Exaggerated report of benefits in a flawed long term statin. An intervention trial evaluating rosuvastatin documented a 25% increase in diabetes risk with. We assessed the potential benefit of treatment for lowrisk and highrisk groups in the west of scotland coronary prevention study woscops population, and compared the benefits of primary and secondary prevention of coronary heart disease chd by lipid lowering with the benefits of blood pressure reduction in the primary. Social deprivation is a major factor in health inequality. Lipidmodifying therapy trials with statins west of scotland coronary prevention study reference shepherd et al. In the present investigation, 1542 men in the west of scotland coronary prevention study. However, in the very few studies conducted, substantial uncertainty exists regarding this relationship. Longterm intervention with pravastatin in ischemic disease lipid, cholesterol and recurrent events care, and west of scotland coronary prevention study woscops, the american journal of cardiology on. The west of scotland coronary prevention study woscops was the first to show net benefits with a statin in primary prevention. S trong evidence of the favourable cost effectiveness of pravastatin prophylaxis to prevent cardiovascular disease in canadian men has been shown by adapting the economic model of the west of scotland coronary prevention study woscops to the canadian setting. Backgroundthe west of scotland coronary prevention study was a primary prevention trial that demonstrated the effectiveness of pravastatin 40 mgd in reducing morbidity and mortality from coronary heart disease chd in moderately hypercholesterolemic men.
The west of scotland coronary prevention study woscops was a randomised, doubleblind, placebo controlled trial of pravastatin. Woscops, 1995 trial summary pdf trial summary a randomised clinical trial investigating the effect of pravastatin versus placebo in men aged 4564 yr with no history of myocardial infarction and with raised plasma cholesterol levels ldl cholesterol of at least 155 mgdl, total cholesterol of at least 252 mgdl. The aim of the present study was to determine the association of the ccr2 val64ile polymorphism with the development of coronary artery disease in the woscops study sample set. Design features and baseline characteristics of the lipid longterm. Looking for online definition of woscops or what woscops stands for. Plasma leptin and the risk of cardiovascular disease in. The study has a primary outcome of coronary mortality, and is designed to detect an 18%. Alternatively, you can download the pdf file directly to your computer, from where it can be opened using a pdf reader. The main conclusions of our report are that individuals with no risk factors other than mild hypercholesterolaemia have a low risk of a major chd event over 5 years, and might therefore not merit the use of an expensive treatment, whereas possession of at least one additional risk factor is an indication for more aggressive investigation and assessment. Pdf on oct 31, 2017, uffe ravnskov and others published serious bias in 20 year followup study of statin trial find, read and cite all the research you need on researchgate. Methods woscops west of scotland coronary prevention study randomized men with raised lowdensity lipoprotein cholesterol and no history of myocardial infarction to pravastatin 40 mg once daily or placebo for 5 years. The investigators are to be commended for their efforts to provide this relevant information to practising.
The west of scotland coronary prevention study, also known as woscops, was a randomized, doubleblind, placebocontrolled clinical trial, published in 1995. Longterm effects of statin treatment in elderly people. Prevention of coronary heart disease with pravastatin in. The evolving role of statins in the management of atherosclerosis. It has been hypothesised that socioeconomically deprived people age more rapidly than their more advantaged counterparts and this is biologically manifest in shorter telomeres. Statins appear to modestly increase the risk of incident diabetes. Download free acrobat reader dc software, the only pdf viewer that lets you read, search, print, and interact with virtually any type of pdf file. Findings a total of 443 cases and 1003 controls from the west of scotland coronary prevention study woscops were genotyped for the val64ile polymorphism.
Pravastatin or atorvastatin evaluation and infection. It compared 40mg of the lipidlowering drug pravastatin to placebo in 6, 595 men who had a mean cholesterol of 7 mmoll but no previous history of a heart attack. Woscops, a primaryprevention study with 6595 men aged 45 to 64 years with elevated cholesterol levels, was one of the pioneering statintherapy trials when it was published in 1995. An important example of the latter is the 20 year report of the west of scotland coronary prevention study woscops. Nested casecontrol study, drawing samples of dna from the biological bank of a cohort study. A total of 443 cases and 1003 controls from the west of scotland coronary prevention study woscops were. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
The bmj reports on the findings of a study on long term 20 year treatment with a statin in the woscops trial by. In the uk residence in a socially deprived area is associated with an increase in mortality from coronary heart disease chd. They were more successful than anticipated and it was clear from the woscops study that the clinical benefit bore no relationship to cholesterol lowering. West of scotland coronary prevention study wikipedia. The first study west of scotland coronary prevention study woscops that evaluated this association reported a small protective effect but used nonstandardized criteria for diabetes diagnosis.
Objective to determine the risk of cardiovascular events and death in patients receiving statin treatment for cholesterol regulation. Woscops west of scotland coronary prevention study. Download free adobe acrobat reader dc software for your windows, mac os and android devices to view, print, and comment on pdf documents. Longterm impact on healthcare resource utilization of. Relativism and lowdensity lipoprotein cholesterol jacc.
The investigators are to be commended for their efforts to. Serious bias in 20 year followup study of statin trial. Highsensitivity cardiac troponin, statin therapy, and. What levels of cholesterol should be treated for primary. Initial studies explored the impact of statin therapy on coronary artery disease cad. In the case of older trials, data might have been destroyed, misplaced, exist in paper form only, or lack the variables necessary for linkage. Genetics and coronary artery disease sciencedirect. The results of these extended followup studies are consistent in that there was no evidence of. Influence of pravastatin and plasma lipids on clinical. Cholesterol and recurrent events study and with chd in the placebo arm of the woscops west of scotland coronary prevention study trial and. The west of scotland coronary prevention study woscops was a.
To measure the frequency of genotypes of the hfe haemochromatosis gene in patients recruited to the west of scotland coronary prevention study woscops, and relate them to the subsequent occurrence of coronary clinical events. Woscops randomized 6595 middleaged men with hyperlipidemia and no previous history of mi to pravastatin or placebo. So said jaime caro, one of the developers of the woscops economic model, at the third. Reactivation of dormant trials will not be without barriers. Analyses from the woscops 5 year randomised trial and 20year observational followup. Design, rationale, and baseline characteristics of the. The west of scotland coronary prevention study group. Background leptin plays a role in fat metabolism and correlates with insulin resistance and other markers of the metabolic syndrome, independent of total adiposity. Statins and allcause mortality in highrisk primary. Relationship of sex to diabetes risk in statin trials. Objective although statin therapy reduces cardiovascular risk, its relationship with the development of diabetes is controversial.
The aim of the study was to examine the effect of pravastatin in preventing non fatal mi or death from coronary artery disease. We assessed the potential benefit of treatment for lowrisk and highrisk groups in the west of scotland coronary prevention study woscops population, and compared the benefits of primary and secondary prevention of coronary heart disease chd by lipid lowering with the benefits of blood pressure reduction in the primary prevention of stroke. We did a subgroup analysis of placebotreated men in the woscops population by age, vascular disease at trial entry, and other established. The woscops study groupbaseline characteristics and screening. To assess the impact on healthcare resource utilization, costs, and quality of life over 15 years from 5 years of statin use in men without a history of myocardial infarction in the west of scotland coronary prevention study woscops.
Background lowering the blood cholesterol level may reduce the risk of coronary heart disease. The levels of cholesterol that should be treated for primary prevention are based on lowdensity lipoprotein cholesterol ldlc levels of 100 mgdl to 190 mgdl and vary according to whether the patients risk is high, moderate, or low. Longterm followup of the west of scotland coronary prevention. Woscops, a primaryprevention study with 6595 men aged 45 to 64 years with elevated cholesterol levels, was one of the pioneering. No authors listed this paper describes the design of the west of scotland coronary prevention study woscops which is a primary prevention trial involving men aged 4564 yr with raised plasma cholesterol levels.
Pdf serious bias in 20 year followup study of statin trial. Read design, rationale, and baseline characteristics of the prospective pravastatin pooling ppp projecta combined analysis of three largescale randomized trials. While an early trial the west of scotland coronary prevention study woscops suggested possible protection against diabetes 1, the jupiter study justification for the use of statins in prevention. Screening experience and baseline characteristics in the west of scotland coronary prevention study. Longterm safety and efficacy of lowering lowdensity lipoprotein. Haemochromatosis gene mutations and risk of coronary heart. Woscops definition of woscops by medical dictionary. Published in 1995, the innovative woscops study was a clinically driven primary prevention randomised controlled trial rct. The west of scotland coronary prevention group nov 16, p 391 purports to have performed a subgroup analysis of placebotreated men in the woscops population for the purpose of determining which risk factors are associated with the highest absolute risk of coronary heart disease chd.
Older epidemiological and randomized studies of cholesterol lowering had raised safety concerns. Woscops is listed in the worlds largest and most authoritative dictionary database of. Extended followup of the woscops trial supports statin. Background the prospective study of pravastatin in the elderly at risk prosper. Plasma cardiac troponin i concentration was measured with a highsensitivity assay at baseline and at 1 year in 3,318 participants. In their analysis of the woscops west of scotland coronary prevention study, ford et al. Woscops care lipid afcaps texcaps ncep atp iii update 2004 hps proveit ascotlla prosper allhatllt. Statins in the prevention and treatment of heart failure. Clinical trial outcome data have been subject exhaustively to metaanalysis that has reinforced the findings of individual studies and filled in. They found that hstn was reduced by statin and that the.
This is illustrated using the west of scotland coronary prevention study woscops. The main aim of this thesis is to investigate the role of computerised record linkage in clinical trial and epidemiological followup. The pravastatin or atorvastatin evaluation and infection therapy thrombolysis in myocardial infarction 22, also known as proveit timi 22, was a randomized, doubleblind, clinical trial that recruited 4,162 people admitted within 10 days of an acute coronary event and randomised them to the lipidlowering drugs pravastatin 40mg or atorvastatin 80mg and a 10 day course of. Overview of basic study design and biostatistics prominent landmark clinical trials. Analyses from the woscops 5year randomised trial and 20year observational followup. Association of the trp719arg polymorphism in kinesinlike protein 6 with myocardial infarction and coronary heart disease in 2 prospective trials. Identifying patients at risk for coronary heart disease. The west of scotland coronary prevention study woscops was the first trial to demonstrate a significant reduction in cv events with statin therapy for primary prevention. The present analysis examines the extent to which differences in ldl and other plasma lipids both at baseline and.
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