PREVENTION OF CARDIOVASCULAR EVENTS AND DEATH WITH PRAVASTATIN IN PATIENTS WITH CORONARY HEART-DISEASE AND A BROAD RANGE OF INITIAL CHOLESTEROL LEVELS

Background In patients with coronary heart disease and a broad range o f cholesterol levels, cholesterol-lowering therapy reduces the risk of coronary events, but the effects on mortality from coronary heart dis ease and overall mortality have remained uncertain. Methods In a doubl e-blind, randomized trial, we compared the effects of pravastatin (40 mg daily) with those of a placebo over a mean follow-up period of 6.1 years in 9014 patients who were 31 to 75 years of age. The patients ha d a history of myocardial infarction or hospitalization for unstable a ngina and initial plasma total cholesterol levels of 155 to 271 mg per deciliter. Both groups received advice on following a cholesterol-low ering diet. The primary study outcome was mortality from coronary hear t disease. Results Death from coronary heart disease occurred in 8.3 p ercent of the patients in the placebo group and 6.4 percent of those i n the pravastatin group, a relative reduction in risk of 24 percent (9 5 percent confidence interval, 12 to 35 percent; P < 0.001). Overall m ortality was 14.1 percent in the placebo group and 11.0 percent in the pravastatin group (relative reduction in risk, 22 percent; 95 percent confidence interval, 13 to 31 percent; P < 0.001). The incidence of a ll cardiovascular outcomes was consistently lower among patients assig ned to receive pravastatin; these outcomes included myocardial infarct ion (reduction in risk, 29 percent; P < 0.001), death from coronary he art disease or nonfatal myocardial infarction (a 24 percent reduction in risk, P < 0.001), stroke (a 19 percent reduction in risk, P = 0.048 ), and coronary revascularization (a 20 percent reduction in risk, P < 0.001). The effects of treatment were similar for all predefined subg roups. There were no clinically significant adverse effects of treatme nt with pravastatin. Conclusions Pravastatin therapy reduced mortality from coronary heart disease and overall mortality, as compared with t he rates in the placebo group, as well as the incidence of all prespec ified cardiovascular events in patients with a history of myocardial i nfarction or unstable angina who had a broad range of initial choleste rol levels. (C) 1998, Massachusetts Medical Society.