7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 13–16 November 2005, Dublin, Ireland

Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: a prospective, multicentre study (ACTG 5148)

MP Dubé¹, JW Wu², JA Aberg³, MA Deeg¹, ME McGovern⁴, BL Alston⁵, SL Shriver⁶, ML Greenwald¹, D Lee⁷ and JH Stein^8
1Indiana University, Indianapolis, IN, USA; ²Statistical and Data Analysis Centre, Harvard University, Boston, MA, USA; ³New York University, New York, NY, USA; ⁴Kos Pharmaceuticals, Weston, FL, USA; ⁵NIH, Bethesda, MD, USA; ⁶Social & Scientific Systems Inc., Silver Spring, MD, USA; ⁷University of California, San Diego, CA, USA; ⁸University of Wisconsin, Madison, WI, USA

Antiviral Therapy 2005; Supplement 3:L9 (abstract no. 12)

BACKGROUND: Guidelines suggest using statins and fibrates in patients on antiretroviral therapy (ART), but the effectiveness of these agents is limited, even in combination. Because niacin may cause insulin resistance and hepatotoxicity, it has been avoided as a first-line agent in HIV infection. The purpose of this study was to determine if extended-release niacin (ERN) is safe and effective in dyslipidaemic patients with HIV infection on ART.

METHODS: This was a 48-week, multicentre, open-label study in subjects with triglycerides >200mg/dl and nonhigh-density lipoprotein cholesterol (non-HDL-C) >180 mg/dl. After a dietary run-in, subjects received ERN (Niaspan, Kos Pharmaceuticals, Weston, FL, USA) with 500 mg dose titrations every 4–6 weeks as tolerated to a target dose of 2000 mg daily or to a composite lipid goal of non-HDL-C <160mg/dl, LDL <130mg/dl and triglycerides <500mg/dl.

RESULTS: ERN was well-tolerated. Of 33 subjects (median age 43 years, 67% white, all male), all but one completed the study. Twenty-three subjects received the 2000 mg dose of ERN, eight received 1500 mg. No significant changes were seen in aminotransferase or uric acid levels (all P trend>0.14). At week 12, fasting glucose levels increased transiently (median change +4.5 mg/dl [5%], P=0.03) but changes were not significant at weeks 24 or 48 (final median change 0 mg/dl, P trend=0.36). Median (interquartile range) lipid levels (mg/dl) and changes from baseline (all P <0.01) are in the Table.

CONCLUSIONS: ERN at doses up to 2000mg/day is a safe, well-tolerated and effective agent for treating dyslipidaemia in HIV-infected individuals receiving ART.

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2005-11-13
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