Food Chem Toxicol 1995 Jul;33(7):573-8. Carcinogenicity of policosanol in mice: an 18-month study. Aleman CL, Puig MN, Elias EC, Ortega CH, Guerra IR, Ferreiro RM, Brinis F. Center of Natural Products, National Center for Scientific Research, Havana City, Cuba.
Policosanol (trade name Ateromixol) is a new cholesterol-lowering drug that has been isolated and purified from sugar cane wax. The effects of policosanol (50-500 mg/kg) administered orally for 18 months to male and female Swiss mice were investigated. No differences in daily clinical observations, weight gain, food consumption and mortality (survival analysis) between groups were found. Histopathological study showed that the frequency of neoplastic (benign and malignant) lesions was similar in the control and policosanol-treated groups. The lesions observed were similar to the spontaneous lesions in Swiss mice reported in previous studies. As no drug-related increase in the occurrence of malignant or benign neoplasm was found, nor acceleration in tumour growth in any specific group observed, this study shows no evidence of policosanol-induced carcinogenicity in Swiss mice.
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J Pharm Pharmacol 1995 Apr;47(4):289-91. Effect of policosanol on lipofundin-induced atherosclerotic lesions in rats. Noa M, Mas R, de la Rosa MC, Magraner J. National Center for Scientific Research, Havana, Cuba.
Policosanol is a mixture of higher aliphatic alcohols isolated from sugar cane wax, showing cholesterol-lowering effects and preventing the development of lipofundin-induced lesions in New Zealand rabbits. This study was conducted to determine whether policosanol orally administered to rats also protects against the development of lipofundin-induced atherosclerotic lesions. Fifty four male Wistar rats were randomly distributed amongst a negative control group, a positive control group intravenously injected with lipofundin for eight days, and four experimental groups also injected with lipofundin, but orally receiving policosanol at 0.5, 2.5, 5 and 25 mg kg-1, respectively. Policosanol treatment was orally administered once-a-day for eight days, while control groups similarly received equivalent amounts of vehicle. A significant reduction of the atherosclerotic lesions in the treated animals was observed. It is concluded that policosanol has a protective effect on lipofundin-induced aortic lesions in Wistar rats.
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Diabetes Care 1995 Mar;18(3):393-7. Treatment of hypercholesterolemia in NIDDM with policosanol. Torres O, Agramonte AJ, Illnait J, Mas Ferreiro R, Fernandez L, Fernandez JC. Julio Trigo Hospital, Havana, Cuba.
OBJECTIVE--To determine whether elevated levels of cholesterol and low-density lipoprotein (LDL) cholesterol in non-insulin-dependent diabetes mellitus (NIDDM) patients could be decreased by policosanol, a new cholesterol-lowering drug. NIDDM predisposes patients to coronary artery disease (CAD) through the direct action of hyperglycemia on the arteries as well as the dyslipidemia induced by NIDDM. RESEARCH DESIGN AND METHODS--This double-blind placebo-controlled trial was performed in 29 patients with NIDDM and hypercholesterolemia. After stable glycemic control was achieved by diet and/or oral hypoglycemic drugs, patients were instructed to follow a cholesterol-lowering diet for 6 weeks. Patients who met entry criteria received, under double-blind conditions, policosanol (5 mg) or placebo tablets twice a day for 12 weeks. RESULTS--Policosanol (10 mg/day) significantly reduced total cholesterol by 17.5% and LDL cholesterol by 21.8% compared with baseline and placebo. Furthermore, high-density lipoprotein (HDL) cholesterol was raised by 11.3% (not significant), and triglycerides showed a statistically nonsignificant decrease of 6.6%. These changes in lipid profile were similar to those induced by policosanol in nondiabetic patients with type II hyperlipoproteinemia. CONCLUSIONS--Glycemic control was unaffected by treatment. No clinically or biochemically adverse effects attributable to treatment were observed. Only one patient (placebo) withdrew from the trial because of an adverse experience (erythema). We concluded that policosanol is effective and safe in patients with NIDDM and hypercholesterolemia.
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Int J Clin Pharmacol Res 1995;15(4):159-65. A two-year study on the efficacy and tolerability of policosanol in patients with type II hyperlipoproteinaemia. Canetti M, Moreira M, Mas R, Illnait J, Fernandez L, Fernandez J, Diaz E, Castano G. "Salvador Allende" Hospital, Havana, Cuba.
This is a report of the results of a two years' randomized, double-blind placebo-controlled study of the efficacy, safety, and tolerability of policosanol administered at 5 mg twice-a-day in the treatment of type II hyperlipoproteinaemia. The study included 69 patients from both sexes, in whom total cholesterol and low-density-lipoprotein cholesterol (LDL-C) were not controlled sufficiently by diet. The treatment effect on total cholesterol and LDL-C was maintained during the 2-year follow up. Thus, percent reductions 24 months after therapy were 25% (LDL-C) and 18% (cholesterol). All comparisons with placebo were significant. Similarly, ratios of LDL-C to HDL-C and cholesterol to HDL-C were significantly reduced and such decreases were maintained during the study. Policosanol raised significantly the values of high-density lipoprotein cholesterol (HDL-C) during the study and maximal increases were reached 12 months after therapy (+21%). From this time the increases mildly declined to +14% and +11.2% respectively at 18 and 24 months after therapy. No significant changes in triglycerides were observed as compared with baseline or placebo. No patient withdrew from the study because of adverse effects. No drug-related clinical or biochemical adverse side-effects were observed. Any adverse experiences reported were mild and transient; moreover, no significant differences were obtained when compared with those reported by the placebo group. The results indicate that policosanol administered for two years to patients with type II hypercholesterolaemia shows a maintained efficacy as well as very good safety and tolerability.
