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QUESTION: In patients with a high 5 year risk of death, does simvastatin reduce mortality and vascular events?
Randomised (allocation concealed*), blinded (participants, clinicians, data collectors, and outcome assessors),* placebo controlled trial with mean follow up of 5 years.
69 UK hospitals.
20 536 patients who were 40–80 years of age (28% were ≥70 y of age, 75% men); had nonfasting total cholesterol levels ≥3.5 mmol/l; and had a substantial 5 year risk of death because of a history of coronary heart disease (CHD), occlusive disease of noncoronary arteries, or diabetes mellitus or a history of treated hypertension (in men ≥65 y of age). Exclusion criteria included a clear indication for statin therapy according to the patient‘s doctor; abnormal liver or renal function; muscle problems; concurrent treatment with cyclosporin, fibrates, or high dose niacin; potential for pregnancy; and serious medical conditions. Follow up was 99.7%.
Run in treatment consisted of 4 weeks of placebo and 4–6 weeks of simvastatin, …
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