COMPARISON OF ONE-YEAR EFFICACY AND SAFETY OF ATORVASTATIN VERSUS LOVASTATIN IN PRIMARY HYPERCHOLESTEROLEMIA

This double-blind study to evaluate long-term efficacy and safety of a torvastatin was performed in 31 community- and university-based resear ch centers in the USA to directly compare a new 3-hydroxy-3-methyl-glu toryl-coenlyme A reductase inhibitor (reductase inhibitor) to an accep ted drug of this class in patients with moderate hypercholesterolemia. Participants remained on a cholesterol-lowering diet throughout the s tudy. One thousand forty-nine patients were randomized to receive ator vastatin 10 mg, lovastatin 20 mg, or placebo. At 16 weeks the placebo group was randomized to-either atorvastatin or lovastatin treatment. A t 22 weeks, patients who had not met; low-density lipoprotein (LDL) ch olesterol target levels doubled the dose of reductase inhibitor. Effic acy evaluation was mean percent change from baseline in LDL cholestero l, triglycerides, total cholesterol, high-density-lipoprotein choleste rol, and apolipoprotein B (apoB). Safety profiles as determined by cha nge from baseline in laboratory evaluations, ophthalmologic parameters , and reporting of adverse events were similar for the 2 reductase inh ibitors. After 52 weeks, the atorvastatin group maintained a significa ntly greater reduction in LDL cholesterol (-37% vs -29%), triglyceride (-16% vs -8%), total cholesterol (-27% vs -21%), and apoB (-30% vs -2 2%) (p < 0.05). More patients receiving atorvastatin achieved LDL chol esterol target levels than did lovastatin patients (78% vs 63%, respec tively), particularly those with coronary heart disease (37% vs 11%, r espectively). Atorvastatin is highly effective and well tolerated in p atients with primary hypercholesterolemia with no increased risk of ad verse events. (C) 1997 by Excerpta Medica, Inc.