Study Design

Patients Enrolled: 9,014; 10-year follow-up: 7,721
Mean Follow-up: 6.1 years + 10-year follow-up
Mean Patient Age: 31-75 years
Female: 17%

Patient Populations:

Acute myocardial infarction (MI) or had a hospital discharge diagnosis of unstable angina between 3 and 36 months before study entry. Patients entered an 8-week-long single-blind placebo run-in phase during which they received dietary advice aimed at reducing their fat intake to <30% of total energy intake. For patients to qualify for the study, the plasma total cholesterol level measured 4 weeks before randomization was required to be 155-271 mg/dl, and the fasting triglyceride level <445 mg/dl (5.0 mmol/L).

Exclusions:

Clinically significant medical or surgical event within 3 months before study entry, cardiac failure, renal or hepatic disease, or current use of any cholesterol-lowering agents

Primary Endpoints:

The primary study outcome was death from CHD. Deaths from CHD were further classified as death due to fatal MI, sudden death, death in the hospital after possible MI, or death due to heart failure or another coronary cause.

Secondary Endpoints:

Secondary outcomes were death from any cause; death from cardiovascular causes; death from CHD or nonfatal MI; MI; stroke; nonhemorrhagic stroke; coronary revascularization (coronary angioplasty, coronary artery bypass surgery, or both); number of days in the hospital; serum lipid levels; and the relation of changes in lipid levels to the occurrence of cardiovascular endpoints.

Drug/Procedures Used:

In a double-blind, randomized trial, the effects of pravastatin (40 mg daily) with those of a placebo over a mean follow-up period of 6.1 years in 9,014 patients who were 31-75 years of age were compared. The patients had a history of MI or hospitalization for unstable angina and initial plasma total cholesterol levels of 155-271 mg/dl. Both groups received advice on following a cholesterol-lowering diet. The primary study outcome was mortality from CHD.