EFFICACY AND TOLERABILITY OF LOVASTATIN IN 459 AFRICAN-AMERICANS WITHHYPERCHOLESTEROLEMIA

A paucity of substantive data from clinical drug trials is available s pecifically evaluating the effects of therapy for hypercholesterolemia in African-Americans, even though a substantial number are candidates for medical advice and intervention for high blood cholesterol. The e fficacy and safety of lovastatin in 459 African-Americans with hyperch olesterolemia were studied in the Expanded Clinical Evaluation of Lova statin study, a multicenter, double-blind, diet- and placebo-controlle d trial. This trial involved 8,245 patients who were randomly assigned , regardless of race, to receive placebo or lovastatin at doses of 20 mg once daily, 40 mg once daily, 20 mg twice daily, or 40 mg twice dai ly for 48 weeks. Among African-Americans, lovastatin produced sustaine d, dose-related (p <0.001) decreases in low-density lipoprotein choles terol (20% to 38%), total cholesterol (14% to 28%), and triglycerides (8% to 15%). From 75% to 96% of African-Americans treated with lovasta tin achieved the National Cholesterol Education Program goal of low-de nsity lipoprotein cholesterol <160 mg/dl, and from 33% to 71% achieved the goal <130 mg/dl. The safety profile of lovastatin in African-Amer icans was generally favorable. A relatively high incidence of creatine kinase levels greater than the upper limit of: normal was observed in African-Americans during the study, i.e., 63% in the placebo group an d similar levels in lovastatin treatment groups, Lovastatin is highly effective and generally well tolerated as therapy for primary hypercho lesterolemia in African-Americans.