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- Title
Policosanol for Managing Human Immunodeficiency Virus-related Dyslipidemia in a Medically Underserved Population: A Randomized, Controlled Clinical Trial.
- Authors
Swanson, Barbara; Keithley, Joyce K.; Sha, Beverly E.; Fogg, Louis; Nerad, Judith; Novak, Richard M.; Adeyemi, Oluwatoyin; Spear, Gregory T.
- 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.
- Subjects
DYSLIPIDEMIA; HIV; RANDOMIZED controlled trials; ANTIRETROVIRAL agents; DRUG therapy; LIPOPROTEINS
- Publication
Alternative Therapies in Health & Medicine, 2011, Vol 17, Issue 2, p30
- ISSN
1078-6791
- Publication type
Article