Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia

Background. Lowering the blood cholesterol level may reduce the risk of coronary heart disease. This double-blind study was designed to determine whether the administration of pravastatin to men with hypercho- lesterolemia and no history of myocardial infarction re- duced the combined incidence of nonfatal myocardial in- farction and death from coronary heart disease. Methods. We randomly assigned 6595 men, 45 to 64 years of age, with a mean ( � SD) plasma cholesterol lev- el of 272 � 23 mg per deciliter (7.0 � 0.6 mmol per liter) to receive pravastatin (40 mg each evening) or placebo. The average follow-up period was 4.9 years. Medical rec- ords, electrocardiographic recordings, and the national death registry were used to determine the clinical end points. Results. Pravastatin lowered plasma cholesterol lev- els by 20 percent and low-density lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo. There were 248 definite coronary events (speci- fied as nonfatal myocardial infarction or death from coro- nary heart disease) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with prava- statin, 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 reduction, P � 0.001), death from coronary heart disease (definite cases alone: 28 percent reduction, P � 0.13; definite plus suspected cases: 33 percent reduc- tion, P � 0.042), and death from all cardiovascular causes (32 percent reduction, P � 0.033). There was no excess of deaths from noncardiovascular causes in the pravastatin group. We observed a 22 percent reduction in the risk of death from any cause in the pravastatin group (95 percent confidence interval, 0 to 40 percent; P � 0.051). Conclusions. Treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial infarction. (N Engl J Med 1995;333:1301-7.)