Policosanol
Policosanol , polycosanol
 
Clinical Overview
Uses
Cholesterol-lowering effects earlier attributed to policosanol have not been validated by recent trials. Policosanol has been studied in platelet aggregation and intermittent claudication, but data are insufficient to support this use.

Dosing
Policosanol has been studied at doses from 10 to 80 mg daily in adults.

Contraindications
Contraindications have not been identified.

Pregnancy/Lactation
Information regarding safety and efficacy during pregnancy and lactation is lacking.

Interactions
None well documented.

Adverse Reactions
Animal and human studies have demonstrated few or no adverse reactions from policosanol.

Toxicology
Limited animal and human studies have found policosanol to be safe.

 
Source
Policosanol is a mixture of high molecular weight, primary aliphatic alcohols (waxy substances), of which octacosanol (1-octacosanol) is the main component (approximately 60%). This monograph reviews policosanol as the mixture. For information regarding the octacosanol component, refer to the individual monograph. Policosanol is isolated from sugar cane wax or beeswax, but these sources may have different proportions of policosanol components. Octacosanol and related substances also are found in wheat germ oil, vegetable oils, alfalfa, and animal products. 1,  , 2,  , 3
 
History
Policosanol has been used most often for cholesterol-lowering effects.
 
Chemistry
Reports to determine constituents in policosanol from raw materials have been published. Eight aliphatic fatty alcohols in one study include 1-tetracosanol, 1-hexacosanol, 1-heptacosanol, 1-octacosanol, 1-nonacosanol, 1-triacontanol, 1-dotriacontanol, and 1-tetratriacontanol. 4,  , 5,  Three compounds isolated from Chinese beeswax were identified as dotriacontanol, triacontanol, and octacosanol in another report. 2
 
Uses and Pharmacology
Cholesterol reduction   Despite the proliferation of studies primarily conducted by Cuban researchers in the late 1990s and early 2000 proclaiming the efficacy of policosanol in lowering cholesterol, more recent studies have failed to validate early expectations. 6,  , 7,  , 8
Trials published in 2006 in the United States, Germany, Netherlands, Canada, and South Africa found no effect on blood lipid profiles at dosages of 10 to 80 mg daily over 4 to 12 weeks. Additionally, no synergy with atorvastatin was demonstrated in one of these trials. 7,  , 9,  , 10,  , 11,  , 12,  , 13
Other uses   Seven trials, all published by the same authors, suggest a role for policosanol in intermittent claudication and platelet aggregation inhibition. Independent validation of these trials is needed. 14,  , 15,  , 16,  , 17,  , 18,  , 19,  , 20
 
Administration & Dosage
Policosanol has been studied at doses of 10 to 80 mg daily in adults (from trials published in 2006).
 
Pregnancy/Lactation
Information regarding safety and efficacy during pregnancy and lactation is lacking.
 
Interactions
Animal studies suggest policosanol may increase the hypotensive effects of beta-blockers 21,  and nitroprusside-induced hypotensive effects. 22
 
Adverse Reactions
Policosanol appears to be generally well tolerated in human trials. Adverse reactions recorded in these trials include rash, fatigue, headache, weight loss, excess urination, and insomnia. 9,  , 10,  , 12,  , 14,  , 15,  , 16,  , 17,  , 18,  , 19,  , 20
 
Toxicology
In rats, administration of the drug did not adversely effect reproductive performance and fetal development. 23,  It also was nonteratogenic in rats and rabbits. 24,  No evidence of carcinogenicity was observed in mice 25,  or rats. 26
 
References
 

1. Gouni-Berthold I , Berthold HK . Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent . Am Heart J . 2002;143(2):356-365.  PubMed

 

2. Liu F , Sun D . Active constituents lowering blood-lipid in beeswax [in Chinese] . Zhongguo Zhong Yao Za Zhi . 1996;21(9):553-554, 576.  PubMed

 

3. Saint-John M , McNaughton L . Octacosanol ingestion and its effects on metabolic responses to submaximal cycle ergometry, reaction time and chest and grip strength . Int Clin Nutr Rev . 1986;6:81-87.

 

4. Gonzalez VL , Magraner J , Otero T , Garcia E . Validation and interlaboratory study of a new GC analytical method for the determination of policosanol in raw material [in Spanish] . Rev CENIC Cienc Quim . 1999;30:148-152.

 

5. Gonzalez CV , Magraner HJ . Validation of a gas chromatographic method for determining fatty alcohols that compose policosanol in five-milligram film-coated tablets . J AOAC Int . 1999;82(4):834-839.

 

6. Policosanol: a sweet nothing for high cholesterol . Harv Heart Lett . 2006;17(1):7.

 

7. Lin Y , Rudrum M , van der Wielen RP , et al. Wheat germ policosanol failed to lower plasma cholesterol in subjects with normal to mildly elevated cholesterol concentrations . Metabolism . 2004;53(10):1309-1314.  PubMed

 

8. Chen JT , Wesley R , Shamburek RD , Pucino F , Csako G . Meta-analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol . Pharmacotherapy . 2005;25(2):171-183.  PubMed

 

9. Cubeddu LX , Cubeddu RJ , Heimowitz T , Restrepo B , Lamas GA , Wienberg GB . Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial . Am Heart J . 2006;152(5):982. e1.5.  PubMed

 

10. Dulin MF , Hatcher LF , Sasser HC , Barringer TA . Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial . Am J Clin Nutr . 2006;84(6):1543-1548.  PubMed

 

11. Kassis AN , Jones PJ . Lack of cholesterol-lowering efficacy of Cuban sugar cane policosanols in hypercholesterolemic persons . Am J Clin Nutr . 2006;84(5):1003-1008.  PubMed

 

12. Greyling A , De Witt C , Oosthuizen W , Jerling JC . Effects of a policosanol supplement on serum lipid concentrations in hypercholesterolaemic and heterozygous familial hypercholesterolaemic subjects . Br J Nutr . 2006;95(5):968-975.  PubMed

 

13. Berthold HK , Unverdorben S , Degenhardt R , Bulitta M , Gounti-Berthold I . Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial . JAMA . 2006;295(19):2262-2269.  PubMed

 

14. Arruzazabala ML , Valdés S , Más R , Carbajal D , Fernández L . Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers . Pharmacol Res . 1997;36(4):293-297.  PubMed

 

15. Arruzazabala ML , Valdés S , Más R , Fernández L, Carbajal D . Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers . Pharmacol Res . 1996;34(5-6):181-185.  PubMed

 

16. Arruzazabala ML , Más R , Molina V , et al. Effect of policosanol on platelet aggregation in type II hypercholesterolemic patients . Int J Tissue React . 1998;20(4):119-124.  PubMed

 

17. Carbajal D , Arruzazabala ML , Valdés S , Más 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):61-64.

 

18. Valdés S , Arruzazabala ML , Fernández L , et al. Effect of policosanol on platelet aggregation in healthy volunteers . Int J Pharmacol Res . 1996;16(2-3):67-72.  PubMed

 

19. Castaño G , Más R , Roca J , et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication . Angiology . 1999;50(2):123-130.  PubMed

 

20. Castaño G , Más Ferreiro R , Fernández L , Gámez R , Illnait J , Fernández C . A long-term study of policosanol in the treatment of intermittent claudication . Angiology . 2001;52(2):115-125.  PubMed

 

21. Molina Cuevas V , Arruzazabala ML , Carbajal Quintana D , Más Ferrerio R , Valdés García S . Effect of policosanol on arterial blood pressure in rats. Study of the pharmacological interaction with nifedipine and propranolol . Arch Med Res . 1998;29(1):21-24.  PubMed

 

22. Arruzazabala ML , Carbajal D , Más R , Valdés S , Molina V . Pharmacological interaction between policosanol and nitroprusside in rats . J Med Food . 2001;4(2):67-70.  PubMed

 

23. Rodríguez MD , García H . Evaluation of peri- and post-natal toxicity of Policosanol in rats . Teratog Carcinog Mutagen . 1998;18(1):1-7.

 

24. Rodríguez MD , García H . Teratogenic and reproductive studies of policosanol in the rat and rabbit . Teratog Carcinog Mutagen . 1994;14(3):107-113.  PubMed

 

25. Alemán CL , Puig MN , Elías EC , et al. Carcinogenicity of policosanol in mice: an 18-month study . Food Chem Toxicol . 1995;33(7):573-578.  PubMed

 

26. Alemán CL , Más Ferreiro R , Noa Puig M , Rodeiro Guerra I , Hernández Ortega C , Capote A . Carcinogenicity of policosanol in Sprague Dawley rats: a 24-month study . Teratog Carcinog Mutagen . 1994;14(5):239-249.  PubMed