THE LIPID-LOWERING EFFECTS OF ATORVASTATIN, A NEW HMG-COA REDUCTASE INHIBITOR - RESULTS OF A RANDOMIZED, DOUBLE-MASKED STUDY

This randomized, placebo-controlled, double-masked, parallel-group tri al assessed the serum cholesterol-lowering effects of atorvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, over 26 weeks in patients with primary hypercholesterolemia. Thirty-nine pati ents from four centers in the United States were originally randomized to one of two treatment groups and received either atorvastatin 10 mg (20 patients) or placebo (19 patients) once daily. Atorvastatin rapid ly and significantly reduced serum total cholesterol, low-density lipo protein cholesterol (LDL-C), and apolipoprotein B levels. LDL-C was re duced 35% with atorvastatin 10 mg compared with a 0% increase in LDL-C in the placebo group. Atorvastatin significantly reduced triglyceride levels, with improvements occurring over time. At 26 weeks, triglycer ide levels were reduced by 21% with atorvastatin treatment compared wi th a 14% increase with placebo. The drug was well tolerated and no cli nically significant laboratory abnormalities were detected.