title: Naltrexone/Bupropion extended release-induced weight loss is independent of nausea in subjects without diabetes.
abstract: Naltrexone/bupropion extended release (NB) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of ≥30 or ≥27 kg m(-2) and ≥1 weight-related comorbidity (e.g. hypertension, type 2 diabetes and dyslipidaemia). In phase 3 clinical studies, nausea occurred in significantly higher proportions of subjects randomized to NB vs. placebo (PBO). In this pooled analysis of three phase 3, 56-week, PBO-controlled studies, we characterized nausea and weight loss in NB- and PBO-treated subjects without diabetes. Subjects receiving NB (n = 1778) lost significantly more weight than those receiving PBO (n = 1160). Weight change was not significantly different between subjects reporting and not reporting nausea in either treatment arm. Severity of nausea was mild to moderate in ≥95% of all cases. In the NB arm, the highest incidence of nausea onset (9%) was reported during week 1. The median duration of mild, moderate and severe nausea in subjects receiving NB was 14, 9 and 13 days, respectively. Our results demonstrate that nausea associated with NB is rarely severe, primarily occurs early in treatment and is not a contributor to weight loss.
authors.affiliation: Center for Clinical Nutrition & Applied Health Research, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. kurthong@med.usc.edu.
authors.forename: K
authors.initials: K
authors.lastname: Hong
authors.affiliation: US Medical Affairs Department, Takeda Pharmaceuticals USA Inc., Deerfield, IL, USA.
authors.forename: K
authors.initials: K
authors.lastname: Herrmann
authors.affiliation: US Medical Affairs Department, Takeda Pharmaceuticals USA Inc., Deerfield, IL, USA.
authors.forename: C
authors.initials: C
authors.lastname: Dybala
authors.affiliation: Clinical Development Department, Orexigen Therapeutics, La Jolla, CA, USA.
authors.forename: A E
authors.initials: AE
authors.lastname: Halseth
authors.affiliation: Quantitative Science Department, Takeda Development Center Americas Inc., Deerfield, IL, USA.
authors.forename: H
authors.initials: H
authors.lastname: Lam
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Foreyt
mesh_terms: D000328:Adult; D019440:Anti-Obesity Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015992:Body Mass Index; D016642:Bupropion / Q000009:adverse effects* / Q000627:therapeutic use; D003131:Combined Modality Therapy / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000009:adverse effects; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D006973:Hypertension / Q000209:etiology / Q000517:prevention & control; D015994:Incidence; D059012:Lost to Follow-Up; D008297:Male; D009271:Naltrexone / Q000009:adverse effects* / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology / Q000628:therapy; D050177:Overweight / Q000188:drug therapy* / Q000503:physiopathology / Q000628:therapy; D010352:Patient Dropouts; D012720:Severity of Illness Index; D014481:United States / Q000453:epidemiology; D015431:Weight Loss / Q000187:drug effects
chemical_list: D019440:Anti-Obesity Agents; D003692:Delayed-Action Preparations; D016642:Bupropion; D009271:Naltrexone
keywords: Adverse events; naltrexone/bupropion extended release; nausea; obesity