Evidence map›Paper›PMID 30882239›Full record

Trial reportCirculation2019

Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction.

Remo H M Furtado, Marc P Bonaca, Itamar Raz, Thomas A Zelniker, Ofri Mosenzon, Avivit Cahn, Julia Kuder, Sabina A Murphy, Deepak L Bhatt, Lawrence A Leiter and 9 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2019. 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 145 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 17 pooled it
31.9field-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.

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
NCT03968224 phase2 / phase3completed

Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III

Ran2018Enrolled160Registered outcomes7Posted comparisons4ConditionsDiabetes Mellitus, Type 2, Obesity, Morbid, PrediabetesArmsDapagliflozin/Metformin, Metformin
PMID 27333994PMID 25015317PMID 30742570PMID 24144654PMID 26203064PMID 24919526PMID 22238392PMID 7623902PMID 11118008PMID 7623903PMID 24463454PMID 11975807other papers from this trial
Open the trial in the graph
NCT06286878 phase2 / phase3recruitingstarted 2021, after this paper: background citation

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Ran2021Enrolled80Registered outcomes4Posted comparisons0ConditionsAcute Coronary Syndrome, Diabetes, Myocardial Infarction, Ventricular DysfunctionArmsdapagliflozin, Placebo
PMID 14502100PMID 28605608PMID 21205121PMID 26026848PMID 27295427PMID 28522450PMID 11602624PMID 30424892PMID 11179406PMID 11595605PMID 16046311PMID 17852797other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 17 syntheses or guidelines pooled it, 327 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

Remo H M FurtadoThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Marc P BonacaCPC Clinical Research and Vascular Research Unity, University of Colorado, Denver (M.P.B.).
Itamar RazDiabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (I.R., O.M., A.C.).
Thomas A ZelnikerThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Ofri MosenzonDiabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (I.R., O.M., A.C.).
Avivit CahnDiabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (I.R., O.M., A.C.).
Julia KuderThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Sabina A MurphyThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Deepak L BhattThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Lawrence A LeiterLi Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Ontario, Canada (L.A.L.).
Darren K McGuireDivision of Cardiology, University of Texas Southwestern Medical Center, Dallas (D.K.M.).
John P H WildingInstitute of Ageing and Chronic Disease, University of Liverpool, UK (J.P.H.W.).
Christian T RuffThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Jose C NicolauInstituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de Sao Paulo, Brazil (R.H.M.F., J.C.N.).
Ingrid A M Gause-NilssonAstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., M.F., A.M.L.).
Martin FredrikssonAstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., M.F., A.M.L.).
Anna Maria LangkildeAstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., M.F., A.M.L.).
Marc S SabatineThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
Stephen D WiviottThrombolysis in Myocardial Infarction (TIMI) Study Group-Brigham and Women's Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).
The University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium glucose transporter-2 inhibitors reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus and a history of atherosclerotic cardiovascular disease. Because of their baseline risk, patients with previous myocardial infarction (MI) may derive even greater benefit from sodium glucose transporter-2 inhibitor therapy.

methodsDECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) randomized 17 160 patients with type 2 diabetes mellitus and either established atherosclerotic cardiovascular disease (n=6974) or multiple risk factors (n=10 186) to dapagliflozin versus placebo. The 2 primary end points were composite of MACE (cardiovascular death, MI, or ischemic stroke) and the composite of cardiovascular death or hospitalization for heart failure. Those with previous MI (n=3584) made up a prespecified subgroup of interest.

resultsIn patients with previous MI (n=3584), dapagliflozin reduced the relative risk of MACE by 16% and the absolute risk by 2.6% (15.2% versus 17.8%; hazard ratio [HR], 0.84; 95% CI, 0.72-0.99; P=0.039), whereas there was no effect in patients without previous MI (7.1% versus 7.1%; HR, 1.00; 95% CI, 0.88-1.13; P=0.97; P for interaction for relative difference=0.11; P for interaction for absolute risk difference=0.048), including in patients with established atherosclerotic cardiovascular disease but no history of MI (12.6% versus 12.8%; HR, 0.98; 95% CI, 0.81-1.19). There seemed to be a greater benefit for MACE within 2 years after the last acute event ( P for interaction trend=0.007). The relative risk reductions in cardiovascular death/hospitalization for heart failure were more similar, but the absolute risk reductions tended to be greater: 1.9% (8.6% versus 10.5%; HR, 0.81; 95% CI, 0.65-1.00; P=0.046) and 0.6% (3.9% versus 4.5%; HR, 0.85; 95% CI, 0.72-1.00; P=0.055) in patients with and without previous MI, respectively ( P interaction for relative difference=0.69; P interaction for absolute risk difference=0.010).

conclusionsPatients with type 2 diabetes mellitus and previous MI are at high risk of MACE and cardiovascular death/hospitalization for heart failure. Dapagliflozin appears to robustly reduce the risk of both composite outcomes in these patients. Future studies should aim to confirm the large clinical benefits with sodium glucose transporter-2 inhibitors we observed in patients with previous MI. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534.

Indexed as

HospitalizationAgedBenzhydryl CompoundsBrain IschemiaCause of DeathDiabetes Mellitus, Type 2Disease ProgressionDouble-Blind MethodFemaleGlucosidesHeart FailureHumansMaleMiddle AgedMyocardial InfarctionRecurrenceBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitorsmyocardial infarctionsodium-glucose transporter 2 inhibitorstype 2 diabetes mellitus

Identifiers

PMID30882239
OpenAlexW2919368874

What Socratic 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 Socratic graph.