Evidence mapPaperPMID 27477337Full record

Trial reportClinical obesity2016

Naltrexone/Bupropion extended release-induced weight loss is independent of nausea in subjects without diabetes.

K Hong, K Herrmann, C Dybala, A E Halseth, H Lam, J P Foreyt

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical obesity, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Setting Expectations When Prescribing Medication for the Treatment of Patients With Obesity.Mayo Clinic proceedings. Innovations, quality & outcomes · 2025
    Review
  5. Naltrexone-bupropion for weight loss.Canadian family physician Medecin de famille canadien · 2023
    Article
  6. Review
  7. Obesity Pharmacotherapy in Patients With Type 2 Diabetes.Diabetes spectrum : a publication of the American Diabetes Association · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

K HongCenter for Clinical Nutrition & Applied Health Research, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. kurthong@med.usc.edu.
K HerrmannUS Medical Affairs Department, Takeda Pharmaceuticals USA Inc., Deerfield, IL, USA.
C DybalaUS Medical Affairs Department, Takeda Pharmaceuticals USA Inc., Deerfield, IL, USA.
A E HalsethClinical Development Department, Orexigen Therapeutics, La Jolla, CA, USA.
H LamQuantitative Science Department, Takeda Development Center Americas Inc., Deerfield, IL, USA.
J P ForeytBaylor College of Medicine, Houston, TX, USA.
Takeda (United States) · USBaylor College of Medicine · USDeerfield (United States) · USNewGen Therapeutics (United States) · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultAnti-Obesity AgentsBody Mass IndexBupropionCombined Modality TherapyDelayed-Action PreparationsDrug Therapy, CombinationDyslipidemiasFemaleHumansHypertensionIncidenceLost to Follow-UpMaleNaltrexoneNauseaAnti-Obesity AgentsBupropionDelayed-Action PreparationsNaltrexoneAdverse eventsnaltrexone/bupropion extended releasenauseaobesity

Identifiers

PMID27477337
PMCPMC5129540
OpenAlexW2494877622

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.