Policosanol for managing human immunodeficiency virus-related dyslipidemia in a medically underserved population: a randomized, controlled clinical trial.

Abstract

BACKGROUND:

Human immunodeficiency virus (HIV) infection is associated with dyslipidemia and increased risk for cardiovascular events; however, the use ofstatins in HIV-infected people is complicated by pharmacokinetic interactions and overlapping toxicities with antiretroviral medications. Policosanol is a dietary supplement derived from sugar cane that is widely used as a statin alternative in Latin America.

PRIMARY STUDY OBJECTIVE:

To collect feasibility data on sugar cane-derived policosanol to normalize dyslipidemic profiles in a sample of medically underserved HIV-infected people.

METHODS/DESIGN:

Randomized, controlled, double-blind clinical trial.

SETTING:

Two infectious disease outpatient clinics located in a Health Resources Service Administration-designated medically underserved neighborhood in Chicago, Illinois.

PARTICIPANTS:

Fifty-four clinically stable HIV-infected people (91% black) with at least one lipid abnormality that warranted dietary modifications and/or drug therapy.

INTERVENTION:

Participants received either 20 mg/day of policosanol or placebo for 12 weeks, followed by a 4-week washout and crossover to the other arm.

PRIMARY OUTCOME MEASURES:

Efficacy measures included the standard lipid panel (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) and nuclear magnetic resonance (NMR)-derived lipoprotein particle profiles. Safety measures included CD4+ T lymphocyte counts, plasma HIV ribonucleic acid levels, serum creatinine, and liver function tests.

RESULTS:

Policosanol supplementation was not associated with normalization of any dyslipidemic parameters as measured by the standard lipid panel or NMR spectroscopy-measured lipoprotein size or concentration. The supplement was well tolerated and was not associated with any changes in parameters of HIV disease progression.

CONCLUSIONS:

Our findings corroborate recent studies conducted outside Cuba that have failed to find any lipid modulatory effects for policosanol.

• Authors: Barbara Swanson, Joyce K Keithley, Beverly E Sha, Louis Fogg, Judith Nerad, Richard M Novak, Oluwatoyin Adeyemi, Gregory T Spear
• Journal: Alternative therapies in health and medicine (Altern Ther Health Med) 2011 Mar-Apr Vol. 17 Issue 2 Pg. 30-5 ISSN: 1078-6791 [Print] United States
• PMID: 21717822 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Cholesterol, HDL
• Cholesterol, LDL
• Fatty Alcohols
• Triglycerides
• policosanol

Topics

• Adult
• Anticholesteremic Agents (administration & dosage)
• Antiretroviral Therapy, Highly Active (adverse effects)
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Cross-Over Studies
• Double-Blind Method
• Dyslipidemias (chemically induced, drug therapy)
• Fatty Alcohols (administration & dosage)
• Female
• HIV Infections (complications, drug therapy)
• Humans
• Male
• Medically Underserved Area
• Middle Aged
• Severity of Illness Index
• Treatment Failure
• Triglycerides (blood)