title: Combination therapy with naltrexone and bupropion for obesity reduces total and visceral adiposity.
abstract: The effects of combination naltrexone/bupropion therapy on body composition and visceral adipose tissue (VAT) mass were examined in a subset (n = 107) of obese subjects from a Phase 2 trial that compared the efficacy and safety of placebo, naltrexone monotherapy, bupropion monotherapy or one of three naltrexone/bupropion dose combinations for 24 weeks. Body composition data were obtained using dual-energy X-ray absorptiometry and computed tomography. Eighty subjects completed the substudy. Naltrexone/bupropion resulted in weight loss and a greater reduction in body fat (-14.0 ± 1.3%) than placebo (-4.0 ± 2.0%), naltrexone monotherapy (-3.2 ± 2.5%) and bupropion monotherapy (-4.1 ± 2.9%; all p < 0.01). Reduction in VAT mass was also greater with naltrexone/bupropion (-15.0 ± 1.8%) than placebo (-4.6 ± 2.7%), naltrexone monotherapy (-0.1 ± 3.5%) and bupropion monotherapy (-2.3 ± 4.2%; all p < 0.01). Reductions in body fat and VAT mass with naltrexone/bupropion were proportional with weight loss. Weight loss with naltrexone/bupropion was not associated with a greater relative reduction in lean mass than placebo or the monotherapies.
authors.affiliation: Translational Research Institute for Metabolism and Diabetes, Florida Hospital/Burnham Institute, Winter Park, FL 32789, USA. Steven.R.Smith.MD@flhosp.org
authors.forename: S R
authors.initials: SR
authors.lastname: Smith
authors.forename: K
authors.initials: K
authors.lastname: Fujioka
authors.forename: A K
authors.initials: AK
authors.lastname: Gupta
authors.forename: S K
authors.initials: SK
authors.lastname: Billes
authors.forename: C
authors.initials: C
authors.lastname: Burns
authors.forename: D
authors.initials: D
authors.lastname: Kim
authors.forename: E
authors.initials: E
authors.lastname: Dunayevich
authors.forename: F L
authors.initials: FL
authors.lastname: Greenway
mesh_terms: D015502:Absorptiometry, Photon; D050154:Adiposity / Q000187:drug effects*; D000704:Analysis of Variance; D001823:Body Composition / Q000187:drug effects*; D016642:Bupropion / Q000008:administration & dosage / Q000627:therapeutic use*; D018765:Dopamine Uptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D050152:Intra-Abdominal Fat / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D018765:Dopamine Uptake Inhibitors; D016642:Bupropion; D009271:Naltrexone
keywords: adipose tissue; antiobesity drug; body composition; clinical trial; obesity therapy; weight loss therapy