Effects of policosanol and lovastatin in patients with intermittent claudication: a double-blind comparative pilot study.

Castaño G, Más R, Fernández L, Gámez R, Illnait J

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

Angiology 2003 Jan; 54(1):25-38.

Anti-Platelet Effects of Policosanol:
Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers.

Anti-Platelet Effects of Policosanol

Arruzazabala M. L., Carbajal D., Mas R. and Valdes S. (1997): Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers.

Policosanol reduces platelet aggregation by altering prostaglandin synthesis. Specifically, policosanol lowers serum levels of the pro-aggregatory thromboxane A2, while increasing the anti-aggregatory prostaglandin prostacyclin. Clinical trials in humans have shown that policosanol significantly inhibits platelet aggregation without affecting coagulation parameters.9-11 Policosanol’s effects on platelet aggregation compare quite favorably to low-dose aspirin

Pharmacol Res 36(4):293-7.

Effects of rice policosanol on serum lipoproteins, homocysteine, fibrinogen and C-reactive protein in hypercholesterolaemic patients.

Department of Internal Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.

BACKGROUND: 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.

PATIENTS AND METHODS: 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. RESULTS: 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.

CONCLUSION: 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.