Policosanol is a mixture of essential alcohols isolated from sugar cane wax (13). The main constituents are octacosanol, eicosanol, tetracosanol, hexacosanol and triacontanol. There is a significant body of evidence demonstrating the benefits of policosanol with respect to cardiovascular disease. However, the exact method of action is still unknown.
Method of Action
One research group proposed that policosanol was able to reduce endothelial damage by inhibiting the production of foam cells. Foam cells are macrophages that can migrate into the endothelium of the blood vessels and contribute to atherosclerotic plaque formation. Other researchers believe policosanol has a modulating effect on HMG-CoA reductase, the rate-controlling enzyme in cholesterol biosynthesis, but the precise mechanism remains unclear. Still, other investigators believe policosanol may inhibit cholesterol synthesis in the liver at a step before mevalonate production, but total inhibition of the HMG-CoA reductase is doubtful. More recent work suggests policosanol inhibits LDL cholesterol oxidation. This was revealed when markers of peroxidation, such as thiobarbituric acid reactive substances (TBARS), and malondialdehyde (MDA) were lower in the cultures treated with policosanol.
Policosanol has shown the ability to reduce cholesterol levels. In 1994 a randomized, double-blind, placebo-controlled study was conducted on 22 patients with hypercholesterolemia. After eight weeks the patients taking policosanol had a marked reduction in total cholesterol and LDL cholesterol. A similar double-blind, placebo-controlled study was performed on 69 patients, with comparable results. The group of patients taking 10mg of policosanol daily for two years had an 18% reduction in total cholesterol and a 25% reduction in LDL cholesterol. Notably, after 12 months, the so-called good HDL cholesterol was elevated by 21%.
A follow up study was performed on a larger patient group. 437 patients were randomized to receive, under double-blind conditions, policosanol or placebo once a day. After twelve weeks, patients receiving policosanol had a 25% reduction in LDL cholesterol, a 17% reduction in total cholesterol, and a 28% increase in HDL cholesterol (23). The placebo group did not achieve any benefits. Policosanol seems to be effective at lowering cholesterol on both men and women, and all age groups. A study on 179 older aged people resulted in a reduction in total cholesterol and LDL cholesterol by 13% and 16% respectively (24). Also on a positive note there was a 14% increase in HDL cholesterol and a 28% reduction in the total cholesterol to HDL ratio.
Researchers have discovered the benefits of Policosanol in patients experiencing intermittent claudication and platelet aggregation. Early animal studies demonstrated that policosanol reduced platelet aggregation by inhibiting the inflammatory mediator thromboxane B2. More recent human studies revealed the same positive effects. Randomized, double-blind, placebo-controlled trials investigating the effects of policosanol on platelet aggregation found that patients receiving policosanol had significantly less platelet aggregation than did the placebo group. The method of action for reducing platelet aggregation was the ability of policosanol to inhibit the production of inflammatory mediators arachidonic acid, thromboxane B2 and prostacyclin. By reducing platelet aggregation there was a noticeable decline in intermittent claudication. A six week study demonstrated that patients with moderately severe intermittent claudication had a considerable improvement after supplementing with policosanol. These patients reported less lower leg pain, and were able to increase their walking distance. It was noted that Policosanol did not affect the coagulation time when administered at single or repeated doses. That is to say, policosanol did not change the bleeding time similar to that of the blood thinning drug warfarin. Also, the addition of policosanol to warfarin therapy did not add to the bleeding time induced by warfarin alone. In addition to the results with heart disease patients, animal studies revealed that Policosanol protected against cerebral ischemia, suggesting a possible therapeutic effect in cerebral vascular disorders. In the animals treated with policosanol, swelling and necrosis of neurons were significantly reduced in all areas of the brain.
Female hormones, estrogen and progesterone, appear to provide a protective effect against cardiovascular disease. As women go through menopause, when hormone levels drop, there is often an elevation of cholesterol and increased risk of cardiovascular disease. A large randomized, double-blind, placebo-controlled study, with 224 postmenopausal women having elevated cholesterol was conducted to investigate the efficacy of policosanol. After eighteen weeks, the group receiving policosanol experienced a 17% reduction in total cholesterol, a 25% reduction in LDL cholesterol, and a significant 29% rise in HDL cholesterol. Four serious cardiac events occurred in the placebo group compared to none in the policosanol group.
Type II or non-insulin-dependent diabetes mellitus (NIDDM) predisposes patients to elevated cholesterol and cardiovascular disease (2, 41). Fifty-three diabetic patients with hypercholesterolemia were enrolled in a randomized, double-blind study of policosanol. After 12 weeks, total cholesterol was lowered 14%, LDL cholesterol by 20% and HDL cholesterol increased by 7.5% in the group receiving policosanol (27). Several other studies had similar positive results with type II diabetic patients (41, 42). It was noted that blood sugar levels were not affected by policosanol supplementation.
Policosanol has been found in several sources, but all of the studies, to date, have been done using material from sugar cane. Most studies have shown a positive effect at doses ranging from 5mg to 20mg daily. When evaluating policosanol for toxicity, animals were given as much as 500mg per Kg of body weight. This is over 600 times the recommended therapeutic dose. Even at these extremely high doses, there were no reports of toxicity or carcinogenicity. In human studies, patients receiving 20mg - 40mg of policosanol daily for two years had good tolerability and did not experience any adverse affects.Abstracts
Aleman CL, Mas R, Hernandez C, Rodeiro I, Cerejido E, Noa M, et al. A 12-month study of policosanol oral toxicity in Sprague Dawley rats. Toxicol Lett 1994;70(1):77-87.
Aleman CL, Mas Ferreiro R, Noa Puig M, Rodeiro Guerra I, Hernandez Ortega C, Capote A. Carcinogenicity of policosanol in Sprague Dawley rats: a 24 month study. Teratog Carcinog Mutagen 1994;14(5):239-49.
Aleman CL, Puig MN, Elias EC, Ortega CH, Guerra IR, Ferreiro RM, et al. Carcinogenicity of policosanol in mice: an 18-month study. Food Chem Toxicol 1995;33(7):573-8.
Arruzazabala ML, Molina V, Carbajal D, Valdes S, Mas R. Effect of policosanol on cerebral ischemia in Mongolian gerbils: role of prostacyclin and thromboxane A2. Prostaglandins Leukot Essent Fatty Acids 1993;49(3):695-7.
Arruzazabala ML, Mas R, Molina V, Carbajal D, Mendoza S, Fernandez L, et al. Effect of policosanol on platelet aggregation in type II hypercholesterolemic patients. Int J Tissue React 1998;20(4):119-24.
Canetti M, Moreira M, Mas R, Illnait J, Fernandez L, Fernandez J, et al. A two-year study on the efficacy and tolerability of policosanol in patients with type II hyperlipoproteinaemia. Int J Clin Pharmacol Res 1995;15(4):159-65.
Carbajal D, Arruzazabala ML, Mas R, Molina V, Valdes S. Effect of policosanol on experimental thrombosis models. Prostaglandins Leukot Essent Fatty Acids 1994;50(5):249-51.
Carbajal D, Arruzazabala ML, Valdes S, Mas R. Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers. Prostaglandins Leukot Essent Fatty Acids 1998;58(1):61-4.
Carbajal D, Arruzazabala ML, Valdes S, Mas R. Interaction policosanol-warfarin on bleeding time and thrombosis in rats. Pharmacol Res 1998;38(2):89-91.
Castano G, Mas R, Roca J, Fernandez L, Illnait J, Fernandez JC, et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology 1999;50(2):123-30.
Castano G, Mas Ferreiro R, Fernandez L, Gamez R, Illnait J, Fernandez C. A long-term study of policosanol in the treatment of intermittent claudication. Angiology 2001;52(2):115-25.
Castano G, Mas R, Fernandez JC, Illnait J, Fernandez L, Alvarez E. Effects of policosanol in older patients with type II hypercholesterolemia and high coronary risk. J Gerontol A Biol Sci Med Sci 2001;56(3):M186-92.
Castano G, Mas R, Fernandez L, Fernandez JC, Illnait J, Lopez LE, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol 2000;14(3):187-95.
Torres O, Agramonte AJ, Illnait J, Mas Ferreiro R, Fernandez L, Fernandez JC. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care 1995;18(3):393-7.
Castano G, Mas R, Fernandez L, Illnait J, Gamez R, Alvarez E. Effects of policosanol 20 versus 40 mg/day in the treatment of patients with type II hypercholesterolemia: a 6-month double-blind study. Int J Clin Pharmacol Res 2001;21(1):43-57.
Castano G, Mas R, Arruzazabala ML, Noa M, Illnait J, Fernandez JC, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res 1999;19(4):105-16.
Crespo N, Illnait J, Mas R, Fernandez L, Fernandez J, Castano G. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. Int J Clin Pharmacol Res 1999;19(4):117-27.
Gouni-Berthold I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J 2002;143(2):356-65.
Mas R, Noa M, Hernandez C, Rodeiro I, Gamez R, et al. Toxicity of policosanol in beagle dogs: one-year study. Toxicol Lett 1994;73(2):81-90.
Mas R, Castano G, Illnait J, Fernandez L, Fernandez J, Aleman C, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther 1999;65(4):439-47.
Menendez R, Fernandez SI, Del Rio A, Gonzalez RM, Fraga V, Amor AM, et al. Policosanol inhibits cholesterol biosynthesis and enhances low density lipoprotein processing in cultured human fibroblasts. Biol Res 1994;27(3-4):199-203.
Menendez R, Amor AM, Gonzalez RM, Fraga V, Mas R. Effect of policosanol on the hepatic cholesterol biosynthesis of normocholesterolemic rats. Biol Res 1996;29(2):253-7.
Menendez R, Amor AM, Rodeiro I, Gonzalez RM, Gonzalez PC, Alfonso JL, et al. Policosanol modulates HMG-CoA reductase activity in cultured fibroblasts. Arch Med Res 2001;32(1):8-12.
Menendez R, Mas R, Amor AM, Ledon N, Perez J, Gonzalez RM, et al. Inhibition of rat lipoprotein lipid peroxidation by the oral administration of D003, a mixture of very long-chain saturated fatty acids. Can J Physiol Pharmacol 2002;80(1):13-21.
Menendez R, Mas R, Amor AM, Gonzalez RM, Fernandez JC, Rodeiro I, et al. Effects of policosanol treatment on the susceptibility of low density lipoprotein (LDL) isolated from healthy volunteers to oxiative modification in vitro. Br J Clin Pharmacol 2000;50(3):255-62.
Mirkin A, Mas R, Martinto M, Boccanera R, Robertis A, Poudes R, et al. Efficacy and tolerability of policosanol in hypercholesterolemic postmenopausal women. Int J Clin Pharmacol Res 2001;21(1):31-41.
Molina V, Arruzazabala ML, Carbajal D, Valdes S, Noa M, Mas R, et al. Effect of policosanol on cerebral ischemia in Mongolian gerbils. Braz J Med Biol Res 1999;32(10):1269-76.
Noa M, de la Rosa MC, Mas R. Effect of policosanol on foam-cell formation in carrageenan-induced granulomas in rats. J Pharm Pharmacol 1996;48(3):306-9.
Noa M, Mas R, Mesa R. A comparative study of policosanol vs lovastatin on intimal thickening in rabbit cuffed carotid artery. Pharmacol Res 2001;43(1):31-7.
Noa M, Mas R, Mesa R. Effect of policosanol on circulating endothelial cells in experimental models in Sprague-Dawley rats and in rabbits. J Pharm Pharmacol 1997;49(10):999-1002.
Pons P, Rodriguez M, Robaina C, Illnait J, Mas R, Fernandez L, et al. Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharmacol Res 1994;14(1):27-33.
Prat H, Roman O, Pino E. [Comparative effects of policosanol and two HMG-CoA reductase inhibitors on type II hypercholesterolemia]. Rev Med Chil 1999;127(3):286-94.
Taber's Cyclopedic Medical Dictionary. 18th ed. Philadelphia: F A Davis Co; 1997.
Valdes S, Arruzazabala ML, Fernandez L, Mas R, Carbajal D, Aleman C, et al. Effect of policosanol on platelet aggregation in healthy volunteers. Int J Clin Pharmacol Res 1996;16(2-3):67-72.
Nutritional Sciences Inc. wishes to gratefully acknowledge Rx Vitamins and Craig Kiscaris for providing research and writing on Policosanal. This company remains on the forefront of responsible nutritional research and formulating.
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