EFFICACY AND SAFETY OF PRAVASTATIN IN AFRICAN-AMERICANS WITH PRIMARY HYPERCHOLESTEROLEMIA

Background: Coronary artery disease strikes early and may prove partic ularly severe in persons of African-American descent. Therefore, we st udied the lipid-lowering efficacy and safety of pravastatin sodium (20 mg/d), a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, i n 245 African-American patients with primary hypercholesterolemia. Met hods: After 4 weeks on an American Heart Association phase I low-fat d iet, patients were randomized in a double-blind manner to either prava statin or placebo in a 3:1 ratio. Results: After 12 weeks of pravastat in treatment, low-density lipoprotein cholesterol Ievels declined 25.8 %, total cholesterol levels 20.3%, and triglyceride levels 6.2%, while high-density lipoprotein cholesterol levels remained essentially unch anged. Overall, 72% of pravastatin-treated patients achieved reduction s in low-density lipoprotein cholesterol level in excess of 20%, and 4 4%, attained declines in excess of 30% (both P<.01 vs placebo). Pravas tatin was generally well tolerated in this population, with one patien t (0.5%) exhibiting a reversible myopathy with creatine kinase elevati ons to 10 times the upper limit of normal. No substantial elevations o f aminotransferase levels of two to three times the upper limit of nor mal occurred in either the pravastatin or the placebo group. Drug comp liance was high, exceeding 90%. Conclusion: Pravastatin appears to be an effective and safe lipid-lowering agent and is the first 3-hydroxy- 3-methylglutaryl coenzyme A reductase inhibitor to be studied extensiv ely in this underrepresented population.