TY - JOUR
T1 - Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
AU - DELIVER Trial Committees and Investigators
AU - Solomon, Scott D.
AU - McMurray, John J.V.
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. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
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. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
KW - Benzhydryl Compounds/adverse effects
KW - Diabetes Mellitus, Type 2/complications
KW - Glucosides/adverse effects
KW - Heart Failure/complications
KW - Humans
KW - Sodium-Glucose Transporter 2 Inhibitors/adverse effects
KW - Stroke Volume/drug effects
KW - Ventricular Function, Left/drug effects
UR - http://www.scopus.com/inward/record.url?scp=85138185629&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.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 -
