EXPANDED CLINICAL-EVALUATION OF LOVASTATIN (EXCEL) STUDY RESULTS - 2-YEAR EFFICACY AND SAFETY FOLLOW-UP

The Expanded Clinical Evaluation of Lovastatin study, a randomized, do uble-blind, placebo and diet-controlled multicenter trial, evaluated t he efficacy and tolerability of lovastatin over 48 weeks in 8,245 pati ents with moderately severe hypercholesterolemia. During year 1 of fol low-up of the full cohort, lovastatin at 20 or 40 mg/day, or 20 or 40 mg twice daily, produced dose-dependent decreases in low-density lipop rotein (LDL) cholesterol (24% to 40%) and triglyceride levels (10% to 19%), and increases in high-density lipoprotein (HDL) cholesterol (6.6 % to 9.5%). In all, 977 patients continued their original blinded trea tment for an additional year. In year 2, the U)L cholesterol response to lovastatin was maintained, the triglyceride reductions were somewha t less, and the increases in HDL cholesterol were moderately greater t han in year 1. Succesive transaminase elevations >3 times the upper li mit of normal were observed in only 1 patient in year 2, yielding a cu mulative 2-year incidence of from 0.1% (placebo or lovastatin 20 mg/da y) to 1.9% (lovastatin 80 mg/day). Myopathy occurred in only 1 patient during year 2, and over the 2 year study was observed rarely and only at lovastatin dosages of 40 and 80 mg/day. This study indicates that lovastatin maintains its efficacy over long-term follow-up, particular ly in effectively lowering LDL cholesterol, is generally well tolerate d, and has a favorable safety profile.