Comparative lipid-lowering effects of policosanol and atorvastatin

A randomized, parallel, double-blind, placebo-controlled trial

Luigi X. Cubeddu, Roberto J. Cubeddu, Todd Heimowitz, Beatriz Restrepo, Gervasio A. Lamas, Gloria B. Weinberg

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background: Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. Methods: A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. Results: A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Conclusions: Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.

Original languageEnglish
JournalAmerican Heart Journal
Volume152
Issue number5
DOIs
StatePublished - Nov 1 2006
Externally publishedYes

Fingerprint

policosanol
Placebos
Lipids
LDL Cholesterol
Cholesterol
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Canes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Comparative lipid-lowering effects of policosanol and atorvastatin : A randomized, parallel, double-blind, placebo-controlled trial. / Cubeddu, Luigi X.; Cubeddu, Roberto J.; Heimowitz, Todd; Restrepo, Beatriz; Lamas, Gervasio A.; Weinberg, Gloria B.

In: American Heart Journal, Vol. 152, No. 5, 01.11.2006.

Research output: Contribution to journalArticle

Cubeddu, Luigi X. ; Cubeddu, Roberto J. ; Heimowitz, Todd ; Restrepo, Beatriz ; Lamas, Gervasio A. ; Weinberg, Gloria B. / Comparative lipid-lowering effects of policosanol and atorvastatin : A randomized, parallel, double-blind, placebo-controlled trial. In: American Heart Journal. 2006 ; Vol. 152, No. 5.
@article{e7738ba0dbef4c9d956105f915f580b9,
title = "Comparative lipid-lowering effects of policosanol and atorvastatin: A randomized, parallel, double-blind, placebo-controlled trial",
abstract = "Background: Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. Methods: A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. Results: A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27{\%} and LDL-C by 35{\%}. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Conclusions: Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.",
author = "Cubeddu, {Luigi X.} and Cubeddu, {Roberto J.} and Todd Heimowitz and Beatriz Restrepo and Lamas, {Gervasio A.} and Weinberg, {Gloria B.}",
year = "2006",
month = "11",
day = "1",
doi = "10.1016/j.ahj.2006.08.009",
language = "English",
volume = "152",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Comparative lipid-lowering effects of policosanol and atorvastatin

T2 - A randomized, parallel, double-blind, placebo-controlled trial

AU - Cubeddu, Luigi X.

AU - Cubeddu, Roberto J.

AU - Heimowitz, Todd

AU - Restrepo, Beatriz

AU - Lamas, Gervasio A.

AU - Weinberg, Gloria B.

PY - 2006/11/1

Y1 - 2006/11/1

N2 - Background: Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. Methods: A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. Results: A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Conclusions: Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.

AB - Background: Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. Methods: A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. Results: A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Conclusions: Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.

UR - http://www.scopus.com/inward/record.url?scp=33750407566&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33750407566&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2006.08.009

DO - 10.1016/j.ahj.2006.08.009

M3 - Article

VL - 152

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 5

ER -