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

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.