Comparative effects of two once-daily regimens of policosanol in patients with type II hypercholesterolemia

Abstract

This randomized, double-masked, placebo-controlled study compares the effects of two different dosage schedules of policosanol administered at 10 mg/d—two 5-mg tablets versus one 10-mg tablet taken once a day with the evening meal for 10 weeks. After 4 weeks on a step one cholesterol-lowering diet, 60 patients with type II hypercholesterolemia were randomly assigned to receive either two policosanol 5-mg tablets, one policosanol 10-mg tablet and one matched placebo tablet, or two placebo tablets. Both regimens were similarly effective. Two 5-mg tablets of policosanol significantly reduced total cholesterol (14.1%), low-density lipoprotein cholesterol (LDL-C) (21.1%), and the ratios of total cholesterol to high-density lipoprotein cholesterol (HDL-C) (22.8%) and LDL-C to HDL-C (27.9%). One 10-mg tablet of policosanol also significantly decreased total cholesterol (14.6%), LDL-C (23.2%), and the ratios of total cholesterol to HDL-C (29.5%) and LDL-C to HDL-C (35.8%). HDL-C levels were significantly raised in both treated groups (17.9% and 28.9%, respectively). Triglycerides did not significantly change in any group. Differences between treated groups were not significant. The placebo group did not show significant changes on lipid profile variables. Both policosanol schedules were well tolerated. No drug-related clinical or blood biochemistry disturbances were produced. Two patients withdrew from the study—one taking placebo and the other receiving two 5-mg tablets of policosanol. The patient on placebo withdrew because of an adverse experience (pruritus); no other adverse experiences were reported during the study. These results demonstrate that policosanol administered once daily with the evening meal as a 10-mg tablet is equivalent to taking two 5-mg tablets at the same time.