EFFECTS OF POLICOSANOL ON HYPERCHOLESTEROLEMIC PATIENTS WITH ABNORMALSERUM BIOCHEMICAL INDICATORS OF HEPATIC-FUNCTION

Forty-six patients with primary hypercholesterolemia and abnormal seru m biochemical indicators of hepatic function were included in a 12-wee k, randomized, double-masked, placebo-controlled study of the efficacy and tolerability of policosanol 5 or 10 mg/d. Patients followed a sta ndard cholesterol-lowering diet for at least 6 weeks and were then ran domized to receive policosanol or placebo tablets, All groups were sta tistically similar at randomization, The study of the 5-mg dose compri sed 24 patients. In this study, policosanol significantly reduced tota l cholesterol (13.6%), low-density lipoprotein cholesterol (LDL-C) (19 .1%), and the ratios of cholesterol:high-density lipoprotein cholester ol (HDL-C) (21.1%) and LDL-C:HDL-C (25.5%). HDL-C increased significan tly by 11.5%, while triglycerides did not change significantly, The st udy 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 l evels (17.9%) tended toward significance, while the changes in triglyc eride levels were not significant, The lipid profile of the placebo gr oup was not changed significantly; no clinical, biochemical, or hemato logic adverse effects were observed; and the liver function indicators that were abnormal at baseline had not deteriorated further. No patie nt withdrew from the study because of adverse events, Seven patients ( four from the placebo group and three from the policosanol group) repo rted at least one adverse experience, all of which were mild and trans ient, The comparisons between groups did not show any significant diff erences, The results demonstrate that policosanol is effective and wel l tolerated in patients with type II hypercholesterolemia and abnormal serum biochemical indicators of hepatic function.