TY - JOUR
T1 - Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
AU - Solomon, Scott D.
AU - McMurray, John J.V.
AU - DELIVER Trial Committees and Investigators
AU - Claggett, Brian
AU - de Boer, Rudolf A.
AU - DeMets, David
AU - Hernandez, Adrian F.
AU - Inzucchi, Silvio E.
AU - Kosiborod, Mikhail N.
AU - Lam, Carolyn S.P.
AU - Martinez, Felipe
AU - Shah, Sanjiv J.
AU - Desai, Akshay S.
AU - Jhund, Pardeep S.
AU - Belohlavek, Jan
AU - Chiang, Chern En
AU - Borleffs, C. Jan Willem
AU - Comin-Colet, Josep
AU - Dobreanu, Dan
AU - Drozdz, Jaroslaw
AU - Fang, James C.
AU - Alcocer-Gamba, Marco Antonio
AU - Al Habeeb, Waleed
AU - Han, Yaling
AU - Honorio, Jose Walter Cabrera
AU - Janssens, Stefan P.
AU - Katova, Tzvetana
AU - Kitakaze, Masafumi
AU - Merkely, Béla
AU - O'Meara, Eileen
AU - Saraiva, Jose Francisco Kerr
AU - Tereshchenko, Sergey N.
AU - Thierer, Jorge
AU - Vaduganathan, Muthiah
AU - Vardeny, Orly
AU - Verma, Subodh
AU - Pham, Vinh Nguyen
AU - Wilderäng, Ulrica
AU - Zaozerska, Natalia
AU - Bachus, Erasmus
AU - Lindholm, Daniel
AU - Petersson, Magnus
AU - Langkilde, Anna Maria
N1 - Funding Information:
Supported by AstraZeneca .
Publisher Copyright:
Copyright © 2022 Massachusetts Medical Society.
PY - 2022/9/22
Y1 - 2022/9/22
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85138185629&partnerID=8YFLogxK
U2 - 10.1056/nejmoa2206286
DO - 10.1056/nejmoa2206286
M3 - Article
C2 - 36027570
AN - SCOPUS:85138185629
SN - 0028-4793
VL - 387
SP - 1089
EP - 1098
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 12
ER -