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

A 12-month, double-blind, placebo-controlled study was conducted in pa tients with type II hypercholesterolemia to ascertain the efficacy, sa fety, and tolerability of policosanol (5 mg once daily). After adherin g to a cholesterol-lowering diet for 12 weeks, 59 patients were random ized to receive either placebo or policosanol (5 mg) tablets for 12 mo nths. Tablets were taken once daily before the evening meal. Two month s after the start of therapy, policosanol had significantly reduced to tal cholesterol and low-density lipoprotein cholesterol (LDL-C) levels . These changes were maintained, or increased, throughout the study. A fter 12 months, total cholesterol levels had decreased by 15.3% and LD L-C by 23.7%. In the placebo group a significant increase in both valu es was detected 9 months after the start of therapy. No significant ch anges in triglycerides and high-density lipoprotein cholesterol (HDL-C ) were reported compared with baseline or placebo. LDL-C:HDL-C and cho lesterol:HDL-C ratios were significantly reduced in the policosanol-tr eated 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 tr ial (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 placeb o. No drug-related clinical, biochemical, or ophthalmologic adverse ef fects were observed. The study indicates that policosanol 5 mg adminis tered once daily for 12 months results in maintained efficacy as well as good safety and tolerability in patients with type II hypercholeste rolemia.