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The Heart Protection Study was a large randomized controlled trial run by the Clinical Trial Service Unit, and funded by the Medical Research Council (MRC) and the British Heart Foundation (BHF) in the United Kingdom. It studied the use of statin (simvastatin 40 mg) medication and vitamin supplementation (vitamin E, vitamin C and beta carotene) in patients that are at risk for cardiovascular disease.
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Results
An outline of the study protocol was published in 1999[1]. Initial results[2] were published in 2002, which indicated that vitamins made little difference in modifying cardiovascular risk, but that simvastatin could significantly reduce the risk of cardiovascular events. Further results, from 2003 and 2004, focused on the role of simvastatin in diabetics[3] and preventing stroke[4]. A 2005 paper analyses the cost-effectiveness of a prescribing strategy similar to the one employed in the study[5].
Interpretation
The HPS is to date the largest study to investigate the use of statins in the prevention of cardiovascular disease. While there have been concerns about side-effects (myopathy and rhabdomyolysis), these were very rare in the study.
The number needed to treat in the study was 57 to prevent all deaths, and 19 to prevent all cardiovascular "events". Cancer risk was nonsignificantly lower in the treatment group (this has been the subject of other studies). No worsening of lung disease was found, an initial concern with statin drugs, but neither did simvastatin decrease osteoporosis (although it was expected to due to its pharmacological parallels with the antiosteoporotic bisphosphonates).
References
- ^ MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. Eur Heart J 1999;20:725-41. PDF. PMID 10329064.
- ^ Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22. PMID 12114036.
- ^ Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 2003;361:2005-16. PMID 12814710
- ^ Collins R, Armitage J, Parish S, Sleight P, Peto R; Heart Protection Study Collaborative Group. Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20536 people with cerebrovascular disease or other high-risk conditions. Lancet 2004;363:757-67. PMID 15016485.
- ^ Mihaylova B, Briggs A, Armitage J, Parish S, Gray A, Collins R; Heart Protection Study Collaborative Group. Cost-effectiveness of simvastatin in people at different levels of vascular disease risk: economic analysis of a randomised trial in 20,536 individuals. Lancet 2005;365:1779-85. PMID 15910950.
See also
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- This page was last modified on 2 June 2008, at 14:30.
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