Evidence map›Paper›PMID 35596030›Full record

Trial reportSleep & breathing = Schlaf & Atmung2023

Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial.

Brian S Wojeck, Silvio E Inzucchi, Ian J Neeland, James P Mancuso, Robert Frederich, Urszula Masiukiewicz, Nilo B Cater, Darren K McGuire, Christopher P Cannon, Henry Klar Yaggi

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

Trial report in Sleep & breathing = Schlaf & Atmung, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986881 (Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 5% 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.

NCT01986881 phase3completednot on this map

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2019Enrolled8,246ConditionsType 2 Diabetes MellitusArmsErtugliflozin, Placebo, Glycemic Rescue
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Evaluating the potential of metabolic drugs in obstructive sleep apnea and obesity: a narrative review.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Review
  8. Pharmacological management of sleep apnea and obesity, a new frontier.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Article
  9. A Structured Narrative Review of the OSA-T2DM Axis.Journal of clinical medicine · 2025
    Review
  10. Review
  11. Tofogliflozin reduces sleep apnea severity in patients with type 2 diabetes mellitus and heart failure: a prospective study.Hypertension research : official journal of the Japanese Society of Hypertension · 2025
    Article
  12. Review
  13. Obstructive sleep apnea -related hypertension: a review of the literature and clinical management strategy.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  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

10 authors at 6 institutions in 1 country.

Brian S WojeckSection of Endocrinology, Yale School of Medicine, 33 Cedar Street, P.O. Box 208020, New Haven, CT, 06520, USA. Brian.Wojeck@yale.edu.
Silvio E InzucchiSection of Endocrinology, Yale School of Medicine, 33 Cedar Street, P.O. Box 208020, New Haven, CT, 06520, USA.
Ian J NeelandHarrington Heart and Vascular Institute University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.
James P MancusoPfizer Inc, Groton, CT, USA.
Robert FrederichPfizer Inc, Collegeville, PA, USA.
Urszula MasiukiewiczSection of Endocrinology, Yale School of Medicine, 33 Cedar Street, P.O. Box 208020, New Haven, CT, 06520, USA.
Nilo B CaterPfizer Inc, New York, NY, USA.
Darren K McGuireUniversity of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas, TX, USA.
Christopher P CannonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Henry Klar YaggiSection of Pulmonary, Critical Care and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.
Pfizer (United States) · USYale University · USBrigham and Women's Hospital · USCase Western Reserve University · USThe University of Texas Southwestern Medical Center · USVA Connecticut Healthcare System · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI GERALD I SHULMAN · 1993 to 2026
$44.0M
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

purposeThe sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin may reduce the incidence of obstructive sleep apnea (OSA) in patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. This analysis of VERTIS CV, the CV outcome trial for the SGLT2i ertugliflozin conducted in a similar group of patients, explored the effects of ertugliflozin on reported incident OSA.

methodsIn VERTIS CV, patients ≥ 40 years with T2D and atherosclerotic CV disease (ASCVD) were randomized to ertugliflozin 5 or 15 mg or placebo. The primary endpoint was the composite of major adverse CV events. This exploratory analysis evaluated the impact of ertugliflozin (5 and 15 mg pooled) on incident OSA. Patients with prevalent OSA were excluded. Incident OSA events were based on investigator-reported events using the MedDRA SMQ term "sleep apnea syndrome." A multivariable Cox proportional hazards regression model was constructed to assess the association between ertugliflozin and incident OSA.

resultsOf 8246 patients enrolled, 7697 (93.3%) were without baseline OSA (placebo, n = 2561; ertugliflozin, n = 5136; mean age 64.4 years; BMI 31.7 kg/m

conclusionsIn VERTIS CV, ertugliflozin reduced by nearly half the incidence of OSA in patients with T2D and ASCVD. These data contribute to the literature that SGLT2is may have a significant beneficial impact on OSA.

trial registrationCLINICALTRIALS: gov identifier: NCT01986881.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Sleep Apnea, ObstructiveSodium-Glucose Transporter 2 InhibitorsBridged Bicyclo Compounds, HeterocyclicFemaleHumansMaleMiddle AgedBridged Bicyclo Compounds, HeterocyclicertugliflozinSodium-Glucose Transporter 2 InhibitorsOSASGLT2Sleep apneaSleep disordered breathingSodium glucose transporter type 2 inhibitor

Identifiers

PMID35596030
PMCPMC10212814
OpenAlexW4280616327

What OpenQuestion holds

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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.