Evidence map›Paper›PMID 30586757›Full record

Trial reportCirculation2019

Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial.

David Fitchett, Silvio E Inzucchi, Christopher P Cannon, Darren K McGuire, Benjamin M Scirica, Odd Erik Johansen, Steven Sambevski, Stefan Kaspers, Egon Pfarr, Jyothis T George and 1 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC 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 is linked to 2 registered trials, which are not on this map. Cited by 182 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
182citing papers in PubMed, 15 pooled it
–field-weighted citation impact
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.

NCT06097585 unknown statusstarted 2023, after this paper: background citation

Effect of Gliflozins on Heart Failure Due to Regurgitant Rheumatic Valve Disease

Ran2023Enrolled150Registered outcomes5Posted comparisons0ConditionsHeart Failure, Rheumatic Heart DiseaseArmsSGLT2 inhibitor
PMID 24491689PMID 27188830PMID 28285457PMID 31535829PMID 32865377PMID 25589482PMID 26343814other papers from this trial
Open the trial in the graph
NCT01131676 phase3completednot on this map

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2015Enrolled7,064ConditionsDiabetes Mellitus, Type 2ArmsBI 10773 low dose, Placebo BI 10773 high dose, BI 10773 high dose, Placebo BI 10773 low dose
3 · Its place in the literature

Who cites it

182 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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122 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

11 authors.

David FitchettSt Michael's Hospital, Division of Cardiology, University of Toronto, Canada (D.F.).
Silvio E InzucchiSection of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).
Christopher P CannonCardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA (C.P.C., B.M.S.).
Darren K McGuireUniversity of Texas Southwestern Medical Center, Dallas (D.K.M.).
Benjamin M SciricaCardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA (C.P.C., B.M.S.).
Odd Erik JohansenBoehringer Ingelheim Norway KS, Asker (O.E.J.).
Steven SambevskiBoehringer Ingelheim International GmbH, Ingelheim, Germany (S.S., S.K., E.P., J.T.G.).
Stefan KaspersBoehringer Ingelheim International GmbH, Ingelheim, Germany (S.S., S.K., E.P., J.T.G.).
Egon PfarrBoehringer Ingelheim International GmbH, Ingelheim, Germany (S.S., S.K., E.P., J.T.G.).
Jyothis T GeorgeBoehringer Ingelheim International GmbH, Ingelheim, Germany (S.S., S.K., E.P., J.T.G.).
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada (B.Z.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, in comparison with placebo, empagliflozin reduced the risks of 3-point major adverse cardiovascular events (3-point MACE), cardiovascular and all-cause death, and hospitalization for heart failure. We investigated whether these effects varied across the spectrum of baseline cardiovascular risk.

methodsCardiovascular death, all-cause mortality, 3-point MACE, and hospitalization for heart failure in the pooled empagliflozin and placebo groups were analyzed in subgroups by prior myocardial infarction and stroke at baseline, and by estimated baseline cardiovascular risk based on the 10-point TIMI (Thrombolysis In Myocardial Infarction) Risk Score for Secondary Prevention.

resultsOf 7020 patients who received the study drug, 65% had a prior myocardial infarction or stroke, and 12%, 40%, 30%, and 18% were at low, intermediate, high, and highest estimated cardiovascular risk according to TIMI Risk Score for Secondary Prevention (≤2, 3, 4, and ≥5 points, respectively). In the placebo group, 3-point MACE occurred during the trial in 7.3%, 9.4%, 12.6%, and 20.6% of patients at low, intermediate, high, and highest estimated baseline risk, respectively. Relative reductions in risk of cardiovascular death, all-cause mortality, 3-point MACE and hospitalization for heart failure with empagliflozin versus placebo were consistent in patients with and without prior myocardial infarction and/or stroke and across subgroups by TIMI Risk Score for Secondary Prevention at baseline ( P>0.05 for randomized group-by-subgroup interactions).

conclusionsDespite all patients having atherosclerotic cardiovascular disease, patients in EMPA-REG OUTCOME demonstrated a broad risk spectrum for cardiovascular events. Reductions in key cardiovascular outcomes and mortality with empagliflozin versus placebo were consistent across the range of cardiovascular risk. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676.

Indexed as

Patient AdmissionAgedAtherosclerosisBenzhydryl CompoundsCause of DeathDiabetes Mellitus, Type 2FemaleGlucosidesHeart FailureHumansMaleMiddle AgedRisk AssessmentRisk FactorsSodium-Glucose Transporter 2 InhibitorsTime FactorsBenzhydryl CompoundsempagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitorscardiovascular diseasescarotid artery diseasesdeath, sudden, cardiacdiabetes mellitus, type 2sodium-glucose transporter 2

Identifiers

PMID30586757
PMCPMC6416009

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LicenceCC BY
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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.