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 p urified from sugar cane wax that has demonstrated dose-dependent cholestero l-lowering effects in patients with type II hypercholesterolemia and dyslip idemia associated with non-insulin-dependent diabetes mellitus. The 20 mg/d dosage is particularly useful for patients at high coronary risk and to da te this dosage has been administered as two 10-mg tablets once daily. Objective: This 8-week study was undertaken to compare the cholesterol-lowe ring 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 hypercholesterol emia 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 p lacebo 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 medication s were also evaluated at week 4 and week 8 of treatment. Results: The 2 policosanol 20 mg/d regimens were similarly effective. Polic osanol administered as two 10-mg tablets significantly reduced total choles terol (TC) (16.0%, P< 0.001 vs baseline), low-density lipoprotein cholester ol (LDL-C) (35.9%, P< 0.001), as well as the TC:high-density lipoprotein ch olesterol (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 v s 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 significa nt changes in lipid profile variables were observed in the placebo group. B oth policosanol 20 mg/d regimens were well tolerated. No drug-related clini cal or blood biochemistry abnormalities were observed after 8 weeks of trea tment. Five patients (8.1%) withdrew from the study, 2 from the placebo gro up, 2 from the 10-mg tablet group, and 1 from the 20-mg tablet group. One o f 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 effec tive and well-tolerated cholesterol-lowering regimen whether administered a s a 20-mg tablet once daily or two 10-mg tablets once daily with the evenin g meal.