Evidence map›Paper›PMID 33026243›Full record

Trial reportCirculation2020

Efficacy of Ertugliflozin on Heart Failure-Related Events in Patients With Type 2 Diabetes Mellitus and Established Atherosclerotic Cardiovascular Disease: Results of the VERTIS CV Trial.

Francesco Cosentino, Christopher P Cannon, David Z I Cherney, Urszula Masiukiewicz, Richard Pratley, Sam Dagogo-Jack, Robert Frederich, Bernard Charbonnel, James Mancuso, Weichung J Shih and 5 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2020. 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 116 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 27 pooled it
25.1field-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.

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

116 citing papers in PubMed, 27 syntheses or guidelines pooled it, 240 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 4 countries.

Francesco CosentinoUnit of Cardiology, Karolinska Institute and Karolinska University Hospital Solna, Stockholm, Sweden (F.C.).
Christopher P CannonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (C.P.C.).
David Z I CherneyUniversity of Toronto, Ontario, Canada (D.Z.I.C.).
Urszula MasiukiewiczPfizer Inc, Groton, CT (U.M., J.M.).
Richard PratleyAdventHealth Translational Research Institute, Orlando, FL (R.P.).
Sam Dagogo-JackUniversity of Tennessee Health Science Center, Memphis (S.D.-J.).
Robert FrederichPfizer Inc, Collegeville, PA (R.F.).
Bernard CharbonnelUniversity of Nantes, France (B.C.).
James MancusoPfizer Inc, Groton, CT (U.M., J.M.).
Weichung J ShihRutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.).
Steven G TerraPfizer Inc, Andover, MA (S.G.T).
Nilo B CaterPfizer Inc, New York (N.B.C.).
Ira GantzMerck & Co Inc, Kenilworth, NJ (I.G.).
Darren K McGuireUniversity of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas (D.K.M.).
VERTIS CV Investigators
Pfizer (United States) · USBrigham and Women's Hospital · USKarolinska University Hospital · SEMerck & Co., Inc., Rahway, NJ, USA (United States) · USNantes Université · FRParkland Health & Hospital System · USRutgers, The State University of New Jersey · USTranslational Research Institute for Metabolism and Diabetes · USUniversity of Tennessee Health Science Center · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with type 2 diabetes mellitus, sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure (HHF). We assessed the effect of ertugliflozin on HHF and related outcomes.

methodsVERTIS CV (Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial), a double-blind, placebo-controlled trial, randomly assigned patients with type 2 diabetes mellitus and atherosclerotic cardiovascular (CV) disease to once-daily ertugliflozin 5 mg, 15 mg, or placebo. Prespecified secondary analyses compared ertugliflozin (pooled doses) versus placebo on time to first event of HHF and composite of HHF/CV death, overall and stratified by prespecified characteristics. Cox proportional hazards modeling was used with the Fine and Gray method to account for competing mortality risk, and Andersen-Gill modeling to analyze total (first+recurrent) HHF and total HHF/CV death events.

resultsA total of 8246 patients were randomly assigned to ertugliflozin (n=5499) or placebo (n=2747); n=1958 (23.7%) had a history of heart failure (HF) and n=5006 (60.7%) had pretrial ejection fraction (EF) available, including n=959 with EF ≤45%. Ertugliflozin did not significantly reduce first HHF/CV death (hazard ratio [HR], 0.88 [95% CI, 0.75-1.03]). Overall, ertugliflozin reduced risk for first HHF (HR, 0.70 [95% CI, 0.54-0.90];

conclusionsIn patients with type 2 diabetes mellitus, ertugliflozin reduced the risk for first and total HHF and total HHF/CV death, adding further support for the use of sodium-glucose cotransporter 2 inhibitors in primary and secondary prevention of HHF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01986881.

Indexed as

AgedAtherosclerosisBridged Bicyclo Compounds, HeterocyclicCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleHeart FailureHumansMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsBridged Bicyclo Compounds, HeterocyclicertugliflozinSodium-Glucose Transporter 2 Inhibitorscardiovascular diseasesdiabetes mellitus, type 2heart failuresodium-glucose cotransporter 2 inhibitors

Identifiers

PMID33026243
PMCPMC7717477
OpenAlexW3092434593

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.