COMPARATIVE-STUDY OF THE EFFICACY AND TOLERABILITY OF SIMVASTATIN AND PRAVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

The efficacy, safety and tolerability of simvastatin 10 mg/day and pravastatin 20 mg/day were compared in this multinational double-blind randomised parallel trial involving 273 patients with primary hypercholesterolaemia [total cholesterol greater than or equal to 6.5 mmol/L (greater than or equal to 250 mg/dl)]. Patients started or continued a standard lipid-lowering diet for greater than or equal to 6 weeks prior to entering a 4-week, placebo baseline period. Following this period, patients with demonstrated hypercholesterolaemia were randomised to once-daily treatment with simvastatin 10mg (n = 137) or pravastatin 20mg (n = 136) for 6 weeks. Simvastatin treatment was associated with significantly (p < 0.01) greater reductions in plasma total and low density lipoprotein (LDL) cholesterol (21 and 28%, respectively) compared with pravastatin (18 and 25%, respectively). The percentage of patients achieving a desirable LDL cholesterol level of < 3.4 mmol/L (< 130 mg/dl) was higher in the simvastatin (22%) than in the pravastatin group (16%), although the difference did not reach statistical significance (p = 0.28). Both treatments were associated with modest elevations (6%) in high density lipoprotein cholesterol concentrations and reductions (13 to 14%) in plasma triglyceride concentrations. Treatment-related clinical adverse events were few and similar for both drugs. Two patients in each group were withdrawn from the study because of adverse events. No clinically significant change in any laboratory parameter was apparent. When administered at half the daily dose of pravastatin, simvastatin 10mg had a significantly greater lipid-lowering effect and an equivalent safety profile.