Evidence map›Paper›PMID 38926835›Full record

ArticleCardiovascular diabetology2024

Empagliflozin's role in reducing ventricular repolarization heterogeneity: insights into cardiovascular mortality decline from the EMPATHY-HEART trial.

Cristiane Lauretti, Graziella L Antonio, Ariana E Fernandes, Fernando G Stocco, Adriana C C Girardi, Richard L Verrier, Bruno Caramelli

Abstract readMulticenter Study
In one paragraph

Article in Cardiovascular diabetology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

7 authors.

Cristiane LaurettiInterdisciplinary Medicine Unit in Cardiology, Heart Institute of the Clinical Hospital of the Medical School of the University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44- Anexo II, Sao Paulo, 05403000, SP, Brazil.
Graziella L AntonioInterdisciplinary Medicine Unit in Cardiology, Heart Institute of the Clinical Hospital of the Medical School of the University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44- Anexo II, Sao Paulo, 05403000, SP, Brazil.
Ariana E FernandesInterdisciplinary Medicine Unit in Cardiology, Heart Institute of the Clinical Hospital of the Medical School of the University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44- Anexo II, Sao Paulo, 05403000, SP, Brazil.
Fernando G StoccoInterdisciplinary Medicine Unit in Cardiology, Heart Institute of the Clinical Hospital of the Medical School of the University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44- Anexo II, Sao Paulo, 05403000, SP, Brazil.
Adriana C C GirardiMedical School Laboratory of Genetics and Molecular Cardiology , Heart Institute of the Clinical Hospital University of Sao Paulo , Sao Paulo, 05403000, Brazil, SP.
Richard L VerrierHarvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, 02215, United States of America.
Bruno CaramelliInterdisciplinary Medicine Unit in Cardiology, Heart Institute of the Clinical Hospital of the Medical School of the University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44- Anexo II, Sao Paulo, 05403000, SP, Brazil. bcaramel@usp.br.

Funding

National Council for Scientific and Technological Development (CNPQ) 309454/2020-4Sao Paulo Research Foundation (FAPESP) 2020/02668-2
6 · The paper itself

Abstract

backgroundThe incidence of myocardial infarction (MI) and sudden cardiac death (SCD) is significantly higher in individuals with Type 2 Diabetes Mellitus (T2DM) than in the general population. Strategies for the prevention of fatal arrhythmias are often insufficient, highlighting the need for additional non-invasive diagnostic tools. The T-wave heterogeneity (TWH) index measures variations in ventricular repolarization and has emerged as a promising predictor for severe ventricular arrhythmias. Although the EMPA-REG trial reported reduced cardiovascular mortality with empagliflozin, the underlying mechanisms remain unclear. This study investigates the potential of empagliflozin in mitigating cardiac electrical instability in patients with T2DM and coronary heart disease (CHD) by examining changes in TWH.

methodsParticipants were adult outpatients with T2DM and CHD who exhibited TWH > 80 µV at baseline. They received a 25 mg daily dose of empagliflozin and were evaluated clinically including electrocardiogram (ECG) measurements at baseline and after 4 weeks. TWH was computed from leads V4, V5, and V6 using a validated technique. The primary study outcome was a significant (p < 0.05) change in TWH following empagliflozin administration.

resultsAn initial review of 6,000 medical records pinpointed 800 patients for TWH evaluation. Of these, 412 exhibited TWH above 80 µV, with 97 completing clinical assessments and 90 meeting the criteria for high cardiovascular risk enrollment. Empagliflozin adherence exceeded 80%, resulting in notable reductions in blood pressure without affecting heart rate. Side effects were generally mild, with 13.3% experiencing Level 1 hypoglycemia, alongside infrequent urinary and genital infections. The treatment consistently reduced mean TWH from 116 to 103 µV (p = 0.01).

conclusionsThe EMPATHY-HEART trial preliminarily suggests that empagliflozin decreases heterogeneity in ventricular repolarization among patients with T2DM and CHD. This reduction in TWH may provide insight into the mechanism behind the decreased cardiovascular mortality observed in previous trials, potentially offering a therapeutic pathway to mitigate the risk of severe arrhythmias in this population.

trial registrationNCT: 04117763.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesSodium-Glucose Transporter 2 InhibitorsAction PotentialsAgedArrhythmias, CardiacCoronary DiseaseElectrocardiographyFemaleHeart RateHumansMaleMiddle AgedRisk FactorsTime FactorsBenzhydryl CompoundsempagliflozinGlucosidesSodium-Glucose Transporter 2 InhibitorsArrhythmia preventionCardiovascular mortalityCoronary heart diseaseElectrical instabilityEmpagliflozinEMPA-REG TrialNon-invasive diagnostic toolsT-wave heterogeneityType 2 diabetes MellitusVentricular Arrhythmias

Identifiers

PMID38926835
PMCPMC11210164

What Socratic holds

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Registered trials

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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.