Abstract

Policosanol is a new cholesterol-lowering drug that is purified from sugarcane wax. The present study investigated the long-term efficacy and tolerability of policosanol in patients with primary hypercholesterolemia. Eighty-five patients who participated in a previous double-masked, placebo-controlled study were given policosanol (10 mg/d) in a 3-year open-extension period. The duration of the policosanol treatment was 5 years for those patients who had previously received policosanol (n = 42) and 3 years for those previously treated with placebo (n = 43). Efficacy was maintained during the entire treatment period. Policosanol significantly lowered cholesterol levels in both groups, compared with pretreatment, baseline values, by 20% in the group receiving policosanol for the entire 5 years, and by 17% in those receiving policosanol for 3 years (previously receiving placebo). Five patients withdrew from the study, none because of adverse events. No drug-related disturbances were observed in the safety indicators. This long-term study shows that policosanol is both effective and well tolerated, which is in agreement with results of previous short- and long-term trials.

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