ONE-YEAR EFFICACY AND SAFETY OF POLICOSANOL INPATIENTS WITH TYPE-II HYPERCHOLESTEROLEMIA

A 12-month, double-blind, placebo-controlled study was conducted in patients with type II hypercholesterolemia to ascertain the efficacy, safety, and tolerability of policosanol (5 mg once daily). After adhering to a cholesterol-lowering diet for 12 weeks, 59 patients were randomized to receive either placebo or policosanol (5 mg) tablets for 12 months. Tablets were taken once daily before the evening meal. Two months after the start of therapy, policosanol had significantly reduced total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels. These changes were maintained, or increased, throughout the study. After 12 months, total cholesterol levels had decreased by 15.3% and LDL-C by 23.7%. In the placebo group a significant increase in both values was detected 9 months after the start of therapy. No significant changes in triglycerides and high-density lipoprotein cholesterol (HDL-C) were reported compared with baseline or placebo. LDL-C:HDL-C and cholesterol:HDL-C ratios were significantly reduced in the policosanol-treated group: decreases were 25.3% (LDL-C:NDL-C) and 17.0% (cholesterol:HDL-C) after 12 months. Of the seven patients who discontinued the trial (five from the placebo group and two from the policosanol group), only one (placebo group) withdrew because of side effects. The adverse effects reported were mild and transient; no significant differences were seen in the treated patients compared with those receiving placebo. No drug-related clinical, biochemical, or ophthalmologic adverse effects were observed. The study indicates that policosanol 5 mg administered once daily for 12 months results in maintained efficacy as well as good safety and tolerability in patients with type II hypercholesterolemia.