Pii: 0002-9149(93)90214-w

The present study was designed to test the effect of pravastatin, a new, 9hydroxy+methylglutaryl coenzyme A reductase inhibitor, on the progression of coronary artery disease in patients with moderate hypercholesterolemia. Angiographic eb try criteria included the presence of 21 stenosis 250% in a major epicardial coronary artery, and certiication of film quality through the core an@ography laboratory. Patients qualified for random ixation if after diet stabilization their low density lipoprotein cholesterol concentrations were 2130 and cl90 mg/dl, and triglycerides were 1350 mg/dl. Pravastatin (40 mg) or placebo is adminis tered once daily at bedtime. Arteriography will be repeated at the end of 3 years of treatment. The primary end point of the study is the change in * solute mean coronary artery diameter. During a 99month recruitment period, 44,145 patients were screened, and 408 were randomized. The most frequent reason for excludi* patients dulc ing the screenhtg and dietary lea&in periods was a low senun cholesterol level. A large proportion of patients with documented coronary artery di+ ease have cholesterol concentrations that are considered to be normal or only modestly iu creased. Adherence to strict standards of quality control for di@tal analysis of angiograms ensures that baseline anfgograms can be interpreted at the end of Syear follow-up. (Am J Cardiol1993;72:31-35)