Evidence map›Paper›PMID 27328752›Full record

Trial reportInternational journal of obesity (2005)2016

The relationship between early weight loss and weight loss at 1 year with naltrexone ER/bupropion ER combination therapy.

K Fujioka, R Plodkowski, P M O'Neil, K Gilder, B Walsh, F L Greenway

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of obesity (2005), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
7.0field-weighted citation impact, top 3% 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

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.

  1. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
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  20. Setting Expectations When Prescribing Medication for the Treatment of Patients With Obesity.Mayo Clinic proceedings. Innovations, quality & outcomes · 2025
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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 4 institutions in 1 country.

K FujiokaScripps Clinic, La Jolla, CA, USA.
R PlodkowskiScripps Clinic, La Jolla, CA, USA.
P M O'NeilWeight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
K GilderOrexigen Therapeutics, Inc., La Jolla, CA, USA.
B WalshOrexigen Therapeutics, Inc., La Jolla, CA, USA.
F L GreenwayPennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA.
Scripps Clinic · USVistaGen Therapeutics (United States) · USMedical University of South Carolina · USPennington Biomedical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesWeight management medications increase the likelihood that patients will achieve clinically meaningful improvements in cardiovascular, metabolic and other weight-related measures of health. However, the weight loss achieved with any weight management intervention can vary widely among individuals, and patients who do not respond to pharmacotherapy by achieving clinically meaningful weight loss should discontinue therapy. We characterized 1-year weight loss in the phase 3 clinical trial program of the weight management medication, naltrexone/bupropion 32/360 mg (NB), as well as the relationship between early weight loss and long-term weight loss, particularly with respect to participants who achieved the clinically recommended threshold of ⩾5% weight loss by Week 16. PARTICIPANTS/

methodsData from participants from each of the four phase 3, randomized, placebo-controlled, 56-week clinical trials with NB were pooled (modified intent-to-treat population; NB N=2043, Placebo N=1319). This exploratory analysis examined the relationship between participant achievement of various weight loss thresholds early in treatment (at Week 8, 12 or 16) and the associated weight loss at Week 56 (Completers population; NB N=1310, Placebo N=763).

resultsIn the NB participants who completed 1 year of treatment, weight loss of at least 5% at Week 16 (n=873) was associated with least-squares mean weight loss of 11.7% at Week 56 and 85% of these participants had Week 56 weight loss of ⩾5%. Eighty percent (95% confidence interval: 78-82%) of the participants who would, and would not, achieve ⩾5% weight loss at Week 56 were correctly identified using the clinically recommended threshold of ⩾5% at Week 16. Safety and tolerability of NB was similar to previously published reports.

conclusionsParticipants who meet the Week 16 threshold of ⩾5% weight loss are likely to maintain clinically significant weight loss after 1 year of treatment. Further evaluations are required to evaluate improvements in measures of cardiovascular and metabolic risk.

Indexed as

AdolescentAdultAnti-Obesity AgentsBupropionDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNaltrexoneObesityRisk FactorsTreatment OutcomeWeight LossYoung AdultAnti-Obesity AgentsBupropionNaltrexone

Identifiers

PMID27328752
OpenAlexW2470467325

What OpenQuestion holds

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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 OpenQuestion graph.