Evidence map›Paper›PMID 33611623›Full record

ArticleDiabetologia2021

The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus.

Michelle L O'Donoghue, Eri T Kato, Ofri Mosenzon, Sabina A Murphy, Avivit Cahn, Marisol Herrera, Tsvetalina Tankova, Alena Šmahelová, Piera Merlini, Ingrid Gause-Nilsson and 8 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Diabetologia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01730534. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
4.0field-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.

NCT01730534 phase3completed

Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

Ran2013Enrolled17,190Registered outcomes4Posted comparisons4ConditionsDiabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular EventArmsDapagliflozin 10 mg, Placebo tablet
Open the trial in the graph
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  12. Novel Cardiometabolic Medications in the Cardiovascular-Kidney-Metabolic Syndrome Era.The Journal of clinical endocrinology and metabolism · 2025 · on this map
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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

18 authors at 11 institutions in 9 countries.

Michelle L O'DonoghueTIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA. modonoghue@bwh.harvard.edu.
Eri T KatoDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Ofri MosenzonDiabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Sabina A MurphyTIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Avivit CahnDiabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Marisol HerreraTorre Medica Providencia, Guadalajara, Mexico.
Tsvetalina TankovaDepartment of Endocrinology, Medical University, Sofia, Bulgaria.
Alena ŠmahelováFaculty Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
Piera Merlini2nd Division of Cardiology, Ca' Granda Niguarda Hospital, Milan, Italy.
Ingrid Gause-NilssonBioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anna Maria LangkildeBioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Darren K McGuireDivision of Cardiology, University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, TX, USA.
John P H WildingInstitute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
Larry A LeiterLi Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Deepak L BhattTIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Itamar RazDiabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Marc S SabatineTIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Stephen D WiviottTIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Brigham and Women's Hospital · USAstraZeneca (Sweden) · SEThrombolysis in Myocardial Infarction Study Group · USAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITHospital Médica Sur · MXKyoto University · JPMedical University of Sofia · BGParkland Health & Hospital System · USUniversity Hospital Hradec Králové · CZUniversity of Liverpool · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisWomen remain underrepresented in clinical trials and those with type 2 diabetes mellitus are at high risk for cardiovascular (CV) events. The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin reduces the risk of CV death or heart failure hospitalisations in individuals with type 2 diabetes. Here, we performed a pre-specified analysis to examine whether sex modifies these effects.

methodsThe DECLARE-TIMI 58 trial randomised 17,160 patients with type 2 diabetes with or at risk for atherosclerotic disease to dapagliflozin or placebo (median follow-up 4.2 years). The dual efficacy outcomes were CV death or heart failure hospitalisations, and major adverse cardiovascular events (MACE; CV death, myocardial infarction or ischaemic stroke). The renal-specific composite outcome was a sustained ≥40% drop in eGFR to <60 ml min

resultsAt baseline, women (n = 6422, 37.4%) had higher HbA CONCLUSIONS/

interpretationDapagliflozin offers comparable CV and renal benefits and a comparable safety profile in women and men.

fundingAstraZeneca.

trial registrationclinicaltrials.gov NCT01730534.

Indexed as

AgedBenzhydryl CompoundsDiabetes Mellitus, Type 2FemaleGlucosidesHeart Disease Risk FactorsHumansMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 InhibitorsCardiovascular outcomesClinical trialsSGLT2 inhibitorsWomen

Identifiers

PMID33611623
OpenAlexW3129813952

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.