Policosanol: benefits, dosage, contraindications

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Policosanol is a natural mixture of long-chain alcohols that is isolated from plant waxes such as sugarcane, beeswax, rice oil or wheat germ oil. The long-chain alcohols of policosanol are a mixture of alcohols with 24 to 34 carbon atoms, mainly comprising octacosanol (28-C). The main component, octacosanol, has variable absorption in the small intestine and is primarily metabolized by the liver and excreted in the feces.nnPolicosanol is most often used in the management of hyperlipidemia and has been marketed as a lipid-lowering agent in more than 40 countries worldwide.nnThe early results published before 2006 and conducted in Cuba with the primary manufacturing laboratory supported its use and indicated significant lipid-lowering activity. However, studies carried out by other research groups outside of Cuba, mainly from 2006 onward, were unable to reproduce the results obtained in the initial studies, casting doubt on the product's lipid-lowering activity.nnIt is now certain that policosanol does not have significant lipid-lowering activity, the most recent clinical trials have failed to confirm earlier positive results.

Family or group: 

Phytosubstances

Active ingredients:

Octacosanol


Indications

Scoring methodology

EFSA approval.

Several randomized, double-blind, controlled clinical trials (> 2), including a significant number of patients (>100), with consistently positive conclusions for the indication.
Several randomized, double-blind, controlled clinical trials (> 2), including a significant number of patients (>100), with positive conclusions for the indication.
One or more randomized studies, or several cohorts or epidemiological studies, with positive conclusions for the indication.
Clinical studies exist but are uncontrolled, with conclusions that may be positive or conflicting.
No clinical studies to date that can demonstrate the indication.


Intermittent claudication
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Policosanol, taken orally for up to two years, has shown a significant improvement in walking distance in patients with intermittent claudication, outperforming placebo, lovastatin, and aspirin, and equaling ticlopidine (an antiplatelet drug). Studies have found that 10 mg/day of policosanol for 6 months increases both initial and absolute walking distance. Improvements have been observed with 20 mg/day over 6 to 12 months. Policosanol has been shown to be as effective as ticlopidine in improving walking, and more effective than aspirin in a 10-week study.

Posologie

posologieOral administration

posologie10 - 20 mg

formulationStandardized extract


Hypercholesterolemia
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Studies conducted by researchers in Cuba suggest that oral policosanol at 10 to 20 mg per day reduces total cholesterol by 9 to 29% and low-density lipoprotein (LDL) cholesterol by 11 to 42%, and increases high-density lipoprotein (HDL) cholesterol by 7 to 34% in patients with hypercholesterolemia or dyslipidemia, with or without type 2 diabetes. A small number of studies conducted outside Cuba have also found beneficial effects, notably in Argentina, Mexico and China. However, most research conducted outside Cuba is contradictory. Research by German, Canadian, and Italian investigators found that daily intake of 10 to 80 mg of policosanol derived from Cuban sugarcane does not significantly reduce total cholesterol or LDL. Researchers in South Africa found that taking a product containing policosanol derived from U.S.-manufactured sugarcane at 20 mg per day for 12 weeks did not significantly reduce total cholesterol or LDL. U.S. researchers also found that taking policosanol derived from U.S.-manufactured sugarcane did not reduce total cholesterol or LDL cholesterol compared with placebo. Researchers in the Netherlands found that wheat germ-derived policosanol at 20 mg per day did not significantly reduce cholesterol after 4 weeks of treatment. Several theories may explain this discrepancy, such as differences in purity and composition among various policosanol products, insufficient trial duration, differences among subjects in the trials, and, of course, researcher bias. Further high-quality, independent research is needed to clarify the potential benefits of policosanol.

Posologie

posologieOral

posologie10 - 80 mg

formulationstandardized extract

Efficacy and tolerability of policosanol in hypercholesterolemic postmenopausal women
Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial
Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors
Effects of policosanol in older patients with type II hypercholesterolemia and high coronary risk
Sugar cane policosanol failed to lower plasma cholesterol in primitive, diet-resistant hypercholesterolemia: a double-blind, controlled study
Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia
Lack of cholesterol-lowering efficacy of Cuban sugar cane policosanols in hypercholesterolemic persons
Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial
Effects of policosanol on older patients with hypertension and type II hypercholesterolemia
Policosanol for managing human immunodeficiency virus-related dyslipidemia in a medically underserved population: a randomized, controlled clinical trial
Effects of policosanol on postmenopausal women with type II hypercholesterolemia
Wheat germ policosanol failed to lower plasma cholesterol in subjects with normal to mildly elevated cholesterol concentrations
Low dose chromium-polynicotinate or policosanol is effective in hypercholesterolemic children only in combination with glucomannan
Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and non-insulin-dependent diabetes mellitus
A comparative study of policosanol versus acipimox in patients with type II hypercholesterolemia
Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial
Effects of a policosanol supplement on serum lipid concentrations in hypercholesterolemic and heterozygous familial hypercholesterolemic subjects
Modified-policosanol does not reduce plasma lipoproteins in hyperlipidemic patients when used alone or in combination with statin therapy
Effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia associated with type 2 diabetes mellitus
A comparison of the effects of D-003 and policosanol (5 and 10 mg/day) in patients with type II hypercholesterolemia: a randomized, double-blind study
Antiplatelet effects of policosanol (20 and 40 mg/day) in healthy volunteers and dyslipidemic patients
Concomitant use of policosanol and beta-blockers in older patients

Properties


Antiplatelet agents/Anticoagulant

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Policosanol decreases platelet aggregation induced by arachidonic acid, adenosine diphosphate, and collagen. A clinical study showed that a dose of 20 mg/day of policosanol produces the same inhibitory effects on platelet aggregation as 100 mg of aspirin per day. A higher dose of 40 mg of policosanol does not appear to produce additional antiplatelet effects according to another double-blind study. Thromboxane production, but not prostacyclin, induced by collagen is also inhibited by policosanol in clinical studies. Policosanol does not appear to have a significant effect on clotting time.


Cholesterol-lowering

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Policosanol may reduce cholesterol levels by inhibiting hepatic cholesterol synthesis and by increasing the degradation of cholesterol from low-density lipoproteins (LDL). In animal models, policosanol also appears to enhance the antioxidant, anti-glycation, and anti-atherosclerotic effects of high-density lipoprotein (HDL) cholesterol. Early human studies using Cuban sugarcane policosanol showed a significant reduction in total cholesterol and low-density lipoprotein (LDL) cholesterol; however, these results have been called into question due to the plethora of negative clinical and experimental studies published since 2006, which have failed to detect a lipid-lowering activity for Cuban sugarcane policosanol and other policosanol preparations.

Usages associés

Hypercholesterolemia

Vascular effect

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Clinical research conducted in elderly patients with dyslipidemia shows that policosanol reduces levels of circulating endothelial cells, which are a measure of vascular endothelial cell injury that gives rise to atherosclerotic lesions. It also lowers homocysteine levels, thereby reducing vascular inflammation and coronary damage, and decreases C-reactive protein levels, indicating a reduction in chronic cardiovascular inflammation.

Usages associés

Intermittent claudication


Safe dosage

Adult: 5 mg - 80 mg

Doses used in clinical trials range from 5 to 80 mg/day.


Interactions

Médicaments

Aspirin: moderate interaction

An increase in antiplatelet effects may occur - patients taking aspirin and policosanol at the same time should be monitored for increased bleeding or bruising.

Warfarin: minor interaction

Some clinical research shows that taking policosanol at 10 to 50 mg per day for 7 to 15 days can inhibit platelet aggregation in healthy subjects. A clinical trial (Carbajal et al. 1998) showed that taking 10 mg of policosanol twice daily for two weeks before taking warfarin does not affect the pharmacokinetics of warfarin or the response to warfarin. Caution with doses > 10 mg/day.

Antiplatelet agents/Anticoagulants: moderate interaction

Some clinical research shows that taking policosanol at 10 to 50 mg per day for 7 to 15 days can inhibit platelet aggregation in healthy subjects. In theory, taking policosanol with other antiplatelet drugs or anticoagulants could increase the risk of bruising and bleeding.

Selective beta-blockers: moderate interaction

Clinical research shows that policosanol, at 5 mg per day, may have additive blood pressure–lowering effects in hypertensive patients taking beta-blockers. In addition, animal studies show that policosanol may increase the blood pressure–lowering effects of propranolol. In theory, concomitant use of policosanol and beta-blockers could have additive effects on lowering blood pressure.


Precautions

Surgical intervention: avoid

Policosanol has antiplatelet effects and may lower blood glucose. Policosanol may cause excessive bleeding or increase the risk of hypoglycemia if used perioperatively. It is recommended to stop policosanol at least 2 weeks before a surgical procedure.

Bleeding disorder: avoid

Policosanol has antiplatelet effects. Policosanol may cause excessive bleeding if used by patients with bleeding disorders.

Pregnancy: avoid

No evidence of teratogenicity or any other embryotoxicity in animals.

Breastfeeding: avoid

Avoid due to lack of information.