Effects of rice policosanol on serum lipoproteins, homocysteine, fibrinogen and C-reactive protein in hypercholesterolaemic patients.
Policosanol is an agent that includes mixtures of aliphatic primary alcohols extracted primarily from sugar-cane wax. This mixture has been shown to lower total and low-density lipoprotein (LDL) cholesterol in animal models, healthy volunteers and hypercholesterolaemic patients. This study investigated the efficacy and tolerability of rice policosanol (Oryza sp.) 10 mg/day in 70 hypercholesterolaemic patients of both sexes aged 20-78 years in a randomised, double-blind, crossover, placebo-controlled, single-centre trial. After an 8-week run-in period during which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, they were randomly assigned to receive rice policosanol 10mg tablets or placebo tablets once daily with the evening meal for 8 weeks. During the next 8 weeks those patients who received policosanol during the first 8 weeks received placebo, and those who received placebo during the first 8 weeks, received policosanol. Total, LDL, high-density lipoprotein (HDL), HDL2 and HDL3 cholesterol, triglycerides, oxidised LDL (ox-LDL), apoproteins (Apos) AI and B, lipoprotein (a) [Lp(a)], fibrinogen, homocysteine and C-reactive protein (CRP) levels were measured. Rice policosanol significantly reduced plasma total cholesterol from 7.37 +/- 1.42 mmol/L to 6.99 +/- 1.33 mmol/L (p = 0.007) and increased Apo AI from 1.49 +/- 0.39 mmol/L to 1.58 +/- 0.38 mmol/L (p = 0.037) but did not change plasma triglycerides, HDL, HDL2, HDL3 and LDL cholesterol, ox-LDL, Lp(a), Apo B, fibrinogen, homocysteine or CRP levels. Rice policosanol 10 mg/day moderately decreased plasma total cholesterol and increased Apo AI. Rice policosanol was also well tolerated, with no drug-related effects on safety parameters such as serum aminotransferases and creatine phosphokinase detected or found on physical examination.