Evidence map›Paper›PMID 23115402›Full record

Trial reportSleep2012

A randomized, double-blind, placebo-controlled study of an oral, extended-release formulation of phentermine/topiramate for the treatment of obstructive sleep apnea in obese adults.

David H Winslow, Charles H Bowden, Karen P DiDonato, Pamela A McCullough

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07577661 (Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea), which is not on this map. Cited by 60 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 5 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.

NCT07577661 phase1 / phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.

TypeinterventionalSponsorBrigham and Women's HospitalRan2026 to 2027Enrolled24ConditionsObstructive Sleep Apnea, Sleep-disordered BreathingArmsCombination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy), Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition, Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition, Placebo, placebo comparator condition
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 5 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. 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
  4. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2021
    Guideline
  5. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Pharmacotherapy in obstructive sleep apnoea: a clinical guide.Sleep & breathing = Schlaf & Atmung · 2026
    Review
  12. Current Updates on Pharmacotherapy for Obstructive Sleep Apnea.Journal of rhinology : official journal of the Korean Rhinologic Society · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

4 authors at 2 institutions in 1 country.

David H WinslowKentucky Research Group, Louisville, KY 40217, USA. dwinslow@kysleepmed.com
Charles H Bowden
Karen P DiDonato
Pamela A McCullough
Vivus (United States) · USKentucky Department of Education · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo evaluate safety and efficacy of phentermine 15 mg plus extended-release topiramate 92 mg for treatment of moderate to severe obstructive sleep apnea (OSA) in obese adults.

designThis phase 2, randomized, double-blind, placebo-controlled study included 2-week screening and 28-week treatment periods. Overnight polysomnography was performed at baseline, Week 8, and Week 28.

settingSingle-center study conducted from August 2008 to September 2009.

participantsForty-five subjects with moderate to severe OSA not receiving positive airway pressure (PAP) treatment with body mass index of 30-40 kg/m(2).

interventionsSubjects were randomized to receive placebo (n = 23) or phentermine 15 mg plus extended-release topiramate 92 mg (n = 22). Both groups received lifestyle-modification counseling. MEASUREMENTS AND

resultsPrimary endpoint, change in apnea-hypopnea index (AHI), significantly favored phentermine 15 mg plus extended-release topiramate 92 mg (-31.5 events/h, 95% CI: -40.0, -22.9) over placebo (-16.6 events/h, 95% CI: -25.0, -8.2) at Week 28 (P =0.0084). At Week 28, there was a 10.2% (95% CI: -12.7, -7.6; 10.8 kg, 95% CI: -13.5, -8.0) mean decrease in weight in the phentermine 15 mg plus extended-release topiramate 92 mg group compared with 4.3% (95% CI: -6.6, -2.0; 4.7 kg, 95% CI: -7.2, -2.2) in the placebo group (P = 0.0006) and a positive, significant (P = 0.0003) correlation between percent change in weight and change in AHI. Significant improvements in overnight oxygen saturation and reduction in blood pressure compared with placebo were observed. Phentermine 15 mg plus extended-release topiramate 92 mg was well tolerated with low adverse event rates.

conclusionsPhentermine 15 mg plus extended-release topiramate 92 mg induced significant weight reductions and concomitant improvements in OSA and related symptoms vs placebo. This suggests weight loss mediated by phentermine 15 mg plus extended-release topiramate 92 mg may be useful in treatment of moderate to severe OSA in obese subjects unable or unwilling to comply with PAP treatment.

Indexed as

Administration, OralAdultAgedAnti-Obesity AgentsAppetite DepressantsDelayed-Action PreparationsDouble-Blind MethodDrug Therapy, CombinationFemaleFructoseHumansMaleMiddle AgedObesityPhenterminePolysomnographyAnti-Obesity AgentsAppetite DepressantsDelayed-Action PreparationsFructosePhentermineTopiramateapnea-hypopnea indexobesityObstructive sleep apneaphenterminetopiramate

Identifiers

PMID23115402
PMCPMC3466800
OpenAlexW2073308086

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.