Comparison of simvastatin and ciprofibrate in the treatment of primary hypercholesterolaemia — a French multicentre study

Abstract

The efficacy and safety of simvastatin, 10–40 mg/day, were compared with ciprofibrate, 100 mg/day, in patients with primary hypercholesterolaemia. The study consisted of a 4-week placebo period followed by an 18-week double-blind treatment period (initial total plasma cholesterol levels ≥ 6.45 mmol/l (250 mg/dl)). Eighty-two patients were assigned to each treatment group. Patients assigned to the simvastatin group received an initial dose of 10 mg/day. In patients whose total cholesterol was greater than 5.2 mmol/1 (200 mg/dl) at the end of 6 weeks, the dose of simvastatin was increased to 20 mg for another 6-week period. After 12 weeks' treatment, the dose was further increased to 40 mg/day in patients whose total cholesterol remained above 5.2 mmol/l. By week 18, simvastatin had reduced total cholesterol, low density lipoprotein (LDL)-cholesterol, apolipoprotein (apo) B and triglycerides by 29.5%, 40.7%, 26.8% and 11.4%, respectively. With ciprofibrate, the corresponding reductions were 15.5%, 19.8%, 16.9% and 33.9%, respectively. The mean percentage increases in high density lipoprotein (HDL)-cholesterol were significant and similar in each treatment group after 18 weeks (8.2% with simvastatin, 9.7% with ciprofibrate). However, the mean percentage reductions from baseline in total cholesterol and LDL-cholesterol were significantly larger in the simvastatin group than in the ciprofibrate group at weeks 6, 12 and 18 (P ⩽ 0.01). By contrast, the reduction in total triglycerides was smaller with simvastatin than with ciprofibrate. Overall, the frequency of adverse events was similar in both treatment groups. Moreover, the effects of simvastatin on total and LDL-cholesterol are greater than those of ciprofibrate, regardless of the levels of total cholesterol and triglycerides prior to treatment.