Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
22 09 2022
22 09 2022
Historique:
pubmed:
27
8
2022
medline:
24
9
2022
entrez:
26
8
2022
Statut:
ppublish
Résumé
Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P<0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
Sections du résumé
BACKGROUND
Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain.
METHODS
We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis.
RESULTS
Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P<0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups.
CONCLUSIONS
Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
Identifiants
pubmed: 36027570
doi: 10.1056/NEJMoa2206286
doi:
Substances chimiques
Benzhydryl Compounds
0
Glucosides
0
Sodium-Glucose Transporter 2 Inhibitors
0
dapagliflozin
1ULL0QJ8UC
Banques de données
ClinicalTrials.gov
['NCT03619213']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1089-1098Investigateurs
Scott D Solomon
(SD)
John J V McMurray
(JJV)
Rudolf A de Boer
(RA)
David DeMets
(D)
Adrian F Hernandez
(AF)
Silvio E Inzucchi
(SE)
Mikhail N Kosiborod
(MN)
Carolyn S P Lam
(CSP)
Felipe Martinez
(F)
Sanjiv J Shah
(SJ)
Anna Maria Langkilde
(AM)
Magnus Petersson
(M)
Daniel Lindholm
(D)
Ulrica Wilderäng
(U)
Olof Bengtsson
(O)
Ann Nilsson
(A)
Barbara Kucharczuk-Filipek
(B)
Marc Pfeffer
(M)
Stuart Pocock
(S)
Karl Swedberg
(K)
Jean L Rouleau
(JL)
Nish Chaturvedi
(N)
Peter Ivanovich
(P)
Andrew Levey
(A)
Akshay Desai
(A)
Pardeep Jhund
(P)
Peter Finn
(P)
Abdel Brahimi
(A)
Martina McGrath
(M)
Ebrahim Barkoudah
(E)
Finnian McCausland
(F)
Eugene Connolly
(E)
Ninian Lang
(N)
Mark Petrie
(M)
Christian Ruff
(C)
Sara Alexanian
(S)
Rajesh K Garg
(RK)
Marie E McDonnell
(ME)
Adrian Hernandez
(A)
Jorge Thierer
(J)
Stefan P Janssens
(SP)
Jose Francisco Kerr Saraiva
(JF)
Tsvetana Katova
(T)
Subodh Verma
(S)
Eileen O'Meara
(E)
Yaling Han
(Y)
Jan Belohlavek
(J)
Bela Merkely
(B)
Masafumi Kitakaze
(M)
Marco Antonio Alcocer Gamba
(MA)
C Jan Willem Borleffs
(CJW)
Jose Walter Cabrera Honorio
(JW)
Jaroslaw Drozdz
(J)
Dan Dobreanu
(D)
Sergey N Tereschenko
(SN)
Waleed Al Habeeb
(W)
Josep Comin-Colet
(J)
Chern-En Chiang
(CE)
Jim Fang
(J)
Orly Vardeny
(O)
Pham Nguyen Vinh
(PN)
Juan Loureyro
(J)
Diego Besada
(D)
Eduardo Perna
(E)
Paula Perez Terns
(P)
Daniela García Brasca
(D)
Diego Aizenberg
(D)
Guillermo Mercau
(G)
Andres Alvarisqueta
(A)
Cesar Zaidman
(C)
Mariana Ruiz
(M)
Oscar Montaña
(O)
Viviana Arias
(V)
Sanatorio Junin
(S)
Diego Martinez
(D)
Natalia Cluigt
(N)
Miguel Hominal
(M)
Sonia Sassone
(S)
Alberto Liberman
(A)
Claudio Majul
(C)
Rubén García Durán
(R)
Fredy Ferre Pacora
(F)
Anne Pouleur
(A)
Stefan Janssens
(S)
Rachid Maamar
(R)
Walter Smolders
(W)
Philippe Vanduynhoven
(P)
David Derthoo
(D)
Adrian Paulo Moralles Kormann
(AP)
Fabio Tuche
(F)
Renner Lariucci
(R)
Mauro Esteves Hernandes
(M)
Paulo Ernesto Leaes
(PE)
Dalton Bertolim Precoma
(DB)
Maria Helena Vidotti
(MH)
Lidia Zytynski Moura
(LZ)
Adamastor Humberto Pereira
(AH)
Gilmar Reis
(G)
Nikolai Runev
(N)
Nikolay Iliev
(N)
Yuliyana Ivanova
(Y)
Atanas Mihov
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(M)
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(T)
Vladimir Zhelev
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Antoni Gogov
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Dimitar Karageorgiev
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Georgi Stanchev
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Daniela Tsonkova-Dobreva
(D)
Ralitsa Vatova
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Danail Avramov
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(YT)
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