Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia

Berthold, Heiner K.; Unverdorben, Susanne; Degenhardt, Ralf; Bulitta, Michael; Gouni‐Berthold, Ioanna

doi:10.1001/jama.295.19.2262

Cited by 152 publications

(127 citation statements)

References 26 publications

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“…The data presented for the NEP group are consistent with recent studies showing the lack of policosanol effect in modifying total or LDLcholesterol (Greyling et al, 2006;Berthold et al, 2006;Dulin et al, 2006;Kassis and Jones, 2006;Francini-Pesenti et al, 2008a;Francini-Pesenti et al, 2008b;Kassis et al, 2007;Murphy et al, 2008), considering that the supplementation of rats with 100 mg/kg body weight of NEP, the same form of administration in previously reported investigations, did not alter lipid concentrations when compared to the control group. Nevertheless, the OAEP group exhibited significantly lower concentrations of plasmatic LDL-cholesterol, as the primary endpoint, and total cholesterol, as the secondary endpoint, in normocholesterolemic rats after 5 weeks of treatment.…”

Section: The Oleic Acid Esterification Of Policosanol Increases Its Bsupporting

confidence: 91%

“…However, recent clinical trials failed to show significant effects. In fact, no changes in lipid variables in subjects receiving policosanol were reported (Greyling et al, 2006;Berthold et al, 2006;Dulin et al, 2006;Kassis and Jones, 2006) and neither primary hypercholesterolemic subjects (Francini-Pesenti et al, 2008a) nor diet-resistant hypercholesterolemic patients (Francini-Pesenti et al, 2008b) were affected by policosanol treatment for 8 weeks.…”

Section: Introductionmentioning

confidence: 96%

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The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in rats

Haim¹,

Valenzuela²,

Brañes³

et al. 2012

Grasas y Aceites

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(DH, and AV); d Naturalis S.A., Santiago, Chile (MCB, and MF) *Corresponding author: dnhaim@miuandes.cl RESUMEN La esterificación de ácido oleico en policosanoles aumenta su biodisponibilidad y el efecto hipocolesterolémico en ratasLos Policosanoles están formados por una mezcla de alcoholes alifáticos de cadena larga y se obtienen de las ceras de la caña de azúcar. Más de cincuenta estudios indican que los policosanoles reducen el colesterol sérico, mientras que otros no logran reproducir este efecto. El objetivo de esta investigación fue evaluar la biodisponibilidad de policosanoles esterificados y no esterificados (NEP), en relación con sus efectos hipocolesterolémicos. Para ello, a ratas Sprague Dawley se les administró una dosis oral diaria de 100 mg kg -1 de NEP, 117 mg kg -1 de policosanoles esterificados con ácido butírico (BAEP), ó 164 mg kg -1 de policosanoles esterificados con ácido oleico (OAEP). La absorción de los policosanoles se evaluó en el plasma entre 0 y 3 horas después de la ingestión. Para evaluar los cambios en el colesterol total, colesterol-LDL, colesterol-HDL y triglicéridos en el plasma y en la fosforilación de la hígado 3-hidroxi-3-metilglutaril coenzima A reductasa (HMG-CoA red), la ingesta de las ratas fue suplementada con policosanoles no esterificados o esterificados durante 5 semanas. Los resultados indicaron que la absorción de los policosanoles fue significativamente mayor en las ratas tratadas con los OAEP que en las sometidas a los NEP o las que se les administró BAEP. Los OAEP redujeron significativamente el colesterol plasmático total y el colesterol-LDL de las ratas, además de aumentar 5.6 veces (P < 0,05) sobre los valores control, en el contenido hepático de la HMG-CoA fosforilada red. En conclusión, la esterificación de policosanoles con ácido oleico aumenta la biodisponibilidad de los policosanoles, y mejora significativamente el perfil de lípidos séricos en ratas normocolesterolémicos en asociación con la inactivación de la colesterogénesis control HMG-CoA red. PALABRAS-CLAVE: Absorción de Policosanoles -Biodisponibilidad -Efecto reductor de colesterol -Octacosanol -Policosanol -Triacontanol -Ratas. SUMMARY The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in ratsPolicosanol comprises a mixture of long-chain aliphatic alcohols from sugarcane wax. More than 50 studies indicate that policosanol decreases serum cholesterol, while others failed to reproduce this effect. The objective of this investigation was to assess the bioavailability of esterified policosanol and non-esterified policosanol (NEP), in relation to their hypocholesterolemic effects. Sprague Dawley rats were given a daily oral dose of 100 mg/kg of NEP, 117 mg kg -1 of butyric acid esterified policosanol (BAEP), or 164 mg kg -1 of oleic acid esterified policosanol (OAEP). Policosanol absorption was evaluated in plasma between 0 and 3 hours after ingestion. To assess changes in total cholesterol, LDL-cholesterol, HDLcholesterol and triacylglycerols in ...

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Section: The Oleic Acid Esterification Of Policosanol Increases Its Bsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 96%

The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in rats

Haim¹,

Valenzuela²,

Brañes³

et al. 2012

Grasas y Aceites

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“…When given as a single oral dose, AS (160 mg) maximally inhibits platelet function within 30 minutes. Repeat doses have a cumulative effect and platelet TXA 2 formation and platelet aggregation are maximally inhibited (95%) after 4-5 days [26,27]. Then, the lack of significant reduction of platelet aggregation in the pla + AS group here found is reasonable, since all patients had at least one week on AS therapy at randomization.…”

Section: Discussionmentioning

confidence: 50%

“…We also found that poli + AS reduced low-density lipoprotein-cholesterol (LDL-C) by 16.7% (week 12) and 25.5% (week 24) as compared to pla + AS, and that also had benefits on total cholesterol and HDL-C. Although some trials have failed to find lipid lowering effects of other policosanol tablets [27][28][29], the cholesterollowering effects here seen are consistent with previous experimental [30][31][32][33][34] and clinical [35][36][37][38] data of policosanol. Since statins may improve outcomes in acute ischemic stroke [39,40], these effects of poli + AS treatment could have contributed to the neurological recovery of study patients.…”

Section: Discussionmentioning

confidence: 76%

Effects of policosanol on the recovery of ischemic stroke: a randomized controlled study

Sánchez¹

2012

iosrphr

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Background. Antiplatelet therapy lowers the risk of recurrent stroke. Policosanol, a mixture of 8 high molecular weight sugar cane wax alcohols, has shown to reduce platelet aggregation. Objectives. To investigate whether the therapy with policosanol plus aspirin (AS) could improve the neurological outcome as compared to placebo + AS in patients with a recent ischemic stroke. Methods. Ninety-two (92) patients with a modified Rankin Scale score (mRSs) ≥2 -≤4 after suffering an ischemic stroke within 30 days before enrollment were randomized to placebo or policosanol (20 mg/day) + AS (125 mg/day) (pla + AS or poli + AS) for 24 weeks. The primary efficacy variable was to obtain a better stroke outcome (mRSs ≤1) as compared to pla +AS. Reduction of platelet aggregation was a secondary variable. Results. After 12 and 24 weeks on therapy, the rates of patients treated with poli + AS (10/46, 21.7% and 32/46, 69.6%, respectively) who achieved mRSs ≤1 were significantly (p0.01 and p0.0001, respectively) greater than those treated with pla + AS (0/46, 0.0% and 7/46, 15.2%, respectively). Poli + AS treatment given for 6 weeks reduced significantly (p0.00001 vs baseline, p0.01 vs pla + AS) the mean mRSs value (24.1%), and this effect improved thereafter, so that it was reduced by 31.0% and 55.2% after 12 and 24 weeks on therapy, respectively. Poli + AS treatment also reduced significantly arachidonic acid-and adenosine diphosphateinduced platelet aggregation by 41.0% and 24.8%, respectively. Treatments were well tolerated. There were not withdrawals due to adverse experiences. Conclusions. In patients with recent ischemic stroke, poli + AS treatment improved the neurological recovery and decreased platelet aggregation as compared to pla + AS.

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“…The consolidated list of health claims pursuant to Article 13 of Regulation (EC) No 1924No /2006 submitted by Member States contains main entry claims with corresponding conditions of use and literature for similar health claims. EFSA has screened all health claims contained in the original consolidated list of Article 13 health claims which was received by EFSA in 2008 using six criteria established by the NDA Panel to identify claims for which EFSA considered sufficient information had been provided for evaluation and those for which more information or clarification was needed before evaluation could be carried out 5 .…”

Section: Information As Provided In the Consolidated Listmentioning

confidence: 99%

Scientific Opinion on the substantiation of health claims related to policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations (ID 1747, 1748, 1864, 1951, 1954, 4693) and maintenance of normal blood HDL-cholesterol co

Products¹

2011

EFSA Journal

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SUMMARYFollowing a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924No /2006. This opinion addresses the scientific substantiation of health claims in relation to policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations and maintenance of normal blood HDL-cholesterol concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claims is policosanols from sugar cane wax. The Panel considers that policosanols from sugar cane wax are sufficiently characterised. Maintenance of normal blood LDL-cholesterol concentrationsThe claimed effects are "cholesterol", "support for healthy blood lipid levels", and "cardiovascular system". The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal blood In weighing the evidence, the Panel took into account that the results from human intervention studies which assessed the effects of policosanols from sugar cane wax on total and LDL-cholesterol concentrations were inconsistent, and that no evidence for a mechanism by which policosanols from sugar cane wax could exert the claimed effect has been provided.On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations. Maintenance of normal blood HDL-cholesterol concentrationsThe claimed effects are "cholesterol", "support for healthy blood lipid levels", and "cardiovascular system". The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal HDL-cholesterol concentrations. The Panel considers that maintenance of normal HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.In weighing the evidence, the Panel took into account that the results from human intervention studies which assessed the effects of policosanols from sugar cane wax on HDL-cholesterol concentrations were inconsistent, and that no evidence for a mechanism by which policosanols from sugar cane wax could exert the claimed effect has been provided.On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of policosanols from sugar cane wax and maintenance of normal blood HDL-cholesterol concentrations.

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Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia

Abstract: clinicaltrials.gov Identifier: NCT00288483.

Cited by 152 publications

References 26 publications

The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in rats

The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in rats

Effects of policosanol on the recovery of ischemic stroke: a randomized controlled study

Scientific Opinion on the substantiation of health claims related to policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations (ID 1747, 1748, 1864, 1951, 1954, 4693) and maintenance of normal blood HDL-cholesterol co

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