Evidence mapPaperPMID 28026920Full record

Trial reportObesity (Silver Spring, Md.)2017

Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity.

Amy Halseth, Kevin Shan, Brandon Walsh, Kye Gilder, Ken Fujioka

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 7% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Long-Term Weight Loss Strategies for Obesity.The Journal of clinical endocrinology and metabolism · 2021
    Review
  10. Review
  11. Article
  12. Article
  13. 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

5 authors at 2 institutions in 1 country.

Amy HalsethOrexigen Therapeutics, Inc, La Jolla, California, USA.
Kevin ShanOrexigen Therapeutics, Inc, La Jolla, California, USA.
Brandon WalshOrexigen Therapeutics, Inc, La Jolla, California, USA.
Kye GilderOrexigen Therapeutics, Inc, La Jolla, California, USA.
Ken FujiokaScripps Clinic, La Jolla, California, USA.
VistaGen Therapeutics (United States) · USScripps Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis 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.

methodsIn 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.

resultsNB + 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.

conclusionsTreatment 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.

Indexed as

AdolescentAdultBody WeightBupropionDelayed-Action PreparationsDopamine Uptake InhibitorsDouble-Blind MethodExerciseFeeding BehaviorFemaleHumansLife StyleMaleMiddle AgedNaltrexoneNarcotic AntagonistsBupropionDelayed-Action PreparationsDopamine Uptake InhibitorsNaltrexoneNarcotic Antagonists

Identifiers

PMID28026920
PMCPMC5299461
OpenAlexW2565880689

What Socratic holds

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LicenceCC BY-NC
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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.