CHOLESTEROL AND RECURRENT EVENTS - A SECONDARY PREVENTION TRIAL FOR NORMOLIPIDEMIC PATIENTS

Although elevated plasma cholesterol levels represent a well-establish ed and significant risk for developing atherosclerosis, there is a wid e spectrum of cholesterol levels in patients with coronary artery dise ase (CAD). Most secondary prevention studies have generated convincing evidence that cholesterol reduction in patients with high cholesterol levels is associated with improved clinical outcome by reducing risk of further cardiovascular events. However, other risk factors may play ct prominent role in the pathogenesis of coronary disease in the majo rity of patients with near-normal cholesterol values. The Cholesterol and Recurrent Events (CARE) study was designed to address whether the pharmacologic reduction of cholesterol levels with the 3-hydroxy-3-met hyiglutaryl coenzyme A (HMG-CoA) reductase inhibitor, pravastatin, wou ld reduce the sum of fatal coronary artery disease (CAD) and nonfatal myocardial infarction (MI) in patients who have survived an Ms yet hav e a total cholesterol value <240 mg/dl (<6.2 mmol/liter). The other in clusion criteria for this study were age 21-75 years, low density lipo protein (LDL) cholesterol levels of 115-174 mg/dl (3.0-4.5 mmol/liter) , and fasting serum triglyceride levels <350 mg/dl (<4.0 mmol/liter). A total of 4,159 eligible consenting patients without other study excl usions were then randomly assigned to receive either pravastatin 40 mg daily or matching placebo in addition to their individualized convent ional therapy. The trial was designed to have a median follow-vp of 5 years. Study endpoints will be evaluated with respect to predefined su bgroups according to baseline lipid values, age, gender, prior cardiov ascular risk factors, and history. The CARE study should add important and unique information to the evolving field of cholesterol reduction in patients with ischemic heart disease by directly testing the quest ion of whether pharmacologic cholesterol reduction benefits the majori ty of patients with CAD and cholesterol levels <240 mg/dl (<6.2 mmol/l iter).