Early changes in estimated glomerular filtration rate post-initiation of empagliflozin in EMPEROR-Reduced.


Journal

European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595

Informations de publication

Date de publication:
10 2022
Historique:
revised: 18 05 2022
received: 06 10 2021
accepted: 09 06 2022
pubmed: 18 6 2022
medline: 29 11 2022
entrez: 17 6 2022
Statut: ppublish

Résumé

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) may induce an early post-initiation decrease of estimated glomerular filtration rate (eGFR), which does not impact the SGLT2i benefits. The occurrence, characteristics, determinants, and clinical significance of an initial eGFR change among patients with heart failure with reduced ejection fraction require further study. In this study we aimed to describe eGFR change from randomization to week 4 (as percent of change relative to randomization) and assess its impact in EMPEROR-Reduced. Landmark analyses (week 4) were performed. eGFR change was available in 3547 patients out of 3730 (95%). The tertiles of post-initiation % eGFR change for empagliflozin were: tertile 1 (T1) ≤-11.4%; T2 ≥-11.4% to ≤-1.0% and T3 ≥0.0%. The placebo group tertiles were: T1 ≤-6.5%; T2 ≥-6.4% to ≤+3.6%; and T3 ≥+3.6%. On average, empagliflozin induced a leftward distributional shift of initial eGFR changes of -2.5 ml/min/1.73 m A mild eGFR decrease may be expected after the initiation of empagliflozin, and it is not associated with untoward heart failure, mortality, or kidney safety events. Clinicians should not be concerned with early eGFR changes post-initiation of empagliflozin.

Identifiants

pubmed: 35711093
doi: 10.1002/ejhf.2578
doi:

Substances chimiques

empagliflozin HDC1R2M35U
Sodium-Glucose Transporter 2 Inhibitors 0

Banques de données

ClinicalTrials.gov
['NCT03057977']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1829-1839

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022 European Society of Cardiology.

Références

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Auteurs

Faiez Zannad (F)

Université de Lorraine, Inserm, Center d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.

João Pedro Ferreira (JP)

Université de Lorraine, Inserm, Center d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.

John Gregson (J)

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

Bettina Johanna Kraus (BJ)

Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.
Würzburg University Clinic, Würzburg, Germany.

Michaela Mattheus (M)

Biostatistics, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.

Sibylle Jenny Hauske (SJ)

Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Vth Department of Medicine, University Medical Center Mannheim, University of Heidelberg, Heidelberg, Germany.

Javed Butler (J)

Baylor Scott and White Research Institute, TX and University of Mississippi, Jackson, MS, USA.

Gerasimos Filippatos (G)

National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Christoph Wanner (C)

Würzburg University Clinic, Würzburg, Germany.

Stefan D Anker (SD)

Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.

Stuart J Pocock (SJ)

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

Milton Packer (M)

Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.
Imperial College, London, UK.

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