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[Clinical study of the month. The MRC/BHF Heart Protection Study]
1Service de Cardiologie, CHU Liège.
Insights
Simvastatin significantly reduced all-cause mortality and major cardiovascular events in adults with existing vascular disease or diabetes. Antioxidant vitamin supplementation showed no significant benefit.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Context:
- Coronary heart disease and other occlusive arterial diseases pose significant mortality risks.
- Diabetes mellitus is a major risk factor for cardiovascular complications.
- Statins are widely used to manage hyperlipidemia and reduce cardiovascular risk.
Purpose:
- To evaluate the efficacy of simvastatin in reducing mortality and major vascular events in high-risk adults.
- To assess the impact of antioxidant vitamin supplementation on cardiovascular outcomes.
- To investigate the effects in a 2x2 factorial design comparing simvastatin vs. placebo and antioxidant vitamins vs. placebo.
Summary:
- A 5-year randomized trial involving 20,536 adults with coronary heart disease, other occlusive arterial disease, or diabetes mellitus.
- Simvastatin (40 mg daily) significantly reduced all-cause mortality by 12.3% and coronary deaths by 18%.
- Significant reductions were observed for myocardial infarction, stroke, and revascularization events; antioxidant vitamins showed no benefit.
Impact:
- Simvastatin demonstrates substantial benefits across various patient subgroups, including women, the elderly, and those with specific cholesterol levels.
- The study highlights the effectiveness of statin therapy in preventing major cardiovascular events and mortality.
- Antioxidant vitamin supplementation did not provide any cardiovascular benefits in this high-risk population.
Abstract:
20,536 adults (15,454 men and 5,082 women, aged 40-80 years) with coronary heart disease, other occlusive arterial disease or diabetes mellitus were randomly allocated to receive 40 mg simvastatin daily or matching placebo. In addition to being randomized to compare simvastatin vs placebo, all patients were also randomized to compare antioxidant vitamin supplementation (vitamin E 600 mg/day, vitamin C 250 mg/day and betacarotene 20 mg/day) vs placebo in a "2 x 2 factorial" design. Duration of the study was 5 years. All-cause mortality was significantly reduced among patients allocated to simvastatin (-12.3%) due to a highly significant (-18%) reduction in the coronary death rate, a marginally significant reduction in other vascular deaths and a non-significant reduction in non-vascular deaths. There were highly significant reductions (of about one-quarter) in the first event rate for non-fatal myocardial infarction and coronary death (combined), for non-fatal and fatal stroke and for coronary or non-coronary revascularization. The beneficial effect of simvastatin was seen in all sub-categories which were studied and, particularly: women vs men; patients aged > 70 years vs those aged < 70 years; patients with LDL cholesterol < vs > 116 mg/dl, or total cholesterol < vs > 193 mg/dl. The treatment was well tolerated and the annual risk of myopathy was 0.01%. All comparisons between antioxidant vitamin supplementation and placebo failed to reveal any difference in favour or against the supplementation which was otherwise well tolerated. These important results and their implications will be briefly discussed.