Comparison of two regimens of policosanol administered at 20 mg/d in patients with type II hypercholesterolemia:: A randomized, double-blind, placebo-controlled study

Background: Policosanol is a mixture of higher primary aliphatic alcohols purified from sugar cane wax that has demonstrated dose-dependent cholesterol-lowering effects in patients with type II hypercholesterolemia and dyslipidemia associated with non-insulin-dependent diabetes mellitus. The 20 mg/d dosage is particularly useful for patients at high coronary risk and to date this dosage has been administered as two 10-mg tablets once daily. Objective: This 8-week study was undertaken to compare the cholesterol-lowering effects and tolerability of 2 dosing regimens of policosanol 20 mg/d: two 10-mg tablets versus one 20-mg tablet taken once daily with the evening meal. Methods: In this randomized, double-blind. placebo-controlled study, after 4 weeks of dietary stabilization, 62 patients with type II hypercholesterolemia were randomly assigned in a 1:1:1 ratio to receive 2 placebo tablets, 2 policosanol 10-mg tablets, or 1 policosanol 20-mg tablet plus 1 matched placebo tablet. Physical examinations were performed and lipid profiles and blood samples were obtained at baseline and after 4 and 8 weeks of therapy. The incidence of adverse events (AEs) and compliance with study medications were also evaluated at week 4 and week 8 of treatment. Results: The 2 policosanol 20 mg/d regimens were similarly effective. Policosanol administered as two 10-mg tablets significantly reduced total cholesterol (TC) (16.0%, P< 0.001 vs baseline), low-density lipoprotein cholesterol (LDL-C) (35.9%, P< 0.001), as well as the TC:high-density lipoprotein cholesterol (HDL-C) ratio (37.3%, P< 0.001) and LDL-C:HDL-C ratio (52.4%, P< 0.001). The regimen significantly increased HDL-C levels (38.0%, P< 0.001 vs baseline). The 20-mg policosanol tablet also significantly decreased TC (20.0%), LDL-C (37.8%), TC:HDL-C ratio (39.9%), and LDL-C:HDL-C ratio (52.4%) (all P < 0.001), whereas it significantly raised HDL-C levels (39.4%, P < 0.001). Triglyceride levels did not change significantly in either group. The differences between treatment groups were not significant. No significant changes in lipid profile variables were observed in the placebo group. Both policosanol 20 mg/d regimens were well tolerated. No drug-related clinical or blood biochemistry abnormalities were observed after 8 weeks of treatment. Five patients (8.1%) withdrew from the study, 2 from the placebo group, 2 from the 10-mg tablet group, and 1 from the 20-mg tablet group. One of these patients (in the placebo group) withdrew from the study because of an AE (duodenal ulcer). The other AEs reported during the study were mild, and the frequency of AE reports was similar in all the groups. Conclusions: These results demonstrate that policosanol 20 mg/d is an effective and well-tolerated cholesterol-lowering regimen whether administered as a 20-mg tablet once daily or two 10-mg tablets once daily with the evening meal.