PMID- 28026920
OWN - NLM
STAT- MEDLINE
DCOM- 20170622
LR  - 20181202
IS  - 1930-739X (Electronic)
IS  - 1930-7381 (Print)
IS  - 1930-7381 (Linking)
VI  - 25
IP  - 2
DP  - 2017 Feb
TI  - Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body 
      weight in individuals with obesity.
PG  - 338-345
LID - 10.1002/oby.21726 [doi]
AB  - OBJECTIVE: This study assessed the effects of 32 mg naltrexone sustained release 
      (SR)/360 mg bupropion SR (NB) on body weight in adults with obesity, with 
      comprehensive lifestyle intervention (CLI), for 78 weeks. METHODS: In this phase 
      3b, randomized, open-label, controlled study, subjects received NB + CLI or usual 
      care (standard diet/exercise advice) for 26 weeks. NB subjects not achieving 5% 
      weight loss at week 16 were discontinued, as indicated by product labeling. After 
      week 26, usual care subjects began NB + CLI. Assessments continued through week 
      78. The primary end point was percent change in weight from baseline to week 26 
      in the per protocol population. Other end points included percentage of subjects 
      achieving >/=5%, >/=10%, and >/=15% weight loss, percent change in weight at week 78, 
      and adverse events (AEs) necessitating study medication discontinuation. RESULTS: 
      NB + CLI subjects lost significantly more weight than usual care subjects at week 
      26 (8.52% difference; P < 0.0001). Weight loss persisted through 78 weeks. In 
      total, 20.7% of subjects discontinued medication for AEs, including 7.0% for 
      nausea. CONCLUSIONS: Treatment with NB, used as indicated by prescribing 
      information and with CLI, significantly improved weight loss over usual care 
      alone. NB-facilitated weight loss was sustained for 78 weeks and was deemed safe 
      and well tolerated.
CI  - (c) 2016 The Authors. Obesity published by Wiley Periodicals, Inc. onbehalf of The 
      Obesity Society (TOS).
FAU - Halseth, Amy
AU  - Halseth A
AD  - Orexigen Therapeutics, Inc, La Jolla, California, USA.
FAU - Shan, Kevin
AU  - Shan K
AD  - Orexigen Therapeutics, Inc, La Jolla, California, USA.
FAU - Walsh, Brandon
AU  - Walsh B
AD  - Orexigen Therapeutics, Inc, La Jolla, California, USA.
FAU - Gilder, Kye
AU  - Gilder K
AD  - Orexigen Therapeutics, Inc, La Jolla, California, USA.
FAU - Fujioka, Ken
AU  - Fujioka K
AD  - Scripps Clinic, La Jolla, California, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01764386
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161227
PL  - United States
TA  - Obesity (Silver Spring)
JT  - Obesity (Silver Spring, Md.)
JID - 101264860
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dopamine Uptake Inhibitors)
RN  - 0 (Narcotic Antagonists)
RN  - 01ZG3TPX31 (Bupropion)
RN  - 5S6W795CQM (Naltrexone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Body Weight/*drug effects
MH  - Bupropion/*therapeutic use
MH  - Delayed-Action Preparations/*therapeutic use
MH  - Dopamine Uptake Inhibitors/*therapeutic use
MH  - Double-Blind Method
MH  - Exercise
MH  - Feeding Behavior
MH  - Female
MH  - Humans
MH  - Life Style
MH  - Male
MH  - Middle Aged
MH  - Naltrexone/*therapeutic use
MH  - Narcotic Antagonists/*therapeutic use
MH  - Nausea
MH  - Obesity/*drug therapy
MH  - Weight Loss/drug effects
MH  - Young Adult
PMC - PMC5299461
EDAT- 2016/12/28 06:00
MHDA- 2017/06/24 06:00
PMCR- 2017/02/09
CRDT- 2016/12/28 06:00
PHST- 2016/08/30 00:00 [received]
PHST- 2016/10/28 00:00 [revised]
PHST- 2016/11/02 00:00 [accepted]
PHST- 2016/12/28 06:00 [pubmed]
PHST- 2017/06/24 06:00 [medline]
PHST- 2016/12/28 06:00 [entrez]
PHST- 2017/02/09 00:00 [pmc-release]
AID - OBY21726 [pii]
AID - 10.1002/oby.21726 [doi]
PST - ppublish
SO  - Obesity (Silver Spring). 2017 Feb;25(2):338-345. doi: 10.1002/oby.21726. Epub 
      2016 Dec 27.