Effects of Policosanol in Patients With Metabolic Syndrome: A Six-Month Study

Background: The metabolic syndrome comprises a set of cardiovascular risk factors represented by obesity of central distribution, dyslipidemias, glucose metabolism abnormalities and arterial hypertension, closely associated with insulin resistance. Policosanol is a mixture of high molecular weight alcohols purified from sugar cane wax with cholesterol-lowering and antioxidant effects. The aim of this study is to investigate in the medium term the effects of policosanol in patients with metabolic syndrome, as well as its safety and tolerability. Methods: This phase IV study had a double-blind, randomized and controlled design, with two parallel groups that received policosanol (10 mg/day) or placebo for 6 months. The study included patients with metabolic syndrome, of both sexes, aged between 25 and 70 years. As a primary efficacy variable, the effects on oxidative stress were evaluated, while the effects on lipids profile variables were considered as a secondary efficacy variable. Statistical analysis of the data was performed according to the intention-to-treat method. Results: The study included 100 patients with metabolic syndrome (81 men, 19 women) (average age: 51 years). At the end of 6 months of treatment, policosanol significantly reduced the redox index with respect to the initial values and with respect to the placebo group. Policosanol significantly reduced levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), 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; it did not affect the physical and laboratory parameters investigated, with the exception of a significant and favorable reduction in the levels of apolipoprotein (Apo) B. Conclusions: It is concluded that policosanol therapy for 6 months produces improvements on oxidative stress in patients with metabolic syndrome, in addition to a beneficial effect on their lipid profile, being safe and well tolerated.