Articles

Long- term effects of policosanol on older patients with Type 2 diabetes.

Author

Mas R, Castano G, Fernandez J, Gamez RR, Illnait J, Fernandez L, Lopez E, Mesa M, Alvarez E, Mendoza S.

Date

2004

Journal

Asia Pac J Clin Nutr

Abstract

Diabetes and hypercholesterolemia are major coronary risk factors, coronary risk of diabetics being increased as compared with non-diabetics. The main goal of dyslipidemia control in diabetics is to lower elevated low-density lipoprotein-cholesterol (LDL-C) levels. Policosanol is a cholesterol-lowering drug purified from sugar cane wax, which significantly reduces LDL-C levels and inhibits platelet aggregation. Previous short-term studies have shown the efficacy and tolerability of policosanol at 10 mg/day on patients with Type 2 diabetes, but no previous study on the effects of long-term treatment or lower doses has been reported. This study was undertaken to investigate the long-term efficacy, safety and tolerability of policosanol on patients with Type 2 diabetes. After 5 weeks on a step one cholesterol lowering diet, 239 patients with Type 2 diabetes were randomized to policosanol 5 mg/day or placebo for 2 years. Analysis was by Intention-to-treat. Baseline characteristics were well matched in both groups. After one year, policosanol reduced significantly (p < 0.0001 versus baseline and placebo) low-density lipoprotein-cholesterol (LDL-C) (21.1 %), total cholesterol (TC) (17.5 %) and triglycerides (TG) (16.0 %), whereas increased (p <0.01 versus baseline and placebo) high-density lipoprotein-cholesterol (HDL-C) levels (10.7 %). Treatment effects on LDL-C, HDL-C and TC persisted, even moderately enhanced, during the study, the effect on TG being persistent too Thus, at study completion, policosanol lowered (p < 0.0001 vs baseline and placebo) LDL-C (29.5 %), TC (21.9 %), TG (16.9 %) and raised (p < 0.0001 vs baseline and placebo) HDL-C (12.4 %). No significant changes on lipid profile variables of placebo group occurred during the study. Of 239 randomized patients, 63 (26.4 %) discontinued the study, 43/120 placebo (35.8 %) and 20/119 policosanol patients (16.8 %). Of them, 35 patients (28 placebo, 7 policosanol) withdrew from the study due to some AE. The frequency of serious adverse events (SAE), most vascular, in policosanol patients (6/119, 5.0 %) was lower than in respective placebo (26/120, 43.3 %). Five patients, all placebo, died during the study, four of them due to myocardial infarction. No drug-related impairment of safety indicators, particularly on glycemic control, was observed. Nevertheless, a reduction of systolic and diastolic blood pressure was observed in policosanol patients compared with placebo. The overall frequency of policosanol patients reporting mild and/or moderate was similar than in placebo. It is concluded that policosanol was long-term effective, safe and well tolerated on patients with dyslipidemia due to Type 2 diabetes.