Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: Results of "Heart Positive," a randomized, controlled trial

Ashok Balasubramanyam, Ivonne Coraza, E. O.Brian Smith, Lynne W. Scott, Payal Patel, Dinakar Iyer, Addison A. Taylor, Thomas P. Giordano, Rajagopal V. Sekhar, Pamela Clark, Edith Cuevas-Sanchez, Swarna Kamble, Christie M. Ballantyne, Henry J. Pownall

Research output: Contribution to journalArticle

46 Scopus citations

Abstract

Context: HIV patients on antiretroviral therapy (ART) have a unique dyslipidemia [elevated triglycerides and non-high-density lipoprotein- cholesterol (HDL-C) , low HDL-C] with insulin resistance (characterized by hypoadiponectinemia). Objective: The aim was to test a targeted, comprehensive, additive approach to treating the dyslipidemia. Design and Setting: We conducted a randomized, double-blind, placebo-controlled, 24-wk trial of lifestyle modification, fenofibrate, and niacin in multiethnic HIV clinics at an academic center. Participants: Hypertriglyceridemic adult patients were stratified on three combinations of ART classes. Subjects retained at the first measurement (2 wk) after entry were included in the analysis (n = 191). Interventions: Subjects were randomized into five treatment groups: usual care (group 1); low-saturated-fat diet and exercise (D/E; group 2); D/E + fenofibrate (group 3); D/E + niacin (group 4); or D/E + fenofibrate + niacin (group 5). Main Outcome Measures: We measured changes in fasting triglycerides, HDL-C, and non-HDL-C (primary), and in insulin sensitivity, glycemia, adiponectin, C-reactive protein, energy expenditure, and body composition (secondary). Data were analyzed as a factorial set of treatment combinations using a mixed repeated measures model, last observation carried forward, and complete case approaches (groups 2-5), and as an unstructured set of treatments (groups 1-5). Results: Fenofibrate improved triglycerides (P = 0.002), total cholesterol (P = 0.02), and non-HDL-C (P = 0.003), whereas niacin improved HDL-C (P = 0.03), and both drugs decreased the total cholesterol-to-HDL-C ratio (P = 0.005-0.01). The combination of D/E, fenofibrate, and niacin provided maximal benefit, markedly reducing triglycerides (-52% compared to usual care; P = 0.003), increasing HDL-C (+12%; P < 0.001), and decreasing non-HDL-C (-18.5%; P = 0.003) and total cholesterol-to-HDL-C ratio (-24.5%; P < 0.001). Niacin doubled adiponectin levels. Conclusions: A combination of fenofibrate and niacin with low-saturated-fat D/E is effective and safe in increasing HDL-C, decreasing non-HDL-C and hypertriglyceridemia, and ameliorating hypoadiponectinemia in patients with HIV/ART-associated dyslipidemia.

Original languageEnglish (US)
Pages (from-to)2236-2247
Number of pages12
JournalJournal of Clinical Endocrinology and Metabolism
Volume96
Issue number7
DOIs
StatePublished - Jul 1 2011

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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