title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors.affiliation: Translational Metabolism Unit, Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Houston, Texas 77030, USA. ashokb@bcm.edu
authors.forename: Ashok
authors.initials: A
authors.lastname: Balasubramanyam
authors.forename: Ivonne
authors.initials: I
authors.lastname: Coraza
authors.forename: E O'Brian
authors.initials: EO
authors.lastname: Smith
authors.forename: Lynne W
authors.initials: LW
authors.lastname: Scott
authors.forename: Payal
authors.initials: P
authors.lastname: Patel
authors.forename: Dinakar
authors.initials: D
authors.lastname: Iyer
authors.forename: Addison A
authors.initials: AA
authors.lastname: Taylor
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Giordano
authors.forename: Rajagopal V
authors.initials: RV
authors.lastname: Sekhar
authors.forename: Pamela
authors.initials: P
authors.lastname: Clark
authors.forename: Edith
authors.initials: E
authors.lastname: Cuevas-Sanchez
authors.forename: Swarna
authors.initials: S
authors.lastname: Kamble
authors.forename: Christie M
authors.initials: CM
authors.lastname: Ballantyne
authors.forename: Henry J
authors.initials: HJ
authors.lastname: Pownall
mesh_terms: D052242:Adiponectin / Q000097:blood*; D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D015444:Exercise; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D006679:HIV Seropositivity / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000960:Hypolipidemic Agents; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000627:therapeutic use*; D040242:Risk Reduction Behavior; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D052242:Adiponectin; D044966:Anti-Retroviral Agents; D000960:Hypolipidemic Agents; D014280:Triglycerides; D009525:Niacin; D011345:Fenofibrate