Evidence map›Paper›PMID 36968652›Full record

ArticleNEJM evidence2022

Phentermine/Topiramate for the Treatment of Adolescent Obesity.

Aaron S Kelly, Megan O Bensignor, Daniel S Hsia, Ashley H Shoemaker, Winnie Shih, Craig Peterson, Santosh T Varghese

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in NEJM evidence, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03922945 (A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents), which is not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 3 pooled it
23.7field-weighted citation impact, top 1% 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.

NCT03922945 phase4completednot on this map

A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents

TypeinterventionalSponsorVIVUS LLCRan2019 to 2021Enrolled223ConditionsAdolescent Obesity, Obesity in Adolescence, Adolescent OverweightArmsVI-0521 oral capsule, Placebo oral capsule, Lifestyle Modification
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 3 syntheses or guidelines pooled it, 147 citations in OpenAlex.

  1. Pooled it
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  8. Once-Weekly Semaglutide in Adolescents with Obesity.The New England journal of medicine · 2022 · on this map
    Trial
  9. Review
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  15. Management of Childhood Obesity.International journal of molecular sciences · 2026
    Review
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14 more citing papers are in PubMed but not listed here.

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

7 authors at 3 institutions in 1 country.

Aaron S KellyDepartment of Pediatrics, Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis.
Megan O BensignorDepartment of Pediatrics, Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis.
Daniel S HsiaPennington Biomedical Research Center, Baton Rouge, LA.
Ashley H ShoemakerDivision of Pediatric Endocrinology, Vanderbilt University Medical Center, Nashville.
Winnie ShihVIVUS LLC, Campbell, CA.
Craig PetersonVIVUS LLC, Campbell, CA.
Santosh T VargheseVIVUS LLC, Campbell, CA.
University of Minnesota Medical Center · USPennington Biomedical Research Center · USVanderbilt University Medical Center · US

Funding

Anti-obesity pharmacotherapy to decrease BMI and improve insulin sensitivity in adolescents with obesity and type 2 diabetesK23DK129721 · NIDDK · UNIVERSITY OF MINNESOTA · PI BENSIGNOR, MEGAN O · 2021 to 2025
$1.0M
NIDDK NIH HHS K23 DK129721
6 · The paper itself

Abstract

backgroundAntiobesity medication may be useful for the treatment of pediatric obesity, yet few safe and effective options exist. We evaluated phentermine/topiramate (PHEN/TPM) for weight management in adolescents with obesity.

methodsThis 56-week, randomized, double-blind trial enrolled adolescents 12 to less than 17 years of age with obesity. Participants were randomly assigned 1:1:2 to receive either placebo (n=56), mid-dose PHEN/TPM (7.5 mg/46 mg; n=54), or top-dose PHEN/TPM (15 mg/92 mg; n=113), respectively. All participants received lifestyle therapy. The primary end point was mean percent change in body-mass index (BMI) from randomization to week 56.

resultsParticipants had a mean (±SD) age of 14.0±1.4 years and a mean (±SD) BMI of 37.8±7.1 kg/m

conclusionsPHEN/TPM at both the mid and top doses offered a statistically significant reduction in BMI and favorably impacted triglyceride and HDL-C levels in adolescents with obesity. (Funded by VIVUS LLC, with project support provided by Covance LLC; ClinicalTrials.gov number, NCT03922945.).

Identifiers

PMID36968652
PMCPMC10035585
OpenAlexW4225146163

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.