Effects of bezafibrate plus policosanol or placebo in patients with combined dyslipidemia:: A pilot study

Objective: The goal of this randomized, double-blind, clinical pilot study was to compare the efficacy and tolerability of the combination therapy bezafibrate plus policosanol versus bezafibrate plus placebo in patients with combined dyslipidemia. Methods: After 6 weeks of a standard lipid-lowering diet, 29 patients were assigned randomly to receive, under double-blind conditions, bezafibrate 400 mg/d plus policosanol 10 mg/d or bezafibrate 400 mg/d plus placebo. Treatments were taken once daily with the evening meal for 8 weeks. Results: Bezafibrate plus policosanol significantly reduced levels of total cholesterol (TC) (20.8%; P < 0.001), low-density lipoprotein cholesterol (LDL-C) (27.7%; P < 0.001), triglycerides (30.2%; P < 0.001), and the atherogenic ratios of LDL-C to high-density lipoprotein cholesterol (HDL-C) (36.8%) and TC to HDL-C (29.8%). Bezafibrate plus placebo significantly lowered levels of TC (9.2%; P < 0.05), LDL-C (10.7%; P < 0.05), triglycerides (29.2%; P < 0.001), and both atherogenic ratios (LDL-C to HDL-C [13.3%] and TC to HDL-C [13.8%][P < 0.05]). Levels of HDL-C increased significantly in both groups (by 14.5% [P < 0.01] after bezafibrate plus policosanol therapy and by 8.0% [P < 0.05] after bezafibrate plus placebo therapy). Between-group comparisons showed that: percentage reductions of TC, LDL-C, HDL-C, and atherogenic indices were significantly larger in the bezafibrate plus policosanol group than in the bezafibrate plus placebo group. None of the other between-group differences were significant. There were no drug-related effects on safety indicators. The combination of bezafibrate and policosanol was very well tolerated. No patient discontinued the study because of adverse effects and only 1 patient who was receiving bezafibrate plus placebo reported a mild adverse effect (skin dryness) during the study. Conclusions: We concluded that the coadministration of policosanol and bezafibrate combined the benefits of both drugs on patients' lipid profiles and that the safety and tolerability of this combination was very good. Further clinical studies using larger sample sizes must be conducted to corroborate these results.