not differ much between Asian and Australasian regions. Conclusions— Cigarette smoking and SBP are the most important risk factors for SAH in the Asia-Pacific region.
Publisher: Elsevier BV
Date: 08-2014
Publisher: Elsevier BV
Date: 12-2001
Publisher: Wiley
Date: 11-12-2007
DOI: 10.1111/J.1526-4610.2007.00954.X
Abstract: To confirm the efficacy of rizatriptan 10 mg orally disintegrating tablet (ODT) for the elimination of migraine-associated nausea. Pooled studies of rizatriptan analyzing elimination of nausea as a secondary endpoint showed that 65% of rizatriptan patients reported elimination of nausea at 2 hours compared with 41% of patients taking placebo. This was a multicenter, randomized, double-blind, placebo-controlled single-attack trial enrolling adult patients with at least a 6-month history of migraine who typically experience migraine-associated nausea. Patients treated a moderate or severe migraine headache at the earliest sign of nausea with either rizatriptan 10 mg ODT or placebo (2 : 1). The primary endpoint was elimination of nausea at 2 hours postdose, and the secondary endpoint was pain relief at 2 hours postdose. Although not statistically significant, a greater percentage of patients had elimination of nausea at 2 hours with rizatriptan compared with placebo (70.3% vs 62.0%, P = .165, odds ratio [95% CI] = 1.45 [0.86, 2.46]). When patients were grouped by baseline headache severity, rizatriptan showed a greater advantage than placebo for patients with moderate pain (rizatriptan 72.8% vs placebo 57.4%), but no difference for patients with severe pain (rizatriptan 67.7% vs placebo 66.7%). There were significantly more patients who achieved 2-hour pain relief with rizatriptan (69.7% vs 54.3%, P = .012, odds ratio [95% CI] = 1.94 [1.16, 3.25]). Although the efficacy of rizatriptan 10 mg ODT for the elimination of migraine-associated nausea was comparable to that seen in previous rizatriptan trials, the higher-than-usual placebo response prevented a finding of a statistically significant difference. There was a sizable difference in placebo response between patients who treated moderate vs severe migraine. Rizatriptan was effective for 2-hour pain relief.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2016
Publisher: Oxford University Press (OUP)
Date: 20-05-2008
Abstract: Large-scale observational studies show that lower blood pressure is associated with lower cardiovascular risk in both men and women although some studies have suggested that different outcomes between the sexes may reflect different responses to blood pressure-lowering treatment. The aims of these overview analyses were to quantify the effects of blood pressure-lowering treatment in each sex and to determine if there are important differences in the proportional benefits of treatment between men and women. Thirty-one randomized trials that included 103,268 men and 87,349 women contributed to these analyses. For each outcome and each comparison summary estimates of effect and 95% confidence intervals were calculated for men and women using a random-effects model. The consistency of the effects of each treatment regimen across the sexes was examined using chi(2) tests of homogeneity. Achieved blood pressure reductions were comparable for men and women in every comparison made. For the primary outcome of total major cardiovascular events there was no evidence that men and women obtained different levels of protection from blood pressure lowering or that regimens based on angiotensin-converting-enzyme inhibitors, calcium antagonists, angiotensin receptor blockers, or diuretics/beta-blockers were more effective in one sex than the other (all P-homogeneity > 0.08). All of the blood pressure-lowering regimens studied here provided broadly similar protection against major cardiovascular events in men and women. Differences in cardiovascular risks between sexes are unlikely to reflect differences in response to blood pressure-lowering treatments.
Publisher: American Diabetes Association
Date: 12-2004
DOI: 10.2337/DIACARE.27.12.2836
Abstract: OBJECTIVE—To assess the shape and strength of the association between usual blood glucose and cardiovascular disease (CVD) in Asian and Australasian cohorts and to determine the impact of adjusting for other determinants of CVD risk and excluding people with diabetes. RESEARCH DESIGN AND METHODS—Relative risk estimates and 95% CIs were calculated from Cox models, stratified by sex and cohort, and adjusted for age at risk on in idual participant data from 17 cohort studies. Repeat measurements of blood glucose were used to adjust for regression dilution bias. RESULTS—Fasting blood glucose data were available for 237,468 participants, and during ∼1.2 million person-years of follow-up, there were 1,661 stroke and 816 ischemic heart disease (IHD) events. Data were also available on 27,996 participants with nonfasting glucose measurements. Continuous positive associations were demonstrated between usual fasting glucose and the risks of CVD down to at least 4.9 mmol/l. Overall, each 1 mmol/l lower usual fasting glucose was associated with a 21% (95% CI 18–24%) lower risk of total stroke and a 23% (19–27%) lower risk of total IHD. The associations were similar in men and women, across age-groups, and in Asian compared with Australasian (Australia and New Zealand) populations. Adjusting for potential confounders or removing those with diabetes as baseline did not substantially affect the associations. Associations for nonfasting glucose were weaker than those with fasting glucose. CONCLUSIONS—Fasting blood glucose is an important determinant of CVD burden, with considerable potential benefit of usual blood glucose lowering down to levels of at least 4.9 mmol/l.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2004
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-04-2023
Publisher: Elsevier BV
Date: 11-2002
Publisher: Springer Science and Business Media LLC
Date: 10-2022
DOI: 10.1038/S41591-022-01974-1
Abstract: High systolic blood pressure (SBP) is a major risk factor for ischemic heart disease (IHD), the leading cause of death worldwide. Using data from published observational studies and controlled trials, we estimated the mean SBP–IHD dose–response function and burden of proof risk function (BPRF), and we calculated a risk outcome score (ROS) and corresponding star rating (one to five). We found a very strong, significant harmful effect of SBP on IHD, with a mean risk—relative to that at 100 mm Hg SBP—of 1.39 (95% uncertainty interval including between-study heterogeneity 1.34–1.44) at 120 mm Hg, 1.81 (1.70–1.93) at 130 mm Hg and 4.48 (3.81–5.26) at 165 mm Hg. The conservative BPRF measure indicated that SBP exposure between 107.5 and 165.0 mm Hg raised risk by 101.36% on average, yielding a ROS of 0.70 and star rating of five. Our analysis shows that IHD risk was already increasing at 120 mm Hg SBP, rising steadily up to 165 mm Hg and increasing less steeply above that point. Our study endorses the need to prioritize and strengthen strategies for screening, to raise awareness of the need for timely diagnosis and treatment of hypertension and to increase the resources allocated for understanding primordial prevention of elevated blood pressure.
Publisher: Massachusetts Medical Society
Date: 09-10-2014
Publisher: Oxford University Press (OUP)
Date: 08-1999
DOI: 10.1093/JAC/44.2.263
Abstract: Quinupristin/dalfopristin (Synercid), the first injectable streptogramin antibiotic available for the treatment of complicated gram-positive skin and skin structure infections, was compared with standard comparators (cefazolin, oxacillin or vancomycin) in one USA and one international trial. These two randomized, open-label trials of virtually identical design enrolled a total of 893 patients (450 quinupristin/dalfopristin, 443 comparator). The majority of patients had erysipelas, traumatic wound infection or clean surgical wound infection. Staphylococcus aureus was the most frequently isolated pathogen in both treatment groups and polymicrobial infection was more common in the quinupristin/dalfopristin group than in the comparator group. The clinical success rate (cure plus improvement) in the clinically evaluable population was equivalent between the two treatment groups (68.2% quinupristin/dalfopristin, 70.7% comparator 95% CI, -10.1, 5.1) despite a shorter mean duration of treatment for quinupristin/dalfopristin patients. In the bacteriologically evaluable population, by-patient and by-pathogen bacteriological eradication rates were somewhat lower for quinupristin/dalfopristin (65.8% and 66.6%, respectively) than for the comparator regimens (72.7% and 77.7%, respectively). The lower bacteriological response rates in the quinupristin/dalfopristin group were, in part, due to a higher rate of polymicrobial infections and a higher incidence of patients classified as clinical failure, a category which included premature discontinuation of treatment because of local venous adverse events. The bacteriological eradication rate for quinupristin/dalfopristin was higher in monomicrobial infections than in polymicrobial infections (72.6% versus 63.3%, respectively), whereas the corresponding rate for the comparator regimens was lower for monomicrobial infections than polymicrobial infections (70.8% versus 83.1%). This finding was not unexpected, since the spectrum of quinupristin/dalfopristin is focused on gram-positive pathogens and additional antibiotics to treat gram-negative bacteria were not required per protocol. The systemic tolerability of both treatment regimens was qualitatively similar. A higher rate of drug-related venous adverse events was reported for quinupristin/dalfopristin (66.2%) than for the comparator regimen (28.4%). Premature discontinuation of study drug was primarily due to adverse clinical events for quinupristin/dalfopristin (19.1%), whereas the most common reason for discontinuation among those receiving the comparator regimens was treatment failure (11.5%). Quinupristin/dalfopristin is an effective alternative for the treatment of hospitalized patients with complicated skin and skin structure infections due to quinupristin/ dalfopristin-susceptible gram-positive organisms, including methicillin- and erythromycin-resistant S. aureus.
Publisher: JMIR Publications Inc.
Date: 21-01-2011
DOI: 10.2196/JMIR.1553
Publisher: Japanese Society of Hypertension
Date: 1994
Publisher: Elsevier BV
Date: 08-2023
Publisher: Springer Science and Business Media LLC
Date: 22-06-2013
Abstract: Māori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a “polypill”) improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. Experienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-s ling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished. A total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per month. Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment. Differences between randomized Māori and non-Māori were evident (e.g. Maori were less likely to have established coronary artery disease). Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported. The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2006
Publisher: Elsevier BV
Date: 12-2007
Publisher: Elsevier BV
Date: 09-2003
Publisher: Elsevier BV
Date: 11-2016
Publisher: Elsevier BV
Date: 03-2003
Publisher: Wiley
Date: 11-2009
DOI: 10.1111/J.1526-4610.2009.01532.X
Abstract: To evaluate whether access to more liberal quantities of rizatriptan improves clinical outcome in patients with episodic migraine. Currently many pharmacy benefit programs limit the number of triptan tablets/injections per month based on perceived cost savings and the belief that too-frequent use of triptans may lead to medication overuse headache and headache chronification. This observer-blind, randomized, parallel-group study enrolled 197 subjects with migraine with or without aura. Subjects completed a 3-month baseline period to establish migraine frequency and then were randomly assigned to receive 9 (formulary limit [FL]) or 27 (clinical limit [CL]) tablets of 10 mg rizatriptan orally disintegrating tablet (ODT) per month for 3 months. The primary endpoint was change in the mean number of migraine days from the baseline to treatment period. There was no statistically significant difference between the FL and CL groups in mean number of migraine days (FL-CL LS mean: -0.08 [-0.39, 0.23] P = .613). Subjects in the CL group treated attacks at lower headache severity. No CL subjects were reported to have developed chronic migraine despite utilization of greater than 10 rizatriptan ODT tablets per month. Rizatriptan was generally well tolerated by both groups. Providing a greater quantity of rizatriptan ODT 10 mg did not reduce the number of migraine days compared with providing 9 tablets per month for this population with episodic migraine with a frequency of 3-8 migraines per month. Regardless of quantity provided, rizatriptan was generally well tolerated.
Publisher: Public Library of Science (PLoS)
Date: 19-12-2012
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2007
Publisher: Elsevier BV
Date: 09-2012
DOI: 10.1016/J.JAAD.2011.10.027
Abstract: Finasteride (1 mg) has been shown to increase vertex hair growth in men aged 18 to 60 years with male pattern hair loss and to increase frontal scalp hair growth in subjects aged 18 to 41 years. A secondary efficacy analysis was conducted to determine effects of finasteride (1 mg) on scalp hair growth in the 4 distinct scalp regions affected by male pattern hair loss. Multicenter, double-blind studies randomized patients with vertex hair loss (men aged 18-41 and 41-60 years) to finasteride (1 mg/d) or placebo. Efficacy was evaluated by review of standardized clinical photographs (global photographic assessment) of the vertex, anterior/mid scalp regions, and frontal and temporal hairlines over 24 months relative to baseline. At 24 months, treatment with finasteride resulted in statistically significant (P ≤ .05) hair growth versus placebo in all scalp regions. There was also a significant decrease in hair loss in the younger men treated with finasteride in all areas, but only in the vertex and anterior/mid scalp regions in the older men. A slightly higher incidence of drug-related sexual adverse experiences was reported in the finasteride group than in the placebo group, irrespective of age. These studies enrolled men with vertex pattern hair loss therefore, the findings may not be extrapolated to men with predominantly anterior/mid scalp, frontal, or temporal hair loss. Based on global photographic assessment, finasteride (1 mg) is able to increase hair growth in all areas of the scalp affected by male pattern hair loss.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2018
Publisher: Public Library of Science (PLoS)
Date: 07-03-2019
Publisher: BMJ
Date: 10-2019
DOI: 10.1136/BMJOPEN-2019-030536
Abstract: Forgetting to take a medication is the most common reason for non-adherence to self-administered medication. Dose administration aids (DAAs) are a simple and common solution to improve unintentional non-adherence for oral tablets. DAAs can be in the form of compartmentalised pill boxes, automated medication dispensing devices, blister packs and sachets packets. This protocol aims to outline the methods that will be used in a systematic review of the current literature to assess the impact of DAAs on adherence to medications and health outcomes. Randomised controlled trials will be identified through electronic searches in databases including EMBASE, MEDLINE, CINAHL and the Cochrane Library, from the beginning of each database until January 2020. Two reviewers will independently screen studies and extract data using the standardised forms. Data extracted will include general study information, characteristics of the study, participant characteristics, intervention characteristics and outcomes. Primary outcome is to assess the effects of DAAs on medication adherence. Secondary outcome is to evaluate the changes in health outcomes. The risk of bias will be ascertained by two reviewers in parallel using The Cochrane Risk of Bias Tool. A meta-analysis will be performed if data are homogenous. Ethics approval will not be required for this study. The results of the review described within this protocol will be disseminated through publication in a peer-reviewed journal and relevant conference presentations. CRD42018096087
Publisher: Wiley
Date: 28-04-2011
DOI: 10.1111/J.1360-0443.2011.03419.X
Abstract: To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR)=1.17, 95% confidence interval (CI): 1.02, 1.35, P=0.03], had a longer time to relapse (median 70 days versus 28 days, P<0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. This trial is registered with the Australasian Clinical Trials Network Number: ACTRN 12606000451505.
Publisher: Oxford University Press (OUP)
Date: 20-06-2012
Abstract: Multiple studies have examined the relationship between heart rate and mortality however, there are discrepancies in results. Our aim was to describe the relationship between resting heart rate (RHR) and both major cardiovascular (CV) outcomes, as well as all-cause mortality in the Asia-Pacific region. In idual data from 112,680 subjects in 12 cohort studies were pooled and analysed using Cox models, stratified by study and sex, and adjusted for age and systolic blood pressure. During a mean 7.4 years follow-up, 6086 deaths and 2726 fatal or nonfatal CV events were recorded. There was a continuous, increasing association between having a RHR above approximately 65 beats/min and the risk of both CV and all-cause mortality, yet there was no evidence of associations below this threshold. The hazard ratio (95% CI) comparing the extreme quarters of RHR (80+ v <65 beats/min) was 1.44 (1.29-1.60) for CV and 1.54 (1.43-1.66) for total mortality. These associations were not materially changed by adjustment for other risk factors and exclusion of the first 2 years of follow-up. Hazard ratios of a similar magnitude were found for ischemic and hemorrhagic stroke, but the hazard ratio for heart failure was higher (2.08, 95% CI 1.07-4.06) and for Coronary Heart Disease (CHD) was lower (1.11, 95% CI 0.93-1.31) than for stroke. RHR of above 65 beats/min has a strong independent effect on premature mortality and stroke, but a lesser effect on CHD. Lifestyle and pharmaceutical regimens to reduce RHR may be beneficial for people with moderate to high levels of RHR.
Publisher: Elsevier BV
Date: 03-2010
Abstract: Traditional methods to improve population diets have largely relied on in idual responsibility, but there is growing interest in structural interventions such as pricing policies. The aim was to evaluate the effect of price discounts and tailored nutrition education on supermarket food and nutrient purchases. A 2 x 2 factorial randomized controlled trial was conducted in 8 New Zealand supermarkets. A total of 1104 shoppers were randomly assigned to 1 of the following 4 interventions that were delivered over 6 mo: price discounts (12.5%) on healthier foods, tailored nutrition education, discounts plus education, or control (no intervention). The primary outcome was change in saturated fat purchased at 6 mo. Secondary outcomes were changes in other nutrients and foods purchased at 6 and 12 mo. Outcomes were assessed by using electronic scanner sales data. At 6 mo, the difference in saturated fat purchased for price discounts on healthier foods compared with that purchased for no discount on healthier foods was -0.02% (95% CI: -0.40%, 0.36% P = 0.91). The corresponding difference for tailored nutrition education compared with that for no education was -0.09% (95% CI: -0.47%, 0.30% P = 0.66). However, those subjects who were randomly assigned to receive price discounts bought significantly more predefined healthier foods at 6 mo (11% more mean difference: 0.79 kg/wk 95% CI: 0.43, 1.16 P < 0.001) and 12 mo (5% more mean difference: 0.38 kg/wk 95% CI: 0.01, 0.76 P = 0.045). Education had no effect on food purchases. Neither price discounts nor tailored nutrition education had a significant effect on nutrients purchased. However, the significant and sustained effect of discounts on food purchases suggests that pricing strategies hold promise as a means to improve population diets.
Publisher: Cambridge University Press (CUP)
Date: 06-2005
DOI: 10.1079/PHN2004704
Abstract: To estimate the burden of mortality in New Zealand due to higher-than-optimal body mass index (BMI) in 1997, as well as mortality that could be avoided in 2011 with feasible changes in mean population BMI. New Zealand. Comparative risk assessment methodology was used to estimate the attributable and avoidable mortality due to high BMI. Outcomes assessed were ischaemic heart disease (IHD), ischaemic stroke, type 2 diabetes mellitus, colorectal cancer and postmenopausal breast cancer. In 1997, 3154 deaths (11% of all deaths) in New Zealand were due to higher-than-optimal BMI ( kg m −2 ). This amounted to 83% of diabetes deaths, 24% of IHD deaths, 15% of ischaemic stroke deaths and 4% of all cancer deaths. If the projected increase in mean population BMI by 2011 was limited to 1.0 kg m −2 rather than 1.3 kg m −2 , approximately 385 deaths could be prevented annually, mainly from diabetes. These results quantify the importance of higher-than-optimal BMI as a major modifiable cause of premature death in New Zealand. Intervention policies that would have only modest effects on slowing the rate of increase in mean population BMI by 2011 could still prevent hundreds of deaths annually.
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: Springer Science and Business Media LLC
Date: 03-04-2014
Publisher: American Diabetes Association
Date: 22-03-2016
DOI: 10.2337/DC15-2322
Abstract: The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial reported that intensive glucose control prevents end-stage kidney disease (ESKD) in patients with type 2 diabetes, but uncertainty about the balance between risks and benefits exists. Here, we examine the long-term effects of intensive glucose control on risk of ESKD and other outcomes. Survivors, previously randomized to intensive or standard glucose control, were invited to participate in post-trial follow-up. ESKD, defined as the need for dialysis or kidney transplantation, or death due to kidney disease, was documented overall and by baseline CKD stage, along with hypoglycemic episodes, major cardiovascular events, and death from other causes. A total of 8,494 ADVANCE participants were followed for a median of 5.4 additional years. In-trial HbA1c differences disappeared by the first post-trial visit. The in-trial reductions in the risk of ESKD (7 vs. 20 events, hazard ratio [HR] 0.35, P = 0.02) persisted after 9.9 years of overall follow-up (29 vs. 53 events, HR 0.54, P & 0.01). These effects were greater in earlier-stage CKD (P = 0.04) and at lower baseline systolic blood pressure levels (P = 0.01). The effects of glucose lowering on the risks of death, cardiovascular death, or major cardiovascular events did not differ by levels of kidney function (P & 0.26). Intensive glucose control was associated with a long-term reduction in ESKD, without evidence of any increased risk of cardiovascular events or death. These benefits were greater with preserved kidney function and with well-controlled blood pressure.
Publisher: BMJ
Date: 02-2019
DOI: 10.1136/BMJOPEN-2018-022637
Abstract: We aimed to evaluate the effects on depression scores of a lifestyle-focused cardiac support programme delivered via mobile phone text messaging among patients with coronary heart disease (CHD). Substudy and secondary analysis of a parallel-group, single-blind randomised controlled trial of patients with CHD. A tertiary hospital in Sydney, Australia. The Tobacco, Exercise and dieT MEssages programme comprised four text messages per week for 6 months that provided education, motivation and support on diet, physical activity, general cardiac education and smoking, if relevant. The programme did not have any specific mental health component. Depression scores at 6 months measured using the Patient Health Questionnaire-9 (PHQ-9). Treatment effect across subgroups was measured using log-binomial regression model for the binary outcome (depressed/not depressed, where depressed is any score of PHQ-9 ≥5) with treatment, subgroup and treatment by subgroup interaction as fixed effects. Depression scores at 6 months were lower in the intervention group compared with the control group, mean difference 1.9 (95% CI 1.5 to 2.4, p .0001). The frequency of mild or greater depressive symptoms (PHQ-9 scores≥5) at 6 months was 21/333 (6.3%) in the intervention group and 86/350 (24.6%) in the control group (relative risk (RR) 0.26, 95% CI 0.16 to 0.40, p .001). This proportional reduction in depressive symptoms was similar across groups defined by age, sex, education, body mass index, physical activity, current smoking, current drinking and history of depression, diabetes and hypertension. In particular, the rates of PHQ-9 ≥5 among people with a history of depression were 4/44 (9.1%) vs 29/62 (46.8%) in intervention vs control (RR 0.19, 95% CI 0.07 to 0.51, p .001), and were 17/289 (5.9%) vs 57/288 (19.8%) among others (RR 0.30, 95% CI 0.18 to 0.50, p .001). Among people with CHD, a cardiac support programme delivered via mobile phone text messaging was associated with fewer symptoms of mild-to-moderate depression at 6 months in the treatment group compared with controls. ACTRN12611000161921.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 18-08-2022
Publisher: Springer Science and Business Media LLC
Date: 18-03-2014
Publisher: American Medical Association (AMA)
Date: 11-07-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2019
Publisher: Ubiquity Press, Ltd.
Date: 09-2015
Publisher: Springer Science and Business Media LLC
Date: 16-08-2004
Publisher: Elsevier BV
Date: 09-2002
Abstract: Current treatment of acute stroke remains unsatisfactory. This review presents experimental and clinical data which suggest that mild induced hypothermia could be a potent and practicable neuroprotective treatment of acute ischaemic stroke and intracerebral haemorrhage. Hypothermia, if proven to be safe, effective and widely practicable in patients with acute stroke, could have an enormous positive impact on reducing the burden of stroke worldwide. Critical issues that will need to be considered in a well designed randomised controlled trial of induced hypothermia in acute stroke patients are discussed.
Publisher: Elsevier BV
Date: 03-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 25-07-2023
Publisher: Wiley
Date: 12-2022
DOI: 10.1002/JPPR.1843
Abstract: Tablet splitting is a widely prevalent practice resulting from the need to alter doses into two or more parts and optimise medicine in in idual patients. If a tablet is split unequally problems may arise. The aim of the study was to summarise the literature measuring the effect of tablet splitting on dose accuracy. MEDLINE, EMBASE, CINAHL and Cochrane were searched and studies published prior to January 2020 investigating the effect of splitting tablets on dose accuracy were included. Studies investigating any drug, where the tablet was split, were potentially eligible. Two independent reviewers conducted the screening and extracted the data. Meta‐analyses assessing the effect of tablet splitting on dose accuracy were performed. (Study registration: PROSPERO CRD42018106252). Of 25 included studies, 16 examined the effect of tablet splitting on weight of the tablet, one on drug concentration and eight examined both. Meta‐analysis found small variation between split tablets (0.87% weight variation, 95% confidence interval 0.63%–1.11% and 0.24% drug content variation, 95% confidence interval 0.06%–0.43%). There was some inconsistency across trial results for weight but not for drug content variation ( I 2 50% and I 2 1%, respectively). Splitting method and tablet characteristics were predictors of accuracy. Although tablet splitting may influence dose accuracy, this analysis suggests that the weight and drug content variation is minimal, regardless of method and tablet characteristics. Additional studies, such as those examining drug plasma concentrations and effect on patient health outcomes for ex le blood pressure and cholesterol levels, are needed to better understand the role of tablet splitting on dose accuracy.
Publisher: SAGE Publications
Date: 09-2007
DOI: 10.1111/J.1468-2982.2007.01391.X
Abstract: The presence of cutaneous allodynia may predict response to triptans. Identical randomized double-blind studies were conducted comparing the efficacy of rizatriptan 10 mg or placebo administered within 1 h of headache onset, while pain was mild. The primary endpoint was freedom from pain at 2 h. Presence of symptoms suggesting cutaneous sensitivity (SCS) at baseline and at 2 h post-treatment was recorded. Before treatment, 29% of rizatriptan patients and 22% of placebo patients reported SCS. At 2 h, the percentage of patients with SCS was significantly decreased with rizatriptan. The presence of SCS pre-treatment was not predictive of response to rizatriptan. Most patients with SCS at 2 h were non-responders. Early treatment with rizatriptan significantly reduced the percentage of patients with SCS at 2 h. The presence of SCS at baseline did not predict pain-free response, but presence of SCS at 2 h correlated with lack of a 2-h pain-free response.
Publisher: JMIR Publications Inc.
Date: 24-01-2012
DOI: 10.2196/JMIR.1857
Publisher: Wiley
Date: 27-04-2009
DOI: 10.1111/J.1526-4610.2009.01412.X
Abstract: To examine the efficacy of rizatriptan 10-mg orally disintegrating tablet (ODT) for treating migraines of mild intensity soon after onset, with or without patient-specific migraine education. Studies have shown rizatriptan tablet efficacy in early migraine treatment. In this randomized, placebo-controlled, double-blind, factorial design study, adults with a history of migraine were assigned to rizatriptan 10-mg ODT patient education (personalized summary of early migraine signs and symptoms) or placebo patient education in a 1 : 1 : 1 : 1 ratio. Patients were instructed to treat 1 attack at the earliest time they knew that their headache was a migraine, while pain was mild. During the next 24 hours, patients assessed pain severity, associated symptoms, functional disability, use of rescue medication, and treatment satisfaction. The primary endpoint was pain freedom at 2 hours a key secondary endpoint was 24-hour sustained pain freedom. Of 207 patients randomized to treatment, 188 (91%) treated a study migraine. Significantly more patients taking rizatriptan reported pain freedom at 2 hours compared with placebo (66.3% vs 28.1%, P < .001). Similarly, significantly more patients taking rizatriptan reported 24-hour sustained pain freedom (52.2% vs 17.7%, P < .001). A greater proportion of patients in the rizatriptan + education group reported pain freedom at 2 hours compared with those in the rizatriptan + no education group (71.7% vs 60.9%, P = .430). Few adverse events were reported. Rizatriptan 10-mg ODT, when taken early, while headache pain is mild, was superior to placebo at providing pain freedom at 2 hours and 24-hour sustained pain freedom.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-07-2023
Abstract: Sodium glucose cotransporter‐2 inhibitors reduce systolic blood pressure (SBP), but whether they affect SBP variability is unknown. There also remains uncertainty regarding the prognostic value of SBP variability for different clinical outcomes. Using in idual participant data from the CANVAS (Canagliflozin Cardiovascular Assessment Study) Program and CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial, we assessed the effect of canagliflozin on SBP variability in people with type 2 diabetes across 4 study visits over 1.5 years as measured by standard deviation, coefficient of variation, and variability independent of the mean. We used multivariable Cox regression models to estimate associations of SBP variability with cardiovascular, kidney, and mortality outcomes. In 11 551 trial participants, canagliflozin modestly lowered the standard deviation of SBP variability (−0.25 mm Hg [95% CI, –0.44 to −0.06]), but there was no effect on coefficient of variation (0.02% [95% CI, –0.12 to 0.16]) or variability independent of the mean (0.08 U [95% CI, –0.11 to 0.26]) when adjusting for correlation with mean SBP. Each 1 standard deviation increase in standard deviation of SBP variability was independently associated with higher risk of hospitalization for heart failure (hazard ratio [HR], 1.19 [95% CI, 1.02–1.38]) and all‐cause mortality (HR, 1.12 [95% CI, 1.01–1.25]), with consistent results observed for coefficient of variation and variability independent of the mean. Increases in SBP variability were not associated with kidney outcomes. In people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease, higher visit‐to‐visit SBP variability is independently associated with risks of hospitalization for heart failure and all‐cause mortality. Canagliflozin has little to no effect on SBP variability, independent of its established SBP‐lowering effect. URL: www.clinicaltrials.gov Unique identifiers: NCT01032629, NCT01989754, NCT02065791.
Publisher: SAGE Publications
Date: 07-01-2022
DOI: 10.1177/17474930211068671
Abstract: Patients who suffer intracerebral hemorrhage (ICH) are at very high risk of recurrent ICH and other serious cardiovascular events. A single-pill combination (SPC) of blood pressure (BP) lowering drugs offers a potentially powerful but simple strategy to optimize secondary prevention. The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC “Triple Pill,” three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH. An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130–160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety. Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required s le size should be achieved by 2024. Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.
Publisher: Massachusetts Medical Society
Date: 26-11-2015
DOI: 10.1056/NEJME1513301
Publisher: Springer Science and Business Media LLC
Date: 2001
Abstract: Random errors in the measurement of 10 commonly investigated cardiovascular risk factors (systolic and diastolic blood pressure, blood cholesterol, blood glucose, pulse rate, body mass index (BMI), cigarette consumption, passive smoking, alcohol intake and physical exercise) were assessed in a general population cohort (n = 2517) and a workforce cohort (n = 8008). Random errors were estimated from regression dilution ratios (lower ratios imply greater random error, and a ratio of one implies no random error). All of the risk factors, except for BMI (which had regression dilution ratios of 0.93 and 0.98 in the two cohorts), were measured with substantial levels of random error. Particularly low regression dilution ratios were observed for physical exercise (0.28 and 0.39) and pulse rate (0.47 and 0.56). For each of these risk factors, with the possible exception of BMI, associations with long-term average values could be importantly biased toward the null unless appropriate corrections are made.
Publisher: Public Library of Science (PLoS)
Date: 20-03-2018
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 29-11-2005
DOI: 10.1161/CIRCULATIONAHA.105.537472
Abstract: Background— Although interest in multifactorial interventions for cardiovascular disease is increasing, data on the strength and shape of the joint effects of blood pressure and cholesterol levels on the risk of cardiovascular disease are scarce, confined primarily to coronary heart disease (CHD) mortality in early middle-aged Western populations. Methods and Results— This analysis included 29 cohorts from Asia (78% of the total 380 216 participants) and 7 from Australia and New Zealand, with a total of 2 547 447 person-years of observation. Stratified time-dependent Cox proportional-hazards analyses were used to regress time until first event against baseline systolic blood pressure (SBP) and total cholesterol levels. A total of 3079 CHD and 4247 stroke events occurred stroke subtypes were confirmed by CT, MRI, or necropsy in 1471 (35%) stroke events. Usual values of SBP were strongly linearly associated with ischemic stroke, hemorrhagic stroke, and CHD. The slope of the association with SBP became steeper with decreasing levels of cholesterol for ischemic stroke ( P =0.007) and CHD ( P ≤0.0001). For ex le, for the cholesterol groups of .75, 4.75 to 5.49, 5.50 to 6.24, and ≥6.25 mmol/L, each 10–mm Hg–higher systolic pressure was associated with 34% (95% CI, 30% to 37%), 28% (95% CI, 21% to 35%), 25% (95% CI, 18% to 32%), and 21% (95% CI, 13% to 27%) higher CHD risk, respectively. Adjustments for other leading cardiovascular risk factors made no appreciable differences in these results. Conclusions— In Asia-Pacific populations, there are hazards of increasing SBP at all cholesterol levels and hazards of increasing cholesterol at all levels of SBP, but the associations of SBP with CHD risk and ischemic stroke risk are slightly steeper among those with low cholesterol levels. The joint effects of SBP and total cholesterol on cardiovascular disease seem consistent across various Western and Asian populations.
Publisher: American Medical Association (AMA)
Date: 03-2016
DOI: 10.1001/JAMAINTERNMED.2015.7667
Abstract: Adherence to long-term therapies in chronic disease is poor. Traditional interventions to improve adherence are complex and not widely effective. Mobile telephone text messaging may be a scalable means to support medication adherence. To conduct a meta-analysis of randomized clinical trials to assess the effect of mobile telephone text messaging on medication adherence in chronic disease. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL (from database inception to January 15, 2015), as well as reference lists of the articles identified. The data were analyzed in March 2015. Randomized clinical trials evaluating a mobile telephone text message intervention to promote medication adherence in adults with chronic disease. Two authors independently extracted information on study characteristics, text message characteristics, and outcome measures as per the predefined protocol. Odds ratios and pooled data were calculated using random-effects models. Risk of bias and study quality were assessed as per Cochrane guidelines. Disagreement was resolved by consensus. Sixteen randomized clinical trials were included, with 5 of 16 using personalization, 8 of 16 using 2-way communication, and 8 of 16 using a daily text message frequency. The median intervention duration was 12 weeks, and self-report was the most commonly used method to assess medication adherence. In the pooled analysis of 2742 patients (median age, 39 years and 50.3% [1380 of 2742] female), text messaging significantly improved medication adherence (odds ratio, 2.11 95% CI, 1.52-2.93 P < .001). The effect was not sensitive to study characteristics (intervention duration or type of disease) or text message characteristics (personalization, 2-way communication, or daily text message frequency). In a sensitivity analysis, our findings remained robust to change in inclusion criteria based on study quality (odds ratio, 1.67 95% CI, 1.21-2.29 P = .002). There was moderate heterogeneity (I2 = 62%) across clinical trials. After adjustment for publication bias, the point estimate was reduced but remained positive for an intervention effect (odds ratio, 1.68 95% CI, 1.18-2.39). Mobile phone text messaging approximately doubles the odds of medication adherence. This increase translates into adherence rates improving from 50% (assuming this baseline rate in patients with chronic disease) to 67.8%, or an absolute increase of 17.8%. While promising, these results should be interpreted with caution given the short duration of trials and reliance on self-reported medication adherence measures. Future studies need to determine the features of text message interventions that improve success, as well as appropriate patient populations, sustained effects, and influences on clinical outcomes.
Publisher: Cambridge University Press (CUP)
Date: 06-2007
DOI: 10.1017/S136898000735249X
Abstract: To pilot the design and methodology for a large randomised controlled trial (RCT) of two interventions to promote healthier food purchasing: culturally appropriate nutrition education and price discounts. A 12-week, single-blind, pilot RCT. Effects on food purchases were measured using in idualised electronic shopping data (‘Shop ’N Go’ system). Partial data were also collected on food expenditure at other (non-supermarket) retail outlets. A supermarket in Wellington, New Zealand. Eligible customers were those who were the main household shoppers, shopped mainly at the participating store, and were registered to use the Shop ’N Go system. Ninety-seven supermarket customers (72% women age 40 ± 9.6 years, mean ± standard deviation) were randomised to one of four intervention groups: price discounts, nutrition education, a combination of price discounts and nutrition education, or control (no intervention). There was a 98% follow-up rate of participants, with 85% of all reported supermarket purchases being captured via the electronic data collection system. The pilot did, however, demonstrate difficulty recruiting Maori, Pacific and low-income shoppers using the electronic register and mail-out. This pilot study showed that electronic sales data capture is a viable way to measure effects of study interventions on food purchases in supermarkets, and points to the feasibility of conducting a large-scale RCT to evaluate the effectiveness of price discounts and nutrition education. Recruitment strategies will, however, need to be modified for the main trial in order to ensure inclusion of all ethnic and socio-economic groups.
Publisher: Wiley
Date: 2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2010
Publisher: Wiley
Date: 16-11-2022
DOI: 10.1111/JVH.13629
Abstract: The availability of direct‐acting antivirals (DAAs) sparked efforts to eliminate hepatitis C virus (HCV) in Australia. We evaluated whether an educational intervention of a 1‐h discussion among staff using audit and feedback data from the MedicineInsight GP programme would improve DAA uptake. Of 296 eligible general practices in MedicineInsight, 11% opted out. Randomization stratified by practice caseload allocated 130 practices to the intervention arm and 129 to control. The primary outcome was the number of patients started on DAAs over 6 months using the negative binomial regression model adjusted for DAA prescription history and clustering by practice. Data for analysis were available for 78% of practices, which included 101 practices and 2469 DAA‐naive patients with confirmed ossible HCV in the intervention arm, and 100 practices and 2466 patients in the control arm. At baseline, 49.5% of practices had prescribed ≥1 DAA in the past year 18.9% of HCV patients had already been treated with DAAs the mean age of DAA‐naive HCV patients was 43 years old, and 57% were men. Over 6 months, 43 patients in the intervention arm and 36 in the control arm started DAAs (adjusted IRR 1.19 95% CI 0.67–2.11, p = 0.55). In the first 3 months, 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88–3.58 p = 0.111). Few patients were started on DAAs, and a facilitated discussion in HCV management did not lead to a significant increase. Alternative measures, such as incentivizing GP initiations or patients, are suggested to address remaining barriers to DAA uptake in Australian primary care. Australian New Zealand Clinical Trial Registry (ANZCTR) Registration Number: ACTRN12619000508178p.
Publisher: Wiley
Date: 10-01-2005
Publisher: Wiley
Date: 30-10-2020
DOI: 10.1111/DOM.13878
Abstract: To assess the effects of intensive glucose control on the risk of major clinical outcomes according to estimated glomerular filtration rate (eGFR) levels in people with type 2 diabetes. Of 11 140 ADVANCE trial participants, 11 096 with baseline eGFR measurements were included, and classified into three eGFR groups: ≥90 mL/min/1.73 m
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2019
Publisher: Springer Science and Business Media LLC
Date: 15-11-2018
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2018
Publisher: Oxford University Press (OUP)
Date: 08-2008
Publisher: Springer Science and Business Media LLC
Date: 27-08-2021
Publisher: Elsevier BV
Date: 09-2018
Publisher: Wiley
Date: 06-2008
DOI: 10.1111/J.1526-4610.2007.01053.X
Abstract: To evaluate the efficacy and tolerability of coadministration of rizatriptan and acetaminophen in the acute treatment of migraine. Rizatriptan is a selective 5-HT1B/1D agonist approved for the acute treatment of migraine. Acetaminophen has been studied for acute migraine treatment. In consideration of the prominent central and peripheral mechanisms in migraine, the use of "multi-mechanism therapy" is gaining momentum in the treatment of acute migraine attacks. This was a randomized, double-blind, placebo-controlled trial conducted at 10 centers. Eligible patients with migraine according to International Headache Society criteria treated a single migraine attack of moderate or severe intensity within 4 h from pain onset. Patients were randomized into 1 of 4 groups (rizatriptan 10 mg + acetaminophen 1000 mg [RA], rizatriptan alone [R], acetaminophen alone [A], and placebo [P]). There were 3 co-primary hypotheses tested sequentially for 2-h pain relief: (1) RA would be superior to P (2) if the first was fulfilled, RA would be superior to A and (3) if the first 2 were fulfilled, RA would be superior to R. Of 173 patients who treated a migraine, 123 patients (71.5%) achieved pain relief within 2 h. RA (90%) was significantly better than P (46%) and A (70%), but only numerically better than R (77%) for 2-h pain relief. No significant differences were seen between the active treatment groups in adverse events. Rizatriptan coadministered with acetaminophen achieved 2 of the 3 primary hypotheses, proving superior to both acetaminophen and placebo for 2-h pain relief, but failing to achieve superiority to rizatriptan alone. RA was as well tolerated as each of the in idual agents.
Publisher: Springer Science and Business Media LLC
Date: 26-10-2015
DOI: 10.1007/S11886-015-0673-X
Abstract: Cardiovascular disease (CVD) is the leading cause of mortality globally. Most people with cardiovascular disease do not take long-term cholesterol-lowering, anti-platelet and blood pressure-lowering medications despite proven benefits. Fixed-dose combination pills ('polypills') have been shown to improve adherence to these recommended medications with corresponding improvements in risk factors such as blood pressure and low-density lipoprotein (LDL) cholesterol. Among patients not taking the full complement of recommended CVD preventive therapies, use of a polypill-based strategy (i.e. initiating treatment with single-pill combination medication then titrating further therapy as needed) has large potential benefits in reducing global morbidity and mortality. Despite this, few polypills are available on the market due to market failure in the funding of research and development for affordable non-communicable disease medicines. Additionally, defining a path to market has been problematic in that fixed-dose combinations with multiple different drug classes included are quite novel, and regulatory processes to review these types of applications are not well established. Despite these delays, progress is slowly being made.
Publisher: Oxford University Press (OUP)
Date: 06-04-2017
Publisher: Oxford University Press (OUP)
Date: 17-11-2015
DOI: 10.1093/IJNP/PYV124
Publisher: Elsevier BV
Date: 12-2003
Publisher: Elsevier BV
Date: 07-2011
Publisher: Elsevier BV
Date: 08-2019
Publisher: Springer Science and Business Media LLC
Date: 11-04-2023
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2016
DOI: 10.1161/HYPERTENSIONAHA.115.06814
Abstract: The population health effect and cost-effectiveness of implementing intensive blood pressure goals in high-cardiovascular disease (CVD) risk adults have not been described. Using the CVD Policy Model, CVD events, treatment costs, quality-adjusted life years, and drug and monitoring costs were simulated over 2016 to 2026 for hypertensive patients aged 35 to 74 years. We projected the effectiveness and costs of hypertension treatment according to the 2003 Joint National Committee (JNC)-7 or 2014 JNC8 guidelines, and then for adults aged ≥50 years, we assessed the cost-effectiveness of adding an intensive goal of systolic blood pressure mm Hg for patients with CVD, chronic kidney disease, or 10-year CVD risk ≥15%. Incremental cost-effectiveness ratios $50 000 per quality-adjusted life years gained were considered cost-effective. JNC7 strategies treat more patients and are more costly to implement compared with JNC8 strategies. Adding intensive systolic blood pressure goals for high-risk patients prevents an estimated 43 000 and 35 000 annual CVD events incremental to JNC8 and JNC7, respectively. Intensive strategies save costs in men and are cost-effective in women compared with JNC8 alone. At a willingness-to-pay threshold of $50 000 per quality-adjusted life years gained, JNC8+intensive had the highest probability of cost-effectiveness in women (82%) and JNC7+intensive the highest probability of cost-effectiveness in men (100%). Assuming higher drug and monitoring costs, adding intensive goals for high-risk patients remained consistently cost-effective in men, but not always in women. Among patients aged 35 to 74 years, adding intensive blood pressure goals for high-risk groups to current national hypertension treatment guidelines prevents additional CVD deaths while saving costs provided that medication costs are controlled.
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: Ubiquity Press, Ltd.
Date: 06-2015
Publisher: Elsevier BV
Date: 10-2019
Publisher: Wiley
Date: 21-06-2022
DOI: 10.1111/BCP.15435
Abstract: Gout is the most common form of inflammatory arthritis in men. Despite the availability of effective urate-lowering therapies (ULT), the management of gout is suboptimal due to poor persistence with ULT. This study examined national prescribing patterns of ULT to determine persistence with allopurinol in Australia. A 10% s le of the Australian Pharmaceutical Benefits Scheme dispensing claims database was used to identify in iduals initiated on allopurinol between April 2014 and December 2019. The number of allopurinol scripts dispensed was used to estimate persistence with allopurinol. Persistence was defined as the number of months from initiation until discontinuation (last prescription with no further scripts acquired for a period thereafter). Kaplan-Meier curves were used to examine persistence, while Cox regression analysis was used to examine the influence of gender, concomitant colchicine and age. The largest drop in persistence occurred immediately after initiation, with 34% of patients discontinuing allopurinol 300-mg therapy in the first month. Median persistence with allopurinol 300 mg was 5 months (95% confidence interval 4.76-5.24), with around 63% of in iduals not persisting with this therapy for more than 12 months. Concomitant prescription of colchicine on the day of allopurinol initiation only occurred in 7% of allopurinol initiations. No increase in persistence was observed for those co-prescribed colchicine. Persistence with allopurinol was poor. More effective methods targeting prescribers, patients and systems are required to promote persistence with allopurinol. Improving persistence to allopurinol is an important public health goal given the proven potential of this medication to eliminate gout.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2005
DOI: 10.1161/01.STR.0000181115.59173.42
Abstract: Background and Purpose— Patients with atrial fibrillation have a high risk of stroke and other vascular events even if anticoagulated. The primary objective here is to determine whether routine blood pressure–lowering provides additional protection for this high-risk patient group. Methods— This study was a subsidiary analysis of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS)—a randomized, placebo-controlled trial that established the beneficial effects of blood pressure–lowering in a heterogeneous group of patients with cerebrovascular disease. A total of 6105 patients were randomly assigned to either active treatment (2 to 4 mg perindopril for all participants plus 2.0 to 2.5 mg indapamide for those without an indication for or a contraindication to a diuretic) or matching placebo(s). Outcomes are total major vascular events, cause-specific vascular outcomes, and death from any cause. Results— There were 476 patients with atrial fibrillation at baseline, of whom 51% were taking anticoagulants. In these patients, active treatment lowered mean blood pressure by 7.3/3.4 mm Hg and was associated with a 38% (95% confidence interval [CI], 6 to 59) reduction in major vascular events and 34% (95% CI, −13 to 61) reduction in stroke. The benefits of blood pressure–lowering in patients with atrial fibrillation were achieved irrespective of the use of anticoagulant therapy ( P homogeneity=0.8) or the presence of hypertension ( P homogeneity=0.4). Conclusions— For most patients with atrial fibrillation, routine blood pressure–lowering is likely to provide protection against major vascular events additional to that conferred by anticoagulation.
Publisher: American Society of Clinical Oncology (ASCO)
Date: 20-04-2005
Abstract: This is the first study in which the NK 1 -receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index–Emesis questionnaire. Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5% P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6% P = .019). Both treatments were generally well tolerated. The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.
Publisher: Elsevier BV
Date: 11-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2017
No related grants have been discovered for Anthony Rodgers.