Low-dose (5 mg) simvastatin versus gemfibrozil in the treatment of primary moderate hypercholesterolemia: Results of a belgian multicenter study

Abstract

A multicenter Belgian study was conducted to compare the safety, tolerability, and effectiveness of simvastatin 5 mg/day and gemfibrozil 1200 mg/day in patients with primary moderate hypercholesterolemia. Thirty-one investigators in 30 sites participated in this study consisting of a 4-week washout period followed by a 6-week open-label treatment period. One hundred ninety-nine patients (144 with type IIa hyperlipidemia [triglycerides ⩽200 mg/dl] and 55 with type IIb hyperlipidemia [triglycerides >200 mg/dl]) were evaluated. Patients were eligible for inclusion if their total cholesterol was ⩾250 mg/dl and ⩽300 mg/dl after the washout period. The evaluation of efficacy was based on percentage changes in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), TC/HDL-C ratio, LDL-C/HDL-C ratio, and total triglycerides. Clinical safety was assessed by evaluating the rate of spontaneous adverse experiences and by measuring blood pressure, pulse rate, and body weight. Adverse laboratory values were also evaluated. The mean percent changes from baseline at week 6 were −17.8% in the simvastatin group versus −10.5% in the gemfibrozil group ( P < 0.01) for total cholesterol, −26% in the simvastatin group versus −11.8% in the gemfibrozil group ( P < 0.01) for LDL-C, +10.2% in the simvastatin group versus +16.2% in the gemfibrozil group (not significant [NS]) for HDL-C, and −13.9% in the simvastatin group versus −32% in the gemfibrozil group ( P < 0.01) for total triglycerides. Simvastatin 5 mg reduced TC, LDL-C, the LDL-C/HDL-C ratio, and the TC/HDL-C ratio more than gemfibrozil. The effect of gemfibrozil on total triglycerides and on HDL-C was larger than that of simvastatin 5 mg. No firm conclusions could be drawn from subgroup analyses because of the limited sample size. Both drugs were well tolerated. The treatment groups were similar with respect to the proportion of patients with clinical and laboratory adverse experiences (11 in the simvastatin group versus 17 in the gemfibrozil group—NS). Due to the efficacy and lack of side effects of simvastatin, the use of simvastatin at a starting dose of 5 mg/day can be recommended in a majority of patients with moderate hypercholesterolemia if diet modification has proved to be ineffective.