A multicenter comparative trial of lovastatin and pravastatin in the treatment of hypercholesterolemia. The Lovastatin Pravastatin Study Group

Abstract

A randomized, controlled, double-blind trial in 672 hypercholesterolemic patients evaluated the efficacy and safety profile of lovastatin and pravastatin across their usually recommended dosage ranges (lovastatin 20 to 80 mg/day and pravastatin 10 to 40 mg/day). After a 7-week placebo and diet run-in period, patients with low-density lipoprotein (LDL) cholesterol > 160 mg/dl (4.1 mmol/liter) were randomized to 20 mg/day of lovastatin, or 10 mg/day of pravastatin for 6 weeks. The doses were then increased to 40 and 80 mg/day of lovastatin, and 20 and 40 mg/day of pravastatin at weeks 6 and 12, respectively. Efficacy and safety evaluations were performed at weeks 6, 12 and 18. The mean percent changes from baseline in LDL cholesterol at weeks 6, 12 and 18 were -28, -33 and -39%, respectively, with lovastatin, and -19, -25 and -27%, respectively, with pravastatin. All changes were significantly different from 0 (p < 0.001), and the between-group differences were highly significant (p < 0.001). The frequency of adverse events leading to discontinuation was low (2.9% with lovastatin, and 2.4% with pravastatin), with no significant differences between groups. Across the recommended dosage ranges, lovastatin was more effective than pravastatin in reducing total and LDL cholesterol; however, both agents had similar safety profiles.