Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

作者：Scott D. Solomon, John J.V. McMurray, Brian Claggett, Rudolf A. de Boer, David L. DeMets, Adrian F. Hernandez, Silvio E. Inzucchi, Mikhail Kosiborod, Carolyn S.P. Lam, Felipe A. Martínez, Sanjiv J. Shah, Akshay S. Desai, Pardeep S. Jhund, Jan Bělohlávek, Chern‐En Chiang, C. Jan Willem Borleffs, Josep Comín‐Colet, Dan Dobreanu, Jarosław Dróżdż, James C. Fang, Marco A. Alcocer‐Gamba, Waleed Al Habeeb, Yaling Han, Jose Walter Cabrera Honorio, Stefan Janssens, Tzvetana Katova, Masafumi Kitakaze, Béla Merkely, Eileen O’Meara, José Francisco Kerr Saraiva, С. Н. Терещенко, Jorge Thierer, Muthiah Vaduganathan, Orly Vardeny, Subodh Verma, Vinh Pham, Ulrica Wilderäng, Natalia Zaozerska, Erasmus Bachus, Daniel Lindholm, Magnus Petersson, Anna Maria Langkilde · 发表于：New England Journal of Medicine · 年份：2022 · DOI：10.1056/nejmoa2206286 · 被引用次数：2859 · 研究领域：Diabetes Treatment and Management、Hyperglycemia and glycemic control in critically ill and hospitalized patients、Heart Failure Treatment and Management

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. R...