PREVENTION OF CORONARY HEART-DISEASE WITH PRAVASTATIN IN MEN WITH HYPERCHOLESTEROLEMIA

Background. Lowering the blood cholesterol level may reduce the risk o f coronary heart disease. This double-blind study was designed to dete rmine whether the administration of pravastatin to men with hyperchole sterolemia and no history of myocardial infarction reduced the combine d incidence of nonfatal myocardial infarction and death from coronary heart disease. Methods. We randomly assigned 6595 men, 45 to 64 years of age, with a mean (+/-SD) plasma cholesterol level of 272+/-23 mg pe r deciliter (7.0+/-0.6 mmol per liter) to receive pravastatin (40 mg e ach evening) or placebo. The average follow-up period was 4.9 years. M edical records, electrocardiographic recordings, and the national deat h registry were used to determine the clinical end points. Results. Pr avastatin lowered plasma cholesterol levels by 20 percent and low-dens ity lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo. There were 248 definite coronary events (specifi ed as nonfatal myocardial infarction or death from coronary heart dise ase) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P<0.001). There were similar reductions in the risk of definite nonfatal myocardial infarctions (31 percent redu ction, P<0.001), death from coronary heart disease (definite cases alo ne: 28 percent reduction, P=0.13; definite plus suspected cases: 33 pe rcent reduction, P=0.042), and death from all cardiovascular causes (3 2 percent reduction, P=0.033). There was no excess of deaths from nonc ardiovascular causes in the pravastatin group. We observed a 22 percen t reduction in the risk of death from any cause in the pravastatin gro up (95 percent confidence interval, 0 to 40 percent; P=0.051). Conclus ions. Treatment with pravastatin significantly reduced the incidence o f myocardial infarction and death from cardiovascular causes without a dversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial in farction.