Evidence map›Paper›PMID 22158731›Full record

Trial reportThe American journal of clinical nutrition2012

Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study.

W Timothy Garvey, Donna H Ryan, Michelle Look, Kishore M Gadde, David B Allison, Craig A Peterson, Michael Schwiers, Wesley W Day, Charles H Bowden

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of clinical nutrition, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00796367 (A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study), which is not on this map. Cited by 273 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
273citing papers in PubMed, 17 pooled it
43.4field-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.

NCT00796367 phase3completednot on this map

A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.

TypeinterventionalSponsorVIVUS LLCRan2008 to 2010Enrolled676ConditionsObesityArmsVI-0521, Placebo
3 · Its place in the literature

Who cites it

273 citing papers in PubMed, 17 syntheses or guidelines pooled it, 694 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  9. Guideline
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  15. Guideline
  16. Guideline
  17. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline.The Journal of clinical endocrinology and metabolism · 2017 · on this map
    Guideline
  18. Trial
  19. Review
  20. Review

213 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

W Timothy GarveyDepartment of Nutrition Sciences, UAB Diabetes Research and Training Center, University of Alabama at Birmingham, 35294-3360, USA. garveyt@uab.edu
Donna H Ryan
Michelle Look
Kishore M Gadde
David B Allison
Craig A Peterson
Michael Schwiers
Wesley W Day
Charles H Bowden
Pennington Biomedical Research Center · US

Funding

NR4A Orphan Receptors And Insulin ResistanceR01DK083562 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GARVEY, W TIMOTHY · 2009 to 2012
$2.1M
CSRD VA I01 CX000432NIDDK NIH HHS R01 DK083562
6 · The paper itself

Abstract

backgroundObesity is a serious chronic disease. Controlled-release phentermine/topiramate (PHEN/TPM CR), as an adjunct to lifestyle modification, has previously shown significant weight loss compared with placebo in a 56-wk study in overweight and obese subjects with ≥2 weight-related comorbidities.

objectiveThis study evaluated the long-term efficacy and safety of PHEN/TPM CR in overweight and obese subjects with cardiometabolic disease.

designThis was a placebo-controlled, double-blind, 52-wk extension study; volunteers at selected sites continued with original randomly assigned treatment [placebo, 7.5 mg phentermine/46 mg controlled-release topiramate (7.5/46), or 15 mg phentermine/92 mg controlled-release topiramate (15/92)] to complete a total of 108 wk. All subjects participated in a lifestyle-modification program.

resultsOf 866 eligible subjects, 676 (78%) elected to continue in the extension. Overall, 84.0% of subjects completed the study, with similar completion rates between treatment groups. At week 108, PHEN/TPM CR was associated with significant, sustained weight loss (intent-to-treat with last observation carried forward; P < 0.0001 compared with placebo); least-squares mean percentage changes from baseline in body weight were -1.8%, -9.3%, and -10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more PHEN/TPM CR-treated subjects at each dose achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss compared with placebo (P < 0.001). PHEN/TPM CR improved cardiovascular and metabolic variables and decreased rates of incident diabetes in comparison with placebo. PHEN/TPM CR was well tolerated over 108 wk, with reduced rates of adverse events occurring between weeks 56 and 108 compared with rates between weeks 0 and 56.

conclusionPHEN/TPM CR in conjunction with lifestyle modification may provide a well-tolerated and effective option for the sustained treatment of obesity complicated by cardiometabolic disease. This trial was registered at clinicaltrials.gov as NCT00796367.

Indexed as

AdultAnti-Obesity AgentsCardiovascular DiseasesDelayed-Action PreparationsDiabetes MellitusDouble-Blind MethodDrug CombinationsFemaleFructoseHumansIncidenceIntention to Treat AnalysisLeast-Squares AnalysisMaleMetabolic DiseasesMiddle AgedAnti-Obesity AgentsDelayed-Action PreparationsDrug CombinationsFructosePhentermineTopiramate

Identifiers

PMID22158731
PMCPMC3260065
OpenAlexW2124477479

What OpenQuestion holds

Textmetadata
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.