Long-term effects of policosanol on obese patients with Type II Hypercholesterolemia.

Both hypercholesterolemia (HC) and obesity are coronary risk factors. Clinical studies have shown the benefits of lowering elevated plasma levels of low-density lipoprotein-cholesterol (LDL-C) on clinical end-points. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic range from 5 to 20 mg/day. This randomised, double-blinded, placebo-controlled study was undertaken to investigate the long-term efficacy and safety of policosanol in obese patients (BMI = 30) with Type II hypercholesterolemia. After 5 weeks on step one cholesterol-lowering diet, 129 patients were randomised to policosanol 5 mg or placebo tablets taken once daily with the evening meal for 3 years. Lipid profile variables, safety indicators, adverse events (AE) and compliance with diet counselling and study medications were assessed. Study patiens showed a high frequency of other coronary risk factors, hypertension being the most common. Both groups were well matched at randomisation. After one year on treatment, policosanol significantly (p < 0.01 vs placebo) lowered serum LDL-C, the primary efficacy variable (24.3 %) and total cholesterol (TC) (15.8 %), whereas increased high-density lipoprotein-cholesterol (HDL-C) (21.9 %). Changes of lipid variables in placebo were not significant. Treatment effects were persistent, even slightly enhanced, during the trial. At study completion, policosanol had lowered (p < 0.00001) LDL-C (31.8 %) and TC (20.1 %), while markedly raised (p <0.00001) HDL-C (24.6 %). Thirty patients (18 placebo, 12 policosanol) discontinued the study: 15 (11 placebo, 4 policosanol) due to AE and 12 (9 placebo, 3 policosanol) due to serious adverse events (SAE), most vascular. Policosanol was safe and well tolerated, not impairing significantly any safety indicator. Average body weight was slightly reduced over the study, indicating a general acceptable compliance with dietary recommendations, but policosanol did not show any drug effect on body weight. Overall, 28 placebo and 26 policosanol patients reported some mild or moderate AE during the study. It is concluded that policosanol was effective for lowering cholesterol in obese patients with type II hypercholesterolemia, being also safe and well tolerated. [ABSTRACT FROM AUTHOR]