Effects of policosanol on hypercholesterolemic patients with abnormal serum biochemical indicators of hepatic function

Abstract

Forty-six patients with primary hypercholesterolemia and abnormal serum biochemical indicators of hepatic function were included in a 12-week, randomized, double-masked, placebo-controlled study of the efficacy and tolerability of policosanol 5 or 10 mg/d. Patients followed a standard cholesterol-lowering diet for at least 6 weeks and were then randomized to receive policosanol or placebo tablets. All groups were statistically similar at randomization. The study of the 5-mg dose comprised 24 patients. In this study, policosanol significantly reduced total cholesterol (13.6%), low-density lipoprotein cholesterol (LDL-C) (19.1%), and the ratios of cholesterol:high-density lipoprotein cholesterol (HDL-C) (21.1%) and LDL-C:HDL-C (25.5%). HDL-C increased significantly by 11.5%, while triglycerides did not change significantly. The study of the 10-mg dose comprised 22 patients. Policosanol significantly lowered total cholesterol (15.4%), LDL-C (22.3%), and the cholesterol:HDL-C (26.1%) and LDL-C:HDL-C (32.2%) ratios. The increase in HDL-C levels (17.9%) tended toward significance, while the changes in triglyceride levels were not significant. The lipid profile of the placebo group was not changed significantly; no clinical, biochemical, or hematologic adverse effects were observed; and the liver function indicators that were abnormal at baseline had not deteriorated further. No patient withdrew from the study because of adverse events. Seven patients (four from the placebo group and three from the policosanol group) reported at least one adverse experience, all of which were mild and transient. The comparisons between groups did not show any significant differences. The results demonstrate that policosanol is effective and well tolerated in patients with type II hypercholesterolemia and abnormal serum biochemical indicators of hepatic function.