title: Effects of metformin or gemfibrozil on the lipodystrophy of HIV-infected patients receiving protease inhibitors.
abstract: BACKGROUND
  Hypertriglyceridaemia and insulin resistance are common in HIV-infected patients treated with protease inhibitors, particularly in those with lipodystrophy. Whether a therapeutic approach addressed to those metabolic abnormalities may have any impact on body fat is not clear.
  
  
  METHODS
  Patients on stable antiretroviral therapy containing protease inhibitors, with abdominal obesity defined by increased waist-to-hip ratio, and plasma triglycerides >200 mg/dl, were randomized to receive blind medication consisting of metformin 850 mg, gemfibrozil 600 mg or placebo every 12 h for 1 year. Weight, height, waist and hip were measured, and fasting blood analyses, including at least CD4 cell count, plasma HIV-1 RNA, lactate, glucose, insulin, triglycerides, total, HDL and LDL cholesterol were performed at baseline and every 3 months. An oral glucose tolerance test, and assessments of total and regional fat by bioimpedance analysis and sonography, respectively, were also done at baseline, 6 and 12 months.
  
  
  RESULTS
  One-hundred-and-eight patients were randomized to placebo (n=36), gemfibrozil (n=37) or metformin (n=35). There was absolute loss of total and regional fat in the three arms without significant changes in the waist-to-hip ratio. However, the loss of fat in patients on gemfibrozil was significantly lower than in patients on placebo. No patient discontinued study drugs due to adverse effects.
  
  
  CONCLUSIONS
  In this population of HIV-infected patients, there was a loss of fat along time. The finding of relative preservation of fat associated with gemfibrozil therapy deserves further investigation in the search of potential effective therapies for lipodystrophy in HIV-infected subjects.
authors.affiliation: Hospital Clinic-IDIBAPS, Barcelona, Spain. esteban@fundsoriano.es
authors.forename: Esteban
authors.initials: E
authors.lastname: Martínez
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.forename: Ana
authors.initials: A
authors.lastname: Milinkovic
authors.forename: Juan A
authors.initials: JA
authors.lastname: Arroyo
authors.forename: Ignacio
authors.initials: I
authors.lastname: Conget
authors.forename: José B
authors.initials: JB
authors.lastname: Pérez-Cuevas
authors.forename: Roser
authors.initials: R
authors.lastname: Casamitjana
authors.forename: Elisa
authors.initials: E
authors.lastname: de Lazzari
authors.forename: Luis
authors.initials: L
authors.lastname: Bianchi
authors.forename: Enric
authors.initials: E
authors.lastname: Montserrat
authors.forename: Merce
authors.initials: M
authors.lastname: Roca
authors.forename: Rosa
authors.initials: R
authors.lastname: Burgos
authors.forename: Juan A
authors.initials: JA
authors.lastname: Arnaiz
authors.forename: José M
authors.initials: JM
authors.lastname: Gatell
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001824:Body Constitution; D004311:Double-Blind Method; D005260:Female; D015248:Gemfibrozil / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D017320:HIV Protease Inhibitors; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents; D008687:Metformin; D015248:Gemfibrozil