Cargando…
The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial
The sodium–glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failu...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group US
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8938265/ https://www.ncbi.nlm.nih.gov/pubmed/35228754 http://dx.doi.org/10.1038/s41591-021-01659-1 |
_version_ | 1784672516947574784 |
---|---|
author | Voors, Adriaan A. Angermann, Christiane E. Teerlink, John R. Collins, Sean P. Kosiborod, Mikhail Biegus, Jan Ferreira, João Pedro Nassif, Michael E. Psotka, Mitchell A. Tromp, Jasper Borleffs, C. Jan Willem Ma, Changsheng Comin-Colet, Joseph Fu, Michael Janssens, Stefan P. Kiss, Robert G. Mentz, Robert J. Sakata, Yasushi Schirmer, Henrik Schou, Morten Schulze, P. Christian Spinarova, Lenka Volterrani, Maurizio Wranicz, Jerzy K. Zeymer, Uwe Zieroth, Shelley Brueckmann, Martina Blatchford, Jonathan P. Salsali, Afshin Ponikowski, Piotr |
author_facet | Voors, Adriaan A. Angermann, Christiane E. Teerlink, John R. Collins, Sean P. Kosiborod, Mikhail Biegus, Jan Ferreira, João Pedro Nassif, Michael E. Psotka, Mitchell A. Tromp, Jasper Borleffs, C. Jan Willem Ma, Changsheng Comin-Colet, Joseph Fu, Michael Janssens, Stefan P. Kiss, Robert G. Mentz, Robert J. Sakata, Yasushi Schirmer, Henrik Schou, Morten Schulze, P. Christian Spinarova, Lenka Volterrani, Maurizio Wranicz, Jerzy K. Zeymer, Uwe Zieroth, Shelley Brueckmann, Martina Blatchford, Jonathan P. Salsali, Afshin Ponikowski, Piotr |
author_sort | Voors, Adriaan A. |
collection | PubMed |
description | The sodium–glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09–1.68; P = 0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment. |
format | Online Article Text |
id | pubmed-8938265 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group US |
record_format | MEDLINE/PubMed |
spelling | pubmed-89382652022-04-07 The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial Voors, Adriaan A. Angermann, Christiane E. Teerlink, John R. Collins, Sean P. Kosiborod, Mikhail Biegus, Jan Ferreira, João Pedro Nassif, Michael E. Psotka, Mitchell A. Tromp, Jasper Borleffs, C. Jan Willem Ma, Changsheng Comin-Colet, Joseph Fu, Michael Janssens, Stefan P. Kiss, Robert G. Mentz, Robert J. Sakata, Yasushi Schirmer, Henrik Schou, Morten Schulze, P. Christian Spinarova, Lenka Volterrani, Maurizio Wranicz, Jerzy K. Zeymer, Uwe Zieroth, Shelley Brueckmann, Martina Blatchford, Jonathan P. Salsali, Afshin Ponikowski, Piotr Nat Med Article The sodium–glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09–1.68; P = 0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment. Nature Publishing Group US 2022-02-28 2022 /pmc/articles/PMC8938265/ /pubmed/35228754 http://dx.doi.org/10.1038/s41591-021-01659-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Voors, Adriaan A. Angermann, Christiane E. Teerlink, John R. Collins, Sean P. Kosiborod, Mikhail Biegus, Jan Ferreira, João Pedro Nassif, Michael E. Psotka, Mitchell A. Tromp, Jasper Borleffs, C. Jan Willem Ma, Changsheng Comin-Colet, Joseph Fu, Michael Janssens, Stefan P. Kiss, Robert G. Mentz, Robert J. Sakata, Yasushi Schirmer, Henrik Schou, Morten Schulze, P. Christian Spinarova, Lenka Volterrani, Maurizio Wranicz, Jerzy K. Zeymer, Uwe Zieroth, Shelley Brueckmann, Martina Blatchford, Jonathan P. Salsali, Afshin Ponikowski, Piotr The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title | The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title_full | The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title_fullStr | The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title_full_unstemmed | The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title_short | The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
title_sort | sglt2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8938265/ https://www.ncbi.nlm.nih.gov/pubmed/35228754 http://dx.doi.org/10.1038/s41591-021-01659-1 |
work_keys_str_mv | AT voorsadriaana thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT angermannchristianee thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT teerlinkjohnr thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT collinsseanp thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT kosiborodmikhail thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT biegusjan thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT ferreirajoaopedro thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT nassifmichaele thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT psotkamitchella thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT trompjasper thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT borleffscjanwillem thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT machangsheng thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT comincoletjoseph thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT fumichael thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT janssensstefanp thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT kissrobertg thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT mentzrobertj thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT sakatayasushi thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schirmerhenrik thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schoumorten thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schulzepchristian thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT spinarovalenka thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT volterranimaurizio thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT wraniczjerzyk thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT zeymeruwe thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT zierothshelley thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT brueckmannmartina thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT blatchfordjonathanp thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT salsaliafshin thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT ponikowskipiotr thesglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT voorsadriaana sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT angermannchristianee sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT teerlinkjohnr sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT collinsseanp sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT kosiborodmikhail sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT biegusjan sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT ferreirajoaopedro sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT nassifmichaele sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT psotkamitchella sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT trompjasper sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT borleffscjanwillem sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT machangsheng sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT comincoletjoseph sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT fumichael sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT janssensstefanp sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT kissrobertg sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT mentzrobertj sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT sakatayasushi sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schirmerhenrik sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schoumorten sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT schulzepchristian sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT spinarovalenka sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT volterranimaurizio sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT wraniczjerzyk sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT zeymeruwe sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT zierothshelley sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT brueckmannmartina sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT blatchfordjonathanp sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT salsaliafshin sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial AT ponikowskipiotr sglt2inhibitorempagliflozininpatientshospitalizedforacuteheartfailureamultinationalrandomizedtrial |