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 bran oil, or wheat germ. The long-chain alcohols in policosanol are a mixture of alcohols with 24 to 34 carbon atoms, primarily consisting of octacosanol (28-C). The main component, octacosanol, has variable absorption in the small intestine and is mainly metabolized by the liver and excreted in the feces. Policosanol is most commonly used in the management of hyperlipidemia and has been marketed as a hypolipidemic agent in more than 40 countries worldwide. Early results published before 2006 and conducted in Cuba with the main manufacturing laboratory supported its use and indicated significant hypolipidemic activity. However, studies conducted by other research groups outside of Cuba, primarily starting in 2006, have not been able to reproduce the results obtained in the initial studies, casting doubt on the hypolipidemic activity of the product. It is now certain that policosanol does not have significant hypolipidemic activity, as the most recent clinical trials have failed to confirm the previous positive results.

Other name(s) 

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Family or group: 

Phytosubstances

Active ingredients:

Octacosanol


Indications

Rating methodology

EFSA approval.

Several clinical trials (> 2) randomized controlled with double blind, including a significant number of patients (>100) with consistently positive outcomes for the indication.
Several clinical trials (> 2) randomized controlled with double blind, and including a significant number of patients (>100) with positive outcomes for the indication.
One or more randomized studies or multiple cohorts or epidemiological studies with positive outcomes for the indication.
Clinical studies exist but are uncontrolled, with conclusions that may be positive or contradictory.
Lack of 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, surpassing placebo, lovastatin, and aspirin, and equaling ticlopidine (an antiplatelet drug). Studies have revealed 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 proven to be as effective as ticlopidine for improving walking, and more effective than aspirin in a 10-week study.

Posologie

posologieOral route

posologie10 - 20 mg

formulationstandardized extract


Hypercholesterolemia
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Studies conducted by researchers in Cuba suggest that taking policosanol orally at a dose of 10 to 20 mg per day decreases total cholesterol by 9 to 29% and LDL cholesterol by 11 to 42%, and increases 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 of Cuba have also found beneficial effects, notably in Argentina, Mexico, and China. However, the majority of research conducted outside of Cuba is contradictory. Research by German, Canadian, and Italian researchers has revealed that daily intake of 10 to 80 mg of policosanol derived from Cuban sugarcane does not significantly reduce total or LDL cholesterol. South African researchers found that taking a product containing policosanol derived from sugarcane manufactured in the United States at 20 mg per day for 12 weeks does not significantly reduce total or LDL cholesterol. American researchers also found that taking policosanol derived from U.S.-made sugarcane does not reduce total or LDL cholesterol compared to placebo. Researchers from the Netherlands found that policosanol derived from wheat germ, at 20 mg per day, did not significantly reduce cholesterol after 4 weeks of treatment. Several theories could explain this divergence, such as differences in purity and composition of different policosanol products, insufficient duration of trials, differences between subjects in trials, and of course, researcher bias. High-quality, independent, additional research is needed to clarify the potential benefits of policosanol.

Posologie

posologieOral route

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 noninsulin 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-blinded 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


Anti-aggregate Platelets/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 seems not 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 seem to have a significant effect on coagulation time.


Hypocholesterolemic

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Policosanol may reduce cholesterol levels by inhibiting hepatic cholesterol synthesis and increasing the breakdown of low-density lipoproteins (LDL) cholesterol. In animal models, policosanol also seems 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 LDL cholesterol; however, these results are questioned due to a multitude of negative clinical and experimental studies published since 2006, which have not been able to detect hypolipidemic activity for Cuban sugarcane Policosanol and other policosanol-based preparations.

Usages associés

Hypercholesterolemia

Vascular Effect

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

Usages associés

Intermittent Claudication


Safety 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 develop - patients taking aspirin and policosanol together should be monitored for increased bleeding or bruising.

Warfarin: minor interaction

Some clinical research shows that taking policosanol at a dose of 10 to 50 mg per day for 7 to 15 days may inhibit platelet aggregation in healthy patients. 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/Anticoagulant: moderate interaction

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

Selective beta-blocker: moderate interaction

Clinical research shows that policosanol, at a dose of 5 mg per day, may have additive hypotensive effects in hypertensive patients taking beta-blockers. Additionally, animal research shows that policosanol may enhance the hypotensive effects of propranolol. In theory, the concurrent use of policosanol and beta-blockers could have additive effects on lowering blood pressure.


Precautions

Surgical intervention: avoid

Policosanol has antiplatelet effects and may reduce 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 surgery.

Blood clotting disorder: avoid

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

Pregnant women: avoid

No evidence of teratogenicity or any other embryotoxicity in animals.

Breastfeeding women: avoid

Avoid due to lack of information.