Lipotrene by Mosaic Nutraceuticals Corp

LIKELY EFFECTIVE

• Intermittent claudication. Oral use of policosanol can increase walking distance in patients with intermittent claudication. Details: Multiple, small, randomized controlled trials show that taking policosanol 10 mg orally once to twice daily for up to 2 years moderately improves walking distance when compared with placebo, lovastatin, or aspirin, and has similar effects to ticlopidine, in patients with intermittent claudication (2931,65359,65372,65378,69114).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angioplasty. It is unclear if oral policosanol is beneficial for patients after angioplasty. Details: Preliminary clinical research has evaluated the addition of policosanol to dual antiplatelet therapy in Chinese patients with high on-treatment platelet reactivity (HPR) who underwent percutaneous coronary intervention with a drug-eluting stent for an acute coronary syndrome. The addition of policosanol 40 mg orally daily with clopidogrel 75 mg daily and aspirin 300 mg daily for 30 days does not further reduce HPR when compared with taking clopidogrel and aspirin alone (100684).
• Coronary heart disease (CHD). It is unclear if oral policosanol is beneficial for patients with CHD. Details: One small clinical study in adults with CHD shows that taking policosanol 5 mg twice daily, alone or in combination with aspirin 125 mg for 20 months, can reduce cardiac events and improve maximum oxygen uptake during a treadmill exercise electrocardiogram (ECG) when compared with pretreatment (2941). Policosanol has also been evaluated as part of combination products for CHD. Clinical research in statin-intolerant patients with CHD treated with a percutaneous intervention (PCI) shows that taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing policosanol, berberine, red yeast rice, folic acid, coenzyme Q10, and astaxanthin daily for 3 months reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, and increases high-density lipoprotein (HDL) cholesterol, to a greater extent than ezetimibe 10 mg daily. Combining this specific product with ezetimibe produces additional improvements after 1 year of treatment when compared with either agent alone (97232). Other clinical research in patients with CHD treated with PCI shows that taking the same product in combination with a low-dose statin for 3 months reduces total cholesterol and LDL cholesterol and increases HDL cholesterol when compared with low-dose statin treatment alone (97233). It is unclear if the benefits of this combination product are due to policosanol, other ingredients, or the combination.
• Familial hypercholesterolemia. It is unclear if oral policosanol is beneficial for patients with familial hypercholesterolemia. Details: Preliminary clinical research shows that taking a specific form of policosanol (Lesstanol Octa-60, Garuda International) 20 mg orally daily for 12 weeks does not significantly decrease total or low-density lipoprotein (LDL) cholesterol in patients with familial hypercholesterolemia (14404).
• Hypercholesterolemia. It is unclear if oral policosanol is beneficial for patients with hypercholesterolemia. Details: Current clinical research on the use of policosanol for hyperchloremia is conflicting. The reasons for these discrepant findings are unclear but may be explained by differences in doses, treatment durations, patient populations, and specific policosanol products studied. Clinical research in subjects with hypercholesterolemia, largely conducted by researchers in Cuba, shows that taking policosanol orally 5-20 mg daily for 8-24 weeks lowers 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% when compared with placebo or other controls (2927,2928,2929,2930,2943,2944,14298,14411,65348,65354)(65355,65356,65361,65363,65365,65369,65375,65380,65383,69104)(69105,69106,65362,65351,100178). When compared to conventional drugs, some research also shows that policosanol 10 mg daily lowers total and LDL cholesterol by a similar amount as fluvastatin 20 mg daily and simvastatin 10 mg daily (8147,12190). Atorvastatin 10 mg daily appears to be more effective than policosanol 10 mg daily for lowering total and LDL cholesterol (14411). However, the majority of research conducted outside of Cuba has been contradictory. Research in subjects with hypercholesterolemia, conducted by German, Canadian, Croatia, South African, Netherlands, U.S., and Italian researchers, shows that taking policosanol 10-80 mg daily for 4-12 weeks does not significantly decrease total or LDL cholesterol when compared with placebo (14336,15062,69111,69119,69107,69109,69110,12166,14404). These studies included policosanol derived from Cuban sugar cane, U.S. sugar cane, wheat germ, and red yeast rice and specific policosanol products (Lesstanol Octa-60, Garuda International; Cholesstor, Pharmed Group) (69107,69109,69110,12166,14404). Policosanol has also been studied in combination with other ingredients. Taking a product containing policosanol 10 mg, berberine 500 mg, and red yeast rice 200 mg daily for up to 12 months seems to reduce total cholesterol and LDL cholesterol levels in hypercholesterolemic patients when compared with placebo or ezetimibe 10 mg (34262,34283,34301). Taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing policosanol, berberine, red yeast rice, folic acid, coenzyme Q10, and astaxanthin daily for 8 weeks appears to reduce total cholesterol by 13% and LDL cholesterol by 21%, as well as increasing HDL cholesterol by 5% when compared with baseline in patients with metabolic syndrome and dyslipidemia (89438). A meta-analysis also shows that taking this combination product for up to 1 year reduces total cholesterol by 10%, LDL cholesterol by 14%, and triglycerides by 7%, and increases HDL cholesterol by 4%, when compared with baseline in patients with hypercholesterolemia (92142). It is unclear if the benefits of this combination product are due to policosanol, red yeast rice (which contains monacolin K, a chemical similar to lovastatin), other ingredients, or the combination.
• Hypertension. It is unclear if oral policosanol is beneficial for patients with hypertension. Details: Clinical research in adults with prehypertension shows that taking policosanol 20 mg orally daily for 12 weeks reduces both systolic and diastolic blood pressure by about 7%, compared to non-significant changes with placebo. A lower dose of policosanol 10 mg daily did not improve blood pressure when compared with placebo (100177).
• Metabolic syndrome. Oral policosanol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing policosanol, berberine, red yeast rice, folic acid, coenzyme Q10, and astaxanthin daily for 18 weeks improves systolic blood pressure, left ventricular mass, and flow-mediated dilation in patients with metabolic syndrome when compared with control (34289). It is unclear if these effects are due to policosanol, other ingredients, or the combination. More evidence is needed to rate policosanol for these uses.

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LIKELY SAFE ...when used orally and appropriately in medicinal amounts. Policosanol seems to be safe when used in doses of 5-80 mg daily for up to 3 years (2927,2928,2929,2930,2931,2943,2944,12166,14298,14336)(14404,14411,65383,89438,89454,89451,100178,103832).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking policosanol with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.  Details Some clinical research shows that taking policosanol 10-50 mg daily for 7-15 days can inhibit platelet aggregation in healthy patients (2936,2937,2938,103832). Although, one clinical trial shows that taking policosanol 10 mg twice daily for 2 weeks prior to warfarin dosing does not affect warfarin pharmacokinetics or warfarin response (20083). Furthermore, a study in patients undergoing percutaneous coronary intervention with a drug-eluting stent found that taking policosanol 40 mg plus clopidogrel and aspirin daily for 30 days modestly reduced the risk for minor bleeding events when compared with taking clopidogrel and aspirin alone (100684). Until more is known, use with caution.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, policosanol might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia.  Details Clinical research shows that policosanol can lower blood glucose levels (100178).

BETA-BLOCKERS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Concomitant use of policosanol with beta-blockers can cause additive blood pressure-lowering effects.  Details Clinical research shows that policosanol 5 mg daily can have additive blood pressure-lowering effects in patients with hypertension who are taking beta-blockers (65383). Also, animal research shows that policosanol can increase the blood-pressure lowering effects of propranolol (23775).

NITROPRUSSIDE (Nitropress) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of policosanol with nitroprusside might cause additive blood pressure-lowering effects.  Details Animal research shows that taking policosanol along with nitroprusside can increase the blood pressure-lowering effects of nitroprusside (65374).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking policosanol with warfarin might increase the risk of bruising and bleeding.  Details Some clinical research shows that taking policosanol 10-50 mg daily for 7-15 days can inhibit platelet aggregation in healthy patients (2936,2937,2938). However, one clinical trial shows that taking policosanol 10 mg twice daily for 2 weeks prior to warfarin dosing does not affect warfarin pharmacokinetics or warfarin response (20083).

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General ...Orally, policosanol is usually well-tolerated.
Most Common Adverse Effects:
Orally: Dysuria, headache, insomnia, polyphagia, pruritis, skin rash, somnolence, upset stomach, vertigo, weight loss.

Dermatologic ...Orally, policosanol can cause pruritus or skin rash, but these events appear to be uncommon (65369,95374,100178). In one clinical trial that included over 50 patients, one case of policosanol-associated skin rash was reported (65369). In another study, 1 out of 40 patients treated with policosanol 10 mg daily reported pruritus (95374).

Gastrointestinal ...Orally, policosanol can cause upset stomach or polyphagia (2937).

Genitourinary ...Orally, policosanol can cause dysuria (2937).

Hematologic ...A case gum bleeding has been reported in a patient taking policosanol 20 mg and aspirin 100 mg daily for 7 days (2937).

Neurologic/CNS ...Orally, policosanol may cause headache, mild vertigo, somnolence, irritability, or insomnia but these events are uncommon. In one clinical study, 1 out of 44 subjects receiving policosanol 20 mg daily 12 weeks experienced mild vertigo and 2 out of 44 experienced mild headache (14404). In another study, 2 out of 70 patients taking policosanol 10 mg daily for 8 weeks experienced headache (69119). In another study, 1 out of 40 patients taking policosanol 10 mg daily reported insomnia (95374).

Other ...Orally, policosanol has been associated with weight loss. However, evidence from a post-market surveillance study of patients taking policosanol 5-15 mg daily shows that this adverse event is uncommon (95375).

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