Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148.

TitleSafety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148.
Publication TypeJournal Article
Year of Publication2006
AuthorsDubé MP, Wu JW, Aberg JA, Deeg MA, Alston-Smith BL, McGovern ME, Lee D, Shriver SL, Martinez AI, Greenwald M, Stein JH
Corporate AuthorsAIDS Clinical Trials Group A5148 Study Team
JournalAntivir Ther
Volume11
Issue8
Pagination1081-9
Date Published2006
ISSN1359-6535
KeywordsAdult, Blood Glucose, Delayed-Action Preparations, Dyslipidemias, HIV Infections, Humans, Hypolipidemic Agents, Male, Middle Aged, Niacin, Triglycerides
Abstract

BACKGROUND: Dyslipidaemia is very common in patients with HIV infection, but current therapies are often suboptimal. Since niacin may cause insulin resistance and hepatotoxicity, it has generally been avoided in this setting.

METHODS: Non-diabetic male subjects (n=33) who had well-controlled HIV infection on antiretroviral therapy, fasting triglycerides > or =2.26 mmol/l and non-high density lipoprotein cholesterol (non-HDL-C) > or =4.66 mmol/l received escalating doses of extended-release niacin (ERN) up to 2,000 mg nightly for up to 44 weeks.

RESULTS: Fourteen subjects (42%) had pre-diabetes at entry. Twenty-three subjects (70%) received the maximum dose, eight (24%) received 1,500 mg. Niacin was well-tolerated. Only four subjects (12%) discontinued study treatment. There were small increases in fasting glycaemia and insulin resistance estimated by the homeostasis model assessment, but insulin resistance measures from the 2-h oral glucose tolerance test only transiently worsened. No subject developed persistent fasting hyperglycaemia; one had persistently elevated 2-h glucose >11.1 mmol/l. There were no significant changes in serum transaminases or uric acid. At week 48, the median change in fasting lipid levels in mmol/l (interquartile range) were: total cholesterol -0.21 (-1.35, -0.05), HDL-C +0.013 (-0.03,+0.28), non-HDL-C -0.49 (-1.37,+0.08) and triglycerides -1.73 (-3.68, -0.72). Favourable changes in large HDL and large very low density lipoprotein particle concentration were observed by nuclear magnetic resonance spectroscopy.

CONCLUSIONS: ERN in doses up to 2,000 mg daily was safe, well-tolerated and efficacious in HIV-infected subjects with atherogenic dyslipidaemia. Increases in glycaemia and insulin resistance tended to be transient.

Alternate JournalAntivir. Ther. (Lond.)
PubMed ID17302378
PubMed Central IDPMC2288649
Grant ListAI-25859 / AI / NIAID NIH HHS / United States
AI-27663 / AI / NIAID NIH HHS / United States
AI-38855 / AI / NIAID NIH HHS / United States
AI-38858 / AI / NIAID NIH HHS / United States
AI25859 / AI / NIAID NIH HHS / United States
AI27661 / AI / NIAID NIH HHS / United States
AI27670 / AI / NIAID NIH HHS / United States
AI27675 / AI / NIAID NIH HHS / United States
RR-00070 / RR / NCRR NIH HHS / United States
RR-00750 / RR / NCRR NIH HHS / United States
U01 AI027665 / AI / NIAID NIH HHS / United States
U01 AI027665-18 / AI / NIAID NIH HHS / United States
U01 AI027665-18S1 / AI / NIAID NIH HHS / United States
U01 AI027665-18S2 / AI / NIAID NIH HHS / United States