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.
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).
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Published: 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.