Efficacy and tolerability of policosanol (25 mg/day) in patients with Type II Hyperlipoproteinemia

Policosanol is a mixture of high molecular weight alcohols purified from sugar cane wax with cholesterol-lowering effects and relevant pleiotropic effects, such as the inhibition of platelet aggregation and the susceptibility of low-density lipoprotein (LDL) to be oxidised. The study was undertaken to investigate the effects of policosanol (25 mg/d) in patients with type II hyperlipoproteinemia as well as its safety and tolerability. This study had a double-blind, randomized, controlled, design with two parallel groups that received policosanol (25 mg/d) or placebo for 12 weeks. The study included patients with type II hyperlipoproteinemia, of both sexes, aged between 25 and 70 years. As a primary efficacy variable, the effects on LDL-cholesterol (LDL-C) were evaluated. Statistical analysis was performed according to the Intention to treat method. The study included 63 patients (27 men, 36 women) (average age: 56 years). At the end of treatment, policosanol significantly reduced levels of LDL-C and total cholesterol, as well as increased serum levels of high-density lipoprotein-cholesterol     (HDL-C), while triglyceride levels although reduced at the end of treatment, this reduction was not significant. The policosanol was safe and well tolerate, not affecting the physical and laboratory parameters investigated. It is concluded that although treatment with Policosanol            (25 mg/d) produced beneficial effects on the lipid profile in these patients at 12 weeks, in addition to being safe and well tolerated, it is not justified to indicate this dose, due to obtaining results lower than those obtained with the 20 mg/d dose in a shorter treatment time.