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The Effect of a 12-Week Course of Omega-3 Polyunsaturated Fatty Acids on Lipid Parameters in Hypertriglyceridemic Adult HIV-infected Patients Undergoing HAART: A Randomized, Placebo-Controlled Pilot Trial

Research output: Contribution to journalArticle

Barry S. Peters, Anthony S. Wierzbicki, Graeme Moyle, Devaki Nair, Norbert Brockmeyer

Original languageEnglish
Pages (from-to)67 - 76
Number of pages10
JournalClinical Therapeutics
Volume34
Issue number1
DOIs
Publication statusPublished - Jan 2012

King's Authors

Abstract

Background: Hypertriglyceridemia is common in patients with HIV treated with highly active antiretroviral therapy (HAART). Objective: The goal of this study was to investigate the effect of the polyunsaturated fatty acids (PUFA) docosahexaenoic acid (DHA) 460 mg/eicosapentaenoic acid (EPA) 380 mg on hypertriglyceridemia in HIV-treated patients. Methods: A double-blind, placebo-controlled, randomized, multicenter pilot study was undertaken in 48 evaluable HIV-infected patients undergoing HAART, with fasting triglyceride levels of 3.39 to 11.3 mmol/L. Patients were allowed fibrate or niacin but not statins and were randomized to PUFA 4 g daily versus placebo for 12 weeks. The primary end point was mean fasting triglyceride levels. Results: The study included 48 patients; 23 in the PUFA group (mean age, 46.1 years) and 25 in the placebo group (mean age, 43.6 years). All except one were male. All patients in the PUFA group were white; in the placebo group, 20 were white, 4 Asian, and 1 black. The PUFA group had a mean body mass index of 24.7 kg/m(2); the placebo group, 24.1 kg/m(2). All patients were receiving concomitant fibrate therapy. Median baseline triglyceride levels were 5.58 (1.76-10.6) mmol/L for the PUFA group and 4.29 (1.81-6.14) mmol/L for the placebo group. PUFA reduced triglycerides by a median of 1.75 mmol/L versus a 0.41 mmol/L increase for the placebo group (baseline-corrected percentage change relative to placebo [95% CI, -69.48% to -6.53%; P = 0.019). No effect was seen on biochemical or virologic safety parameters. No severe treatment-emergent adverse events (TEAEs) occurred. Mild and moderate TEAEs occurred in 20 PUFA-treated patients versus 19 patients receiving placebo. Five were adjudged treatment related, and one was due to cholelithiasis, which led to early discontinuation. Most TEAEs affected the gastrointestinal tract (DHA/EPA, n = 7; placebo, n = 4) and comprised diarrhea, nausea, and flatulence (DHA/EPA vs placebo: 3, 2, and 2 vs 2, 0, and 0, respectively). Conclusions: PUFA therapy with DHA/EPA reduced triglyceride levels significantly compared with placebo in HIV-infected patients with HAART-associated hypertriglyceridemia. ClinicalTrials.gov identifier: NCT00598910. (Clin Ther. 2012;34:67-.76) (C) 2012 Elsevier HS Journals, Inc. All rights reserved.

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