Ciprofibrate versus gemfibrozil in the treatment of mixed hyperlipidemias:An open-label, multicenter study

Mixed hyperlipidemia is a common risk factor for cardiovascular disease. Th e aim of this trial was to evaluate the efficacy and safety of ciprofibrate versus gemfibrozil for the treatment of patients with mixed hyperlipidemia carefully selected for similar lipid profiles. A total of 68 patients who had mixed hyperlipidemia after following an isocaloric American Heart Assoc iation (AHA) phase I diet for 4 weeks were included. The plasma lipid level s at the inclusion were low-density lipoprotein-cholesterol (LDL-C) greater than or equal to 130 mg/dL, cholesterol greater than or equal to 240 mg/dL , and triglycerides greater than or equal to 200 mg/dL. Patients were rando mly assigned to receive ciprofibrate 100 mg/d or gemfibrozil 1,200 mg/d. At the end of the 8-week treatment period, efficacy and safety parameters wer e compared with baseline values. The primary efficacy parameters of the stu dy were percentage changes in triglycerides and LDL-C from baseline. After 8 weeks, plasma triglyceride concentrations were decreased by 43.5% and 54% compared with baseline during ciprofibrate and gemfibrozil therapy, respec tively (P < .001). High-density lipoprotein-cholesterol (HDL-C) concentrati ons were increased 20.8% and 19.3% during ciprofibrate and gemfibrozil, res pectively (P < .001). Apoprotein B, cholesterol, and very-low-density lipop rotein-cholesterol (VLDL-C) concentrations were also improved by the study drugs (18.6%, 13.2%, and 30.9%, respectively, during ciprofibrate and 44%, 13.8%, and 14.4%, respectively, during gemfibrozil), Meanwhile, the effect of the drug was minimal on LDL-C. A significant decrease in non-HDL-C resul ted from both treatments (19% and 19.5%, respectively, P < .05). The only s tatistically significant difference observed between treatments was the eff ects on fibrinogen concentration, a coronary risk factor, Ciprofibrate sign ificantly decreased its concentration by 18.8%, fibrinogen was slightly inc reased during gemfibrozil treatment. No patient had a significant modificat ion on any of the safety tests. In summary, ciprofibrate and gemfibrozil ar e well-tolerated and efficacious treatments for mixed hyperlipidemia. Signi ficant reductions in triglycerides, non-HDL-C, and apolipoprotein B were ac hieved with both drugs. A significant fibrinogen reduction was obtained wit h ciprofibrate. Copyright (C) 2001 by W.B. Saunders Company.