EFFICACY AND TOLERABILITY OF POLICOSANOL IN ELDERLY PATIENTS WITH TYPE-II HYPERCHOLESTEROLEMIA - A 12-MONTH STUDY

This study reports the results of a 12-month, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of policosanol at daily doses of 10 mg in the treatment of elderly patients with type II hypercholesterolemia. The study included 62 elderly patients of both sexes with total cholesterol and low-density lipoprotein cholesterol (LDL-C) not controlled sufficiently during a diet-only period. Two months after therapy, policosanol significantly (P < 0.001) reduced total cholesterol and LDL-C. The treatment effect on cholesterol, and ratios of LDL-C:HDL-C and total cholesterol: HDL-C was shown not to wear off during the 12-month follow-up, Percent reductions were maintained, or even increased, 12 months after therapy by 23.1% (LDL-C), 15.6% (total cholesterol), 25.2% (LDL-C:HDL-C), and 19% (total cholesterol:HDL-C) (P < 0.00001), All lipid profile variables remained unchanged in the placebo group throughout the entire study, At the end of the treatment period, HDL-C was increased by 8%, Triglycerides were not significantly changed. Only two patients, both in the placebo group, withdrew from the study, but neither did so because of adverse effects, No drug-related clinical or biochemical adverse effects were observed, Adverse effects reported were mild and transient, and no significant differences were seen when compared with those reported by the placebo group. Our results indicate that policosanol administered at 10 mg/d for 12 months shows a maintained efficacy, and very good safety and tolerability in elderly patients with hypercholesterolemia.