Evidence map›Paper›PMID 33665685›Full record

Trial reportDiabetologia2021

Effects of ertugliflozin on kidney composite outcomes, renal function and albuminuria in patients with type 2 diabetes mellitus: an analysis from the randomised VERTIS CV trial.

David Z I Cherney, Bernard Charbonnel, Francesco Cosentino, Samuel Dagogo-Jack, Darren K McGuire, Richard Pratley, Weichung J Shih, Robert Frederich, Mario Maldonado, Annpey Pong and 2 more

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

Trial report in Diabetologia, 2021. 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 77 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 18 pooled it
20.7field-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.

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

77 citing papers in PubMed, 18 syntheses or guidelines pooled it, 158 citations in OpenAlex.

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17 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

12 authors at 7 institutions in 5 countries.

David Z I CherneyUniversity of Toronto, Toronto, ON, Canada. david.cherney@uhn.ca.ORCID https://orcid.org/0000-0003-4164-0429
Bernard CharbonnelUniversity of Nantes, Nantes, France.
Francesco CosentinoUnit of Cardiology, Karolinska Institute & Karolinska University Hospital, Stockholm, Sweden.
Samuel Dagogo-JackUniversity of Tennessee Health Science Center, Memphis, TN, USA.
Darren K McGuireUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Richard PratleyAdventHealth Translational Research Institute, Orlando, FL, USA.
Weichung J ShihRutgers School of Public Health, New Brunswick, NJ, USA.
Robert FrederichPfizer Inc., Collegeville, PA, USA.
Mario MaldonadoMSD Limited, London, UK.
Annpey PongMerck & Co., Inc., Kenilworth, NJ, USA.
Christopher P CannonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
VERTIS CV Investigators
Brigham and Women's Hospital · USKarolinska University Hospital · SEParkland Health & Hospital System · USRutgers, The State University of New Jersey · USUniversity of Toronto · CAMerck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisIn previous work, we reported the HR for the risk (95% CI) of the secondary kidney composite endpoint (time to first event of doubling of serum creatinine from baseline, renal dialysis/transplant or renal death) with ertugliflozin compared with placebo as 0.81 (0.63, 1.04). The effect of ertugliflozin on exploratory kidney-related outcomes was evaluated using data from the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes (VERTIS CV) trial (NCT01986881).

methodsIndividuals with type 2 diabetes mellitus and established atherosclerotic CVD were randomised to receive ertugliflozin 5 mg or 15 mg (observations from both doses were pooled), or matching placebo, added on to existing treatment. The kidney composite outcome in VERTIS CV (reported previously) was time to first event of doubling of serum creatinine from baseline, renal dialysis/transplant or renal death. The pre-specified exploratory composite outcome replaced doubling of serum creatinine with sustained 40% decrease from baseline in eGFR. In addition, the impact of ertugliflozin on urinary albumin/creatinine ratio (UACR) and eGFR over time was assessed.

resultsA total of 8246 individuals were randomised and followed for a mean of 3.5 years. The exploratory kidney composite outcome of sustained 40% reduction from baseline in eGFR, chronic kidney dialysis/transplant or renal death occurred at a lower event rate (events per 1000 person-years) in the ertugliflozin group than with the placebo group (6.0 vs 9.0); the HR (95% CI) was 0.66 (0.50, 0.88). At 60 months, in the ertugliflozin group, placebo-corrected changes from baseline (95% CIs) in UACR and eGFR were -16.2% (-23.9, -7.6) and 2.6 ml min CONCLUSIONS/

interpretationAmong individuals with type 2 diabetes and atherosclerotic CVD, ertugliflozin reduced the risk for the pre-specified exploratory composite renal endpoint and was associated with preservation of eGFR and reduced UACR.

trial registrationClinicalTrials.gov NCT01986881.

Indexed as

AgedAlbuminuriaBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Diabetic NephropathiesFemaleHumansKidneyMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeBridged Bicyclo Compounds, HeterocyclicertugliflozinSodium-Glucose Transporter 2 InhibitorsCardiovascular diseaseDiabetic nephropathiesErtugliflozinType 2 diabetes mellitus

Identifiers

PMID33665685
PMCPMC8099851
OpenAlexW3135510359

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.