Policosanol

Category

Herbs & Supplements

Synonyms

Hexacontanol, isopolicosanol, Octa-6, Octa-60, octacosanoic acid, octacosanol, policosanol, Ricewax, SCP, SFP, SFP winteriser cake, sugar cane policosanol, sunflower seed policosanols, triacontanol, wheat germ policosanol.

Background

Policosanol is a cholesterol-lowering natural mixture of primary alcohols, isolated and purified from sugar cane wax. Policosanol is safe and well tolerated, even in populations with high use of concomitant medications.

Lipid profile improvements with the use of policosanol are seen in healthy volunteers, patients with type II hypercholesterolemia (high cholesterol), type 2 diabetics with hypercholesterolemia, postmenopausal women with hypercholesterolemia, and patients with combined hypercholesterolemia and abnormal liver function tests. However, there is controversy in this are based on recent negative evidence.

Policosanol has performed equal to or better than simvastatin, pravastatin, lovastatin, probucol, or acipimox with fewer side effects in patients with type II hypercholesterolemia.

Policosanol was approved for use in Cuba in 1991. Currently it is used in more than 25 countries throughout the world, mainly in South America and in the Caribbean region.

Evidence

DISCLAIMER: These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Platelet aggregation inhibition: Various studies have investigated the effect of policosanol on platelet aggregation. In general, studies suggest policosanol inhibits platelet aggregation induced by collagen and arachidonic acid.
Grade: A

Coronary Heart Disease (CHD): The effects of policosanol supplementation on exercise-ECG testing responses have been studied in individuals with coronary heart disease (CHD). Beneficial changes were noted in functional capacity, rest and exercise angina (chest pain), cardiac events and maximum oxygen uptake. Although this represents early compelling evidence, further research is necessary before a clear conclusion can be reached.
Grade: B

Intermittent claudication (IC): There is limited study of the effects of policosanol supplementation on walking distance in individuals with intermittent claudication. Additional human trials are necessary before a strong recommendation can be made.
Grade: B

High cholesterol: Policosanol has been used and recommended to treat high cholesterol (hypercholesterolemia). Many studies have tested the effects of policosanol on cholesterol levels, and have found benefits. However, some newer research suggests that policosanol may not be as beneficial as previously thought.
Grade: C

Reactivity/brain activity: The effects of policosanol supplementation on reactivity and related brain activity have been examined. Although there is early compelling evidence, further research is necessary before a clear conclusion can be reached.
Grade: C

Tradition

WARNING: DISCLAIMER: The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.
Antiangiogenesis, antioxidant, atheroma (fatty material that builds up in the arteries and may lead to heart problems), atherosclerotic lesions (disease of arterial blood vessels), cerebral ischemia (lack of adequate blood flow to the brain), cerebrovascular disorders (disorders of the blood vessels in the brain), heart damage, high blood pressure, iatrogenic lipodystrophy (defective metabolism), liver damage, postmenopausal osteoporosis, stroke prevention, tumor (granuloma).

Dosing

Adults (18 years and older):

Typical doses of policosanol are between 5-40 milligrams daily. Policosanol appears safe in these doses for up to three years. Based on the available evidence, this dose range is considered safe and effective in patients with coronary heart disease and for patients with type II hypercholesterolemia (high cholesterol). Doses as high as 80 grams of policosanol have been taken daily for 12 weeks to treat high cholesterol. For platelet aggregation, 10-40 milligrams daily has been taken. For intermittent claudication, 10-20 milligrams has been used, and for hypertension (high blood pressure), a lower dose of 5-10 milligrams daily has been taken.

Children (younger than 18 years):

There is no proven safe or effective dose for policosanol in children.

Safety

DISCLAIMER: Many complementary techniques are practiced by healthcare professionals with formal training, in accordance with the standards of national organizations. However, this is not universally the case, and adverse effects are possible. Due to limited research, in some cases only limited safety information is available.

Allergies

Avoid in individuals with a known allergy or hypersensitivity to policosanol.

Side Effects and Warnings

Policosanol is generally regarded as safe and well tolerated. However, there are a few, minor drug-related clinical or biochemical adverse effects observed in clinical trials. Frequency of mild, moderate and serious adverse events, as well a death rate, has been shown to be lower in diabetic and non-diabetic individuals taking policosanol compared with placebo.

Policosanol may cause erythema (reddening of the skin), gum bleeding, headache, vertigo, or heartburn. Use cautiously in patients taking aspirin due to potential additive platelet inhibition and risk of bleeding. Also use caution in patients with high blood pressure or those taking agents to lower blood pressure due to a potential additive effect. Side effects of Octa-60g (a combination product including policosanol) may include skin rash, and increased glucose and alanine aminotransferase.

Pregnancy and Breastfeeding

Policosanol is not recommended in pregnant or breastfeeding women due to a lack of available scientific evidence. Although not well studied in humans, policosanol does not appear to affect reproductive performance, fetal/neonatal development, or breastfeeding. Additional study is needed in this area.

Interactions

Interactions with Drugs

In theory, policosanol may interact additively with nicotinic acid (Acipimox®) or synthetic nicotinic acid due to Acipimox®'s cholesterol-lowering activity. Caution is advised in patients taking other cholesterol-lowering agents. In theory, bile acid sequestrants/resins, ezetimibe (Zetia®), or statins (lovastatin, atorvastatin, simvastatin, pravastatin) may have an additive cholesterol-lowering effect when given with policosanol.

Policosanol may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anti-platelet drugs such as clopidogrel (Plavix®), and non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®). The addition of policosanol to warfarin therapy did not enhance the prolongation of the bleeding time induced by warfarin alone.

Policosanol may decrease arterial pressure, and thus may have additive effects with beta-blockers, or other blood pressure-lowering agents. Medication adjustments may be necessary.

Although not well studied in humans, the activity of nifedipine remained unchanged in animals treated with a high dose policosanol. There is no information regarding potential interaction with other calcium channel blockers.

Because policosanol possesses an antioxidant effect and nitric oxide can be destroyed by oxygen-derived radicals, there is a theoretical interaction between policosanol and nitroprusside and other nitrates. Consult with a qualified healthcare professional, including a pharmacist, to check for any interactions.

In theory, taking ticlopidine and policosanol together may cause an additive interaction.

Although not well studied in humans, policosanol may also interact with agents broken down by the liver, or agents taken for Alzheimer's disease, cardiovascular disorders, diabetes or neurologic disorders.

Interactions with Herbs and Dietary Supplements

In theory, there may be an additive hypotensive (blood pressure lowering) effect when policosanol is used with herbs that lower blood pressure.

In theory, additive hypocholesterolemic (cholesterol-lowering) effects may occur when policosanol is used with herbs that decrease cholesterol levels, such as plant sterols, plant stanols, polyphenols, psyllium, soy proteins, soy isoflavones, red yeast, or garlic powder.

Concurrent therapy with policosanol and omega-3 fatty acids may have an additive lowering effect on the lipid profile and platelet aggregation. Caution is advised.

Although not well studied in humans, policosanol may also interact with herbs and supplements broken down by the liver, or herbs and supplements taken for Alzheimer's disease, cardiovascular disorders, diabetes or neurologic disorders.

Attribution

This information is based on a systematic review of scientific literature, and was peer-reviewed and edited by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com): Tracee Rae Abrams, PharmD (University of Rhode Island); Ethan Basch, MD (Memorial Sloan-Kettering Cancer Center); Julie Conquer, PhD (RGB Consulting); Nicole Giese, MS (Boston University); Dana Hackman, BS (Northeastern University); Ben Kligler, MD, MPH; Tamara Milkin, PharmD (Northeastern University); Erica Seamon, PharmD (Nova Southeastern University); Shaina Tanguay-Colucci, BS (Natural Standard Research Collaboration); Catherine Ulbricht, PharmD (Massachusetts General Hospital); Wendy Weissner, BA (Natural Standard Research Collaboration); Jen Woods, BS (Natural Standard Research Collaboration).

Bibliography

DISCLAIMER: Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.

Bays H, Stein EA. Pharmacotherapy for dyslipidaemia--current therapies and future agents. Expert Opin Pharmacother 2003;4(11):1901-1938.

Berthold HK, Unverdorben S, Degenhardt R, et al. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial. JAMA 2006 May 17;295(19):2262-9.

Castaño G, Más R, Fernández L, et al. A comparison of the effects of D-003 and policosanol (5 and 10 mg/day) in patients with type II hypercholesterolemia: a randomized, double-blinded study. Drugs Exp Clin Res 2005;31 Suppl:31-44.

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

Cubeddu LX, Cubeddu RJ, Heimowitz T, et al. Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial. Am Heart J 2006 Nov;152(5):982.e1-5.

Dulin MF, Hatcher LF, Sasser HC, et al. Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial. Am J Clin Nutr 2006 Dec;84(6):1543-8.

Francini-Pesenti F, Beltramolli D, Dall'acqua S, Brocadello F. Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia. Phytother Res. 2008 Mar;22(3):318-22.

Gamez R, Maz R, Arruzazabala ML, et al. Effects of concurrent therapy with policosanol and omega-3 fatty acids on lipid profile and platelet aggregation in rabbits. Drugs R D 2005;6(1):11-19.

Greyling A, De Witt C, Oosthuizen W, et al. Effects of a policosanol supplement on serum lipid concentrations in hypercholesterolaemic and heterozygous familial hypercholesterolaemic subjects. Br J Nutr 2006 May;95(5):968-75.

Illnait J, Castaño G, Alvarez E, Fernández L, Mas R, Mendoza S, Gamez R. Effects of policosanol (10 mg/d) versus aspirin (100 mg/d) in patients with intermittent claudication: a 10-week, randomized, comparative study. Angiology. 2008 Jun-Jul;59(3):269-77.

Kassis AN, Jones PJ. Changes in cholesterol kinetics following sugar cane policosanol supplementation: a randomized control trial. Lipids Health Dis. 2008 Apr 30;7:17.

Mas R, Castano G, Fernandez J, et al. Long-term effects of policosanol on obese patients with Type II Hypercholesterolemia. Asia Pac J Clin Nutr 2004;13(Suppl):S102.

McCarty MF. An ezetimibe-policosanol combination has the potential to be an OTC agent that could dramatically lower LDL cholesterol without side effects. Med Hypotheses 2005;64(3):636-645.

Reiner Z, Tedeschi-Reiner E. Rice policosanol does not have any effects on blood coagulation factors in hypercholesterolemic patients. Coll Antropol. 2007 Dec;31(4):1061-4.

Tedeschi-Reiner E, Reiner Z, Romić Z, et al. [A randomized, double-blind, placebo-controlled study of the antilipemic efficacy and tolerability of food supplement policosanol in patients with moderate hypercholesterolemia]. Lijec Vjesn 2005 Nov-Dec;127(11-12):273-9.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.