Heart protection study
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The Heart Protection Study is a large randomized controlled trial by the Medical Research Council (MRC) and the British Heart Foundation (BHF) in the United Kingdom. It studies 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.
20,536 patients with history of coronary artery disease, peripheral arterial disease or diabetes, were randomly allocated to receive either simvastatin (40 mg daily) or a placebo. These patients were followed up over a period of 5 years for occurrence of any fatal or non- fatal events, along with incidence of cancer and other causes of major mortality.
The results of this study are tabulated as follows:
- All cause mortality significantly reduced in the simvastatin group compared to the placebo group. A highly significant proportional reduction in the coronary death rate, marginally significant reduction in other vascular deaths and a non-significant reduction in non-vascular deaths was noted in the simvastatin group.
- A highly significant reduction in first event rate for non-fatal/fatal myocardial infarction or coronary death, non-fatal/fatal stroke, and for coronary/non-coronary revascularization was noted in the simvastatin group compared to the placebo group.
- This reduction in first event rate was not significant in the first year, whereas found to be highly significant in subsequent years during each separate year.
- The annual excess risk of myopathy with simvastatin 40 mg daily was about 0.01 %.
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).
Long term treatment with simvastatin in addition to the existing treatment protocols safely gives an additional benefit to a wide range of high risk patients by reducing mortality.