Empagliflozin in heart failure with a preserved ejection fraction

Stefan D. Anker; Javed Butler; Gerasimos Filippatos; Michael Böhm; Hans‑Peter Brunner-La Rocca; Dong‑Ju Choi; Vijay Chopra; Eduardo Chuquiure‑Valenzuela; Nadia Giannetti; Juan Esteban Gomez‑Mesa; Stefan Janssens; James Louis Januzzi; Jose R. Gonzalez-Juanatey; Bela Merkely; Stephen J. Nicholls; Sergio V. Perrone; Ileana L. Piña; Piotr Ponikowski; Michele Senni; David Sim; Jindrich Spinar; Iain Squire; Stefano Taddei; Hiroyuki Tsutsui; Subodh Verma; Dragos Vinereanu; Jian Zhang; Peter Carson; Carolyn Su Ping Lam; Nikolaus Marx; Cordula Zeller; Naveed Sattar; Waheed Jamal; Sven Schnaidt; Janet M. Schnee; Martina Brueckmann; Faiez Zannad; Milton Packer; Mike Palmer; Klaus G. Parhofer; Terje R. Pedersen; Marvin A. Konstam; Kennedy R. Lees; Wolfram Doehner; Alan Miller; Markus Haas; Steen Pehrson; Michel Komajda; Inder Anand; John Teerlink; Alejandro Rabinstein; Thorsten Steiner; Hooman Kamel; Georgios Tsivgoulis; James Lewis; James Freston; Neil Kaplowitz; Johannes Mann; John Petrie; Edmar Bocchi; Zhang Jian; Juan Esteban Gomez Mesa; Michael Boehm; Dong-Ju Choi; Eduardo Chuquiure; Hans Pieter Brunner La Rocca; Ileana Pina; Richard Bernstein; Alfred Cheung; Jennifer Green; Sanjay Kaul; Carolyn Lam Su Ping; Gregory Lip; Peter McCullough; Cyrus Mehta; Julio Rosenstock; Benjamin Scirica; Sanjiv Shah; Christoph Wanner; D. Aizenberg; L. Cartasegna; H. Colombo; M.J. Fernandez Moutin; M. Koretzky; J. Archibaldo Glenny; C.A. Alvarez Iorio; D.J. Anauch; R. Henquin; V.E. Cavenago; R.C. Campos; A. Facta; A. Fernandez; R.A. Ahuad Guerrero; L. Lobo Márquez; R.A. Leon De La Fuente; M.V. Mansilla; M.A. Hominal; E. Hasbani; M. Najenson; H.A. Luquez; L.A. Guzman; H.A. Sessa; O.A. Salomone; E. Perna; D. Piskorz; M. Sicer; D. Perez De Arenaza; C.J. Zaidman; S. Nani; J. Resk; R.A. Villarreal; C.R. Majul; F. Colombo Berra; T. Smith Casabella; S.A. Sassone; G. Carnero; A. Caccavo; M.A. Berli; N. Budassi; J. Bono; Andrés Alvarisqueta; D. Colquhoun; J. Amerena; J. Beltrame; A. Sverdlov; G. Vaddadi; A. Hamilton; M. Stokes; A. Dhawan; G. Oldfield; L. Howes; R. Lehman; C. De Pasquale; C. Judkins; G. Szto; O. van Den Brink; A. Leone; J. Verwerft; P. Troisfontaines; T. Sarens; F. Chenot; J. De Sutter; E. De Vuyst; C. Godefroid; M. Dupont; O. Pereira Dutra; L.H.S. Canani; M. Da Consolação Vieira Moreira; W.K.S.B. De Souza; L.M. Backes; L.N. Maia; B. De Souza Paolino; E.R. Manenti; W.F. Saporito; F. Villaça Guimarães Filho; R. Lariucci; L.A. Saliba; T. Franco Hirakawa; F.C. Neuenschwander; C.A. de Freitas Zerbini; Y. Gonçalves Mello; J. Ascenção De Souza; L. da Silva Neto; E.A. Bocchi; J. Da Silveira; M.E. Hernandes; H.C. Finimundi; E.F. Vasconcellos; C.R. Sampaio; F.J. Neves Mancuso; M.R. Bacci; M.H. Vidotti; F. Rossi Dos Santos; M.V. Simões; F.L.T. Gomes; C.V. Nascimento; J.-B. de Moura Xavier Moraes; D.B. Precoma; J.A. Ribas Fortes; P.E. Leães; D. Campos de Albuquerque; J.F.K. Saraiva; S. Rassi; F.A. Alves da Costa; G. Reis; S. Zieroth; R. Chehayeb; F. St-Maurice; R. Bourgeois; C. Constance; K. Anderson; S. Verma; M.H. Leblanc; N. Racine; S.A. Virani; D. Yung; E.A. Swiggum; L. Pliamm; B. Tyrrell; T. Huynh; J.-P. Lavoie; M.L. Heffernan; S. Vizel; M.C. Hartleib; A. Costa-Vitali; L.L. Hill; Y. Khaykin; J.A. Ricci; A. Zhai; A.S. Pandey; L. Yao; R. McKelvie; M. Babapulle; G. Curnew; M. Gupta; J. Vyselaar; J.C. Berlingieri; E.M. Lonn; D. Dion; Y. Zheng; Z. Fan; X. Han; H. Xu; Z. Zheng; Y. Zhang; A. Shen; J. Yu; S. Guo; J. Ye; Y. Yao; P. Liu; J. Yan; X. Xu; J. Ma; Y. Li; S. Li; S. Lu; X. Kong; G. Yang; Z. Yao; Y. Pan; X. Guo; Z. Sun; Y. Dong; D. Peng; Z. Yuan; J. Lin; F.A. Trujillo Dada; L.E. Echeverria; M.J.F. Lievano Triana; A.A. Rizcala Muvdi; J.E. Vanegas Eljach; F. Manzur Jattin; J.A. Coronel Arroyo; N. Florez; E. Hernandez Triana; A. Sotomayor Herazo; N.E. Beltran Lopez; C. Arana Londoño; J. Echeverri; H. Burianova; R. Cifkova; V. Durdil; J. Vesely; J. Vaclavik; T. Fiala; P. Vodnansky; V. Cech; Z. Monhart; J. Kettner; R. Miklik; T. Brabec; J. Pisova; K. Zeman; E.C. Zidkova; L. Busak; A. Linhart; M. Radvan; Z. Vomacka; R. Prosecky; J. Hubac; D. Foldyna; O. Hlinomaz; P. Vymetal; O. Ludka; K. Peterka; M. Smid; J. Spac; R. Ferkl; V. Machova; N. Schulze-Waltrup; H. Bourhaial; H.-G. Olbrich; S. Genth-Zotz; E. Kemala; B. Lemke; S. Schellong; W. Rieker; M. Faghih; S. von Haehling; H. Ince; N. Wistorf; T. Dorsel; J. Bauersachs; M. Prull; H. Darius; A. Wilke; J. Sauter; U. Rauch-Kroehnert; A. Al-Zoebi; M. Lutz; N. Frey; C.P. Schulze; W. König; L. Maier; F. Menzel; H. Ebert; H.E. Sarnighausen; H.D. Düngen; P. Salbach; J. Sänger; A.L. Birkenfeld; M. Jeserich; M. Licka; C. Stellbrink; B. Winkelmann; N. Menck; Z. Zilahi; F. Lakatos; J. Tomcsanyi; I. Szakal; L. Nagy; A. Nagy; E. Szolnoki; P. Andrassy; T. Sydo; A. Vorobcsuk; T. Barany; L. Koenyves; G. Simon; A. Matoltsy; E. Noori; S. Zolyomi; I. Horvath; R.G. Kiss; G. Paragh; S. Mittal; V. Rastogi; B. Shah; A. Mullasari; J.S. Krishnamoorthy; V. Mehta; A. Boro; A. Oomman; U. Kaul; S.V. Komarlu; D. Kahali; A. Bhagwat; V.M. Vijan; N.K. Ghaisas; A. Mehta; Y. Kothari; M. Scherillo; M. Vicenzi; B. Reimers; C. Panico; G. Ambrosio; S. Genovese; A. Salvioni; A. Fucili; F. Fedele; D; Douglas L. Kosmicki

doi:10.1056/NEJMoa2107038

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$Empagliflozin in heart failure with a preserved ejection fraction$

Journal article

Peer reviewed

Empagliflozin in heart failure with a preserved ejection fraction

Stefan D. Anker, Javed Butler, Gerasimos Filippatos, Michael Böhm, Hans‑Peter Brunner-La Rocca, Dong‑Ju Choi, Vijay Chopra, Eduardo Chuquiure‑Valenzuela, Nadia Giannetti, Juan Esteban Gomez‑Mesa, …

New England Journal of Medicine, Vol.385(16)

2021

DOI: https://doi.org/10.1056/NEJMoa2107038

Abstract

empagliflozin

placebo

aged

Article

cardiovascular mortality

clinical outcome

confidence interval

controlled study

double blind procedure

drug effect

drug withdrawal

female

genital tract infection

hazard ratio

heart ejection fraction

heart failure

heart failure with preserved ejection fraction

hospitalization

human

hypotension

major clinical study

male

randomized controlled trial

urinary tract infection

BACKGROUND Sodium–glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. METHODS In this double-blind trial, we randomly assigned 5988 patients with class II–IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. RESULTS Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. CONCLUSIONS Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. © 2021 American Society of Civil Engineers.

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Title: Empagliflozin in heart failure with a preserved ejection fraction
Creators: Stefan D. Anker - Charité - Universitätsmedizin Berlin
Javed Butler - Inserm
Gerasimos Filippatos - RWTH Aachen University
Michael Böhm - Universitätsklinikum des Saarlandes
Hans‑Peter Brunner-La Rocca
Dong‑Ju Choi
Vijay Chopra - Inserm
Eduardo Chuquiure‑Valenzuela
Nadia Giannetti - Universitätsklinikum des Saarlandes
Juan Esteban Gomez‑Mesa
Stefan Janssens - University Medical Center
James Louis Januzzi - Heidelberg University
Jose R. Gonzalez-Juanatey - Heidelberg University
Bela Merkely - Inserm
Stephen J. Nicholls - Boehringer Ingelheim (South Korea)
Sergio V. Perrone - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Ileana L. Piña - RWTH Aachen University
Piotr Ponikowski - RWTH Aachen University
Michele Senni - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
David Sim - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Jindrich Spinar - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Iain Squire - Heidelberg University
Stefano Taddei - Universitätsklinikum des Saarlandes
Hiroyuki Tsutsui - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Subodh Verma - Boehringer Ingelheim (South Korea)
Dragos Vinereanu - Heidelberg University
Jian Zhang - University Medical Center
Peter Carson - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Carolyn Su Ping Lam - University Hospital Heidelberg
Nikolaus Marx - Inserm
Cordula Zeller - University Medical Center
Naveed Sattar - University Medical Center
Waheed Jamal - University Hospital Heidelberg
Sven Schnaidt - Universitätsklinikum des Saarlandes
Janet M. Schnee - Berlin Institute of Health at Charité - Universitätsmedizin Berlin
Martina Brueckmann - RWTH Aachen University
Faiez Zannad - Heidelberg University
Milton Packer - RWTH Aachen University
Mike Palmer
Klaus G. Parhofer
Terje R. Pedersen
Marvin A. Konstam
Kennedy R. Lees
Wolfram Doehner
Alan Miller
Markus Haas
Steen Pehrson
Michel Komajda
Inder Anand
John Teerlink
Alejandro Rabinstein
Thorsten Steiner
Hooman Kamel
Georgios Tsivgoulis
James Lewis
James Freston
Neil Kaplowitz
Johannes Mann
John Petrie
Edmar Bocchi
Nadia Giannetti - Universitätsklinikum des Saarlandes
Zhang Jian
Juan Esteban Gomez Mesa
Michael Boehm
Stefano Taddei - Universitätsklinikum des Saarlandes
Dong-Ju Choi
Eduardo Chuquiure
Hans Pieter Brunner La Rocca
Ileana Pina - RWTH Aachen University
Richard Bernstein
Alfred Cheung
Jennifer Green
Sanjay Kaul
Carolyn Lam Su Ping
Gregory Lip
Peter McCullough
Cyrus Mehta
Julio Rosenstock
Benjamin Scirica
Sanjiv Shah
Christoph Wanner
D. Aizenberg
L. Cartasegna
H. Colombo
M.J. Fernandez Moutin
M. Koretzky
J. Archibaldo Glenny
C.A. Alvarez Iorio
D.J. Anauch
R. Henquin
V.E. Cavenago
R.C. Campos
A. Facta
A. Fernandez
R.A. Ahuad Guerrero
L. Lobo Márquez
R.A. Leon De La Fuente
M.V. Mansilla
M.A. Hominal
E. Hasbani
M. Najenson
H.A. Luquez
L.A. Guzman
H.A. Sessa
O.A. Salomone
E. Perna
D. Piskorz
M. Sicer
D. Perez De Arenaza
C.J. Zaidman
S. Nani
J. Resk
R.A. Villarreal
C.R. Majul
F. Colombo Berra
T. Smith Casabella
S.A. Sassone
G. Carnero
A. Caccavo
M.A. Berli
N. Budassi
J. Bono
Andrés Alvarisqueta
D. Colquhoun
J. Amerena
J. Beltrame
A. Sverdlov
G. Vaddadi
A. Hamilton
M. Stokes
A. Dhawan
G. Oldfield
L. Howes
R. Lehman
C. De Pasquale
C. Judkins
G. Szto
O. van Den Brink
A. Leone
J. Verwerft
P. Troisfontaines
T. Sarens
F. Chenot
J. De Sutter
E. De Vuyst
C. Godefroid
M. Dupont
O. Pereira Dutra
L.H.S. Canani
M. Da Consolação Vieira Moreira
W.K.S.B. De Souza
L.M. Backes
L.N. Maia
B. De Souza Paolino
E.R. Manenti
W.F. Saporito
F. Villaça Guimarães Filho
R. Lariucci
L.A. Saliba
T. Franco Hirakawa
F.C. Neuenschwander
C.A. de Freitas Zerbini
Y. Gonçalves Mello
J. Ascenção De Souza
L. da Silva Neto
E.A. Bocchi - Heidelberg University
J. Da Silveira
M.E. Hernandes
H.C. Finimundi
E.F. Vasconcellos
C.R. Sampaio
F.J. Neves Mancuso
M.R. Bacci
M.H. Vidotti
F. Rossi Dos Santos
M.V. Simões
F.L.T. Gomes
C.V. Nascimento
J.-B. de Moura Xavier Moraes
D.B. Precoma
J.A. Ribas Fortes
P.E. Leães
D. Campos de Albuquerque
J.F.K. Saraiva
S. Rassi
F.A. Alves da Costa
G. Reis
S. Zieroth
R. Chehayeb
F. St-Maurice
R. Bourgeois
C. Constance
K. Anderson
S. Verma - Boehringer Ingelheim (South Korea)
M.H. Leblanc
N. Racine
S.A. Virani
D. Yung
E.A. Swiggum
L. Pliamm
B. Tyrrell
T. Huynh
J.-P. Lavoie
M.L. Heffernan
S. Vizel
M.C. Hartleib
A. Costa-Vitali
L.L. Hill
Y. Khaykin
J.A. Ricci
A. Zhai
A.S. Pandey
L. Yao
R. McKelvie
M. Babapulle
G. Curnew
M. Gupta
J. Vyselaar
J.C. Berlingieri
E.M. Lonn
D. Dion
Y. Zheng
Z. Fan
X. Han
H. Xu
Z. Zheng
Y. Zhang
A. Shen
J. Yu
S. Guo
J. Ye
Y. Yao
P. Liu
J. Yan
X. Xu
J. Ma
Y. Li
S. Li
S. Lu
X. Kong
G. Yang
Z. Yao
Y. Zhang
Y. Pan
X. Guo
Z. Sun
Y. Dong
D. Peng
Z. Yuan
J. Lin
F.A. Trujillo Dada
L.E. Echeverria
M.J.F. Lievano Triana
A.A. Rizcala Muvdi
J.E. Vanegas Eljach
F. Manzur Jattin
J.A. Coronel Arroyo
N. Florez
E. Hernandez Triana
A. Sotomayor Herazo
N.E. Beltran Lopez
C. Arana Londoño
J. Echeverri
H. Burianova
R. Cifkova
V. Durdil
J. Vesely
J. Vaclavik
T. Fiala
P. Vodnansky
V. Cech
Z. Monhart
J. Kettner
R. Miklik
T. Brabec
J. Pisova
K. Zeman
E.C. Zidkova
L. Busak
A. Linhart
M. Radvan
Z. Vomacka
R. Prosecky
J. Hubac
D. Foldyna
O. Hlinomaz
P. Vymetal
O. Ludka
K. Peterka
M. Smid
J. Spac
R. Ferkl
V. Machova
N. Schulze-Waltrup
H. Bourhaial
H.-G. Olbrich
S. Genth-Zotz
E. Kemala
B. Lemke
S. Schellong
W. Rieker
M. Faghih
S. von Haehling
H. Ince
N. Wistorf
T. Dorsel
J. Bauersachs
M. Prull
H. Darius
A. Wilke
J. Sauter
U. Rauch-Kroehnert
A. Al-Zoebi
M. Lutz
N. Frey
C.P. Schulze
W. König
L. Maier
F. Menzel
H. Ebert
H.E. Sarnighausen
H.D. Düngen
P. Salbach
J. Sänger
A.L. Birkenfeld
M. Jeserich
M. Licka
C. Stellbrink
B. Winkelmann
N. Menck
Z. Zilahi
F. Lakatos
J. Tomcsanyi
I. Szakal
L. Nagy
A. Nagy
E. Szolnoki
P. Andrassy
T. Sydo
A. Vorobcsuk
T. Barany
L. Koenyves
G. Simon
A. Matoltsy
E. Noori
S. Zolyomi
I. Horvath
R.G. Kiss
G. Paragh
S. Mittal
V. Rastogi
B. Shah
A. Mullasari
J.S. Krishnamoorthy
V. Mehta
A. Boro
A. Oomman
U. Kaul
S.V. Komarlu
D. Kahali
A. Bhagwat
V.M. Vijan
N.K. Ghaisas
A. Mehta
Y. Kothari
M. Scherillo
M. Vicenzi
B. Reimers
C. Panico
G. Ambrosio
S. Genovese
A. Salvioni
A. Fucili
F. Fedele
D
Douglas L. Kosmicki
Publication Details: New England Journal of Medicine, Vol.385(16)
Publisher: Massachussetts Medical Society
Identifiers: 991006253061502656
Language: English
Resource Type: Journal article