title: Extended-Release Niacin Versus Fenofibrate in HIV-Infected Participants With Low High-Density Lipoprotein Cholesterol: Effects on Endothelial Function, Lipoproteins, and Inflammation.
abstract: BACKGROUND
  Low levels of high-density lipoprotein cholesterol (HDL-C) are common in individuals with human immunodeficiency virus (HIV) infection, persist during antiretroviral therapy (ART), and are associated with increased cardiovascular disease (CVD) risk.
  
  
  METHODS
  Virologically controlled participants without CVD on stable ART with low HDL-C (men <40 mg/dL, women <50 mg/dL) and triglycerides >150 mg/dL were randomized to receive open-label extended-release niacin 1500 mg/day with aspirin 325 mg/day or fenofibrate 200 mg/day for 24 weeks. The primary endpoint was the week 24 within-arm change in brachial artery flow-mediated dilation (FMD) in participants with complete follow-up scans.
  
  
  RESULTS
  Of 99 participants, 74 had complete data (35 niacin, 39 fenofibrate). Median age was 45 years, 77% were male, median CD4(+) count was 561 cells/µL, and brachial FMD was 4.2%. Median HDL-C was 32 mg/dL for men and 38 mg/dL for women, low-density lipoprotein cholesterol was 103 mg/dL, and triglycerides were 232 mg/dL. In men, HDL-C increased a median of 3 mg/dL with niacin and 6.5 mg/dL with fenofibrate (P < .001 for both). In women, HDL-C increased a median of 16 mg/dL with niacin and 8 mg/dL with fenofibrate (P = .08 for both). After 24 weeks, there was no significant change in FMD in either arm; the median (interquartile range) change was +0.6% (-1.6 to 2.3) with niacin (P = .28) and +0.5% (-1.0 to 3.0) with fenofibrate (P = .19). Neither treatment significantly affected C-reactive protein, interleukin 6, or D-dimer levels.
  
  
  CONCLUSIONS
  Despite improvements in lipids, niacin or fenofibrate treatment for 24 weeks did not improve endothelial function or inflammatory markers in participants with well-controlled HIV infection and low HDL-C.
  
  
  BACKGROUND
  NCT01426438.
authors.affiliation: University of Southern California Keck School of Medicine, Los Angeles.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Dubé
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Lauren
authors.initials: L
authors.lastname: Komarow
authors.affiliation: University of Cincinnati, Ohio.
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Fichtenbaum
authors.affiliation: University of Southern California Keck School of Medicine, Los Angeles.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Cadden
authors.affiliation: University of Alabama at Birmingham.
authors.forename: Edgar T
authors.initials: ET
authors.lastname: Overton
authors.affiliation: University of Southern California Keck School of Medicine, Los Angeles.
authors.forename: Howard N
authors.initials: HN
authors.lastname: Hodis
authors.affiliation: University of California at Los Angeles.
authors.forename: Judith S
authors.initials: JS
authors.lastname: Currier
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison.
authors.forename: James H
authors.initials: JH
authors.lastname: Stein
mesh_terms: D000328:Adult; D001916:Brachial Artery / Q000502:physiology; D002097:C-Reactive Protein; D008076:Cholesterol, HDL / Q000097:blood*; D003692:Delayed-Action Preparations; D050171:Dyslipidemias / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D004730:Endothelium, Vascular / Q000187:drug effects; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications / Q000453:epidemiology*; D006801:Humans; D007249:Inflammation; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*
chemical_list: D008076:Cholesterol, HDL; D003692:Delayed-Action Preparations; D008074:Lipoproteins; D009525:Niacin; D002097:C-Reactive Protein; D011345:Fenofibrate
keywords: HIV; endothelial function; fenofibrate; high-density lipoprotein; niacin