This study reports the results of a 12-month, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, and tolerability of policosanol (5 mg twice daily) in patients with type II hypercholesterolemia. After a low-fat, low-cholesterol diet for at least 12 weeks, 74 patients were randomized to receive placebo or policosanol (5 mg) tablets for 12 months. Tablets were taken twice daily before the morning and evening meals. Lipid profile and safety indicators were controlled regularly throughout the study. Significant reductions of serum total cholesterol and low-density lipoprotein cholesterol (LDL-C) were achieved after 2 months of therapy. The treatment effect continued during the 12-month follow-up. After 12 months, total cholesterol had decreased by 17.2% and LDL-C by 26.4%. Similarly, ratios of LDL-C to high-density lipoprotein cholesterol (HDL-C) and total cholesterol to HDL-C were also significantly reduced in the policosanol group, decreasing by 33.3% (LDL-C:HDL-C) and 25.3% (cholesterol:HDL-C) after 12 months. In addition, a significant, sustained increase in HDL-C of 13% to 15% occurred in the policosanol-treated group. No significant changes in triglycerides were observed compared with baseline or placebo. Nine patients discontinued the trial (five from the placebo group and four from the policosanol group), none of them because of adverse effects. The adverse experiences reported were mild and transient. No significant differences were obtained compared with those reported by the placebo group. No drug-related clinical or biochemical adverse effects were detected. It is concluded that policosanol. administered at 5 mg twice daily for 12 months shows a persistent efficacy and is safe and well tolerated in patients with type II hypercholesterolemia.
