Efficacy and tolerability of simvastatin 20 mg vs pravastatin 20 mg in patients with primary hypercholesterolemia. European Study Group.

The safety, tolerability, and efficacy of 20 mg daily doses of simvastatin and pravastatin were compared in this double-blind, randomized trial of 210 patients with primary hypercholesterolemia. Simvastatin was found to produce significantly greater mean percent reductions from baseline in total cholesterol (28% versus 21%), LDL cholesterol (38% versus 29%), and apolipoprotein B concentrations (25% versus 17%) than did pravastatin, and a greater percentage of patients receiving simvastatin (94% versus 80%) had at least a 20% reduction in LDL cholesterol. Both simvastatin and pravastatin produced similar significant mean percent reductions from baseline in triglyceride concentrations (14% and 11%) and significant mean percent increases in the concentrations of HDL cholesterol (7% for both) and apolipoprotein A-I (4% for both). Resulting reductions in the ratios of total cholesterol: HDL cholesterol, LDL cholesterol: HDL cholesterol, and apolipoprotein B: apolipoprotein A-I were significantly greater in the simvastatin group. Both simvastatin and pravastatin were well tolerated. The incidence and severity of clinical and laboratory adverse experiences were similar in both groups, and none were classified as serious. The results of this study confirm the results of prior studies that have found simvastatin to produce lipid-lowering effects superior to those of pravastatin when administered at equivalent mg doses, while demonstrating similar safety profiles.

RCT Entities:   Population Interventions Outcomes