title: Patient-reported quality of life in a randomized placebo-controlled trial of naltrexone/bupropion for obesity.
abstract: Weight loss is associated with improved quality of life in some, but not all, weight loss trials. We evaluated changes at 56 weeks in quality of life, measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, in a pooled analysis of patient-level data from four randomized controlled Phase 3 studies of naltrexone/bupropion (NB32 or Contrave®). The total number of subjects was 3362 (NB32 = 2043; placebo = 1319; mean body mass index = 36.3 kg m(2); mean age = 46). Improvements in IWQOL-Lite Total Score were greater in subjects treated with NB32 (11.9 points [SE 0.3]) vs. placebo (8.2 points [SE 0.3]; P < 0.001), corresponding to weight reductions of 7.0% (SE 0.2) and 2.3% (SE 0.2), respectively. Greater improvements were also observed for NB32 vs. placebo on all five subscale scores of the IWQOL-Lite. Fifty per cent of NB32-treated subjects achieved clinically meaningful improvements in IWQOL-Lite Total Score vs. 32.3% of placebo-treated subjects (odds ratio, 95% confidence interval; 2.09, 1.79-2.44). Subjects losing the most weight (≥ 15% of baseline weight) experienced the greatest improvement in IWQOL-Lite Total Score (19.3 points [SE 0.7] for NB32 and 18.7 points [SE 1.3] for placebo; P = 0.624). Improved quality of life was associated with weight reduction and was achieved in more subjects treated with NB32 than placebo.
authors.affiliation: Quality of Life Consulting, Durham, NC, USA.|Department of Community and Family Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Kolotkin
authors.affiliation: Takeda Pharmaceuticals, Deerfield, IL, USA.
authors.forename: S
authors.initials: S
authors.lastname: Chen
authors.affiliation: Orexigen Therapeutics, La Jolla, CA, USA.
authors.forename: P
authors.initials: P
authors.lastname: Klassen
authors.affiliation: Orexigen Therapeutics, La Jolla, CA, USA.
authors.forename: K
authors.initials: K
authors.lastname: Gilder
authors.affiliation: Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA.
authors.forename: F L
authors.initials: FL
authors.lastname: Greenway
mesh_terms: D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D016642:Bupropion / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy* / Q000523:psychology*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015431:Weight Loss; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D004338:Drug Combinations; C000591595:bupropion hydrochloride, naltrexone hydrochoride drug combination; D016642:Bupropion; D009271:Naltrexone
keywords: Contrave®; IWQOL-Lite; quality of life; weight loss