724    

Background:  Epidemiologic and clinical trials indicate omega-3 fatty acids (fish oil) reduce triglycerides and cardiovascular disease in HIV-uninfected populations. The AHA recommends 2 to 4 g of fish oil for triglyceride reduction. The efficacy and safety of fish oil for HIV-associated hypertriglyceridemia is not known.

Methods:  Prospective, open-label, randomized trial for HIV⁺ adults on stable HAART, fasting (>8 hours) triglycerides 200 to 2000 mg/dL and no history of diabetes mellitus were assigned to nutritionist-administered AHA-based diet/exercise counseling (week 0 and 4) alone vs with 3 g of fish oil daily (1150 mg DHA, 1750 mg EPA, Coromega Inc) for 16 weeks. Fasting triglycerides (TG) and total cholesterol (TC), HDL-C, direct LDL-C (Atherotech Inc), Lp(a), 2-hour OGTT, platelet function assays and self-report adherence were evaluated at week 0, 4, and 16. Intra-arm analysis of the change in triglycerides assumed a ≥15% drop from baseline as significant.

Results:  Of the 52 patients who were randomized, 7 were lost to follow-up. Of the remaining patients, 90% were male, 56% non-white, mean age = 43. Baseline mean triglyceride level in the Fish Oil arm = 454 mg/dLą342 (n = 27) and in Diet/Exercise arm = 552 mg/dLą539 (n = 23); mean body mass index = 27.4 kg/m², CD4 = 526/mm³, HIV RNA = 34,366 copies/mL. Comparison of triglyceride change from baseline to week 4 and 16 following log transformation found no difference between arms at either time point (p = 0.10, p = 0.16, respectively), although, mean triglycerides without log transformation suggested a trend favoring the Fish Oil arm as shown below:

The percentage of patients with week 4 triglycerides <200 mg/dL was 36% in the Fish Oil arm vs 11% in the Diet/Exercise arm (p = 0.046) but at week 16 was 27% and 24%, respectively (p = 0.28). There was no difference between arms in the change from baseline at week 4 or 16 in total cholesterol, direct LDL-C, Lp(a), 2-hour OGTT, or insulin. Self-report adherence was excellent. Fish oil was well tolerated with no serious adverse events, treatment-limiting toxicities, or effect on platelet function. HIV RNA and CD4 counts did not significantly change during fish oil therapy.

Conclusions:  At the dose studied, fish oil was well tolerated but when combined with diet and exercise, resulted in modest improvement in HIV-associated hypertriglyceridemia that is unlikely to be clinically significant.

Keywords: Hypertriglyceridemia; Fish oil; Omega-3-fatty acids