TY - JOUR

T1 - The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure

T2 - a multinational randomized trial

AU - Voors, Adriaan A.

AU - Angermann, Christiane E.

AU - Teerlink, John R.

AU - Collins, Sean P.

AU - Kosiborod, Mikhail

AU - Biegus, Jan

AU - Ferreira, Joao Pedro

AU - Nassif, Michael E.

AU - Psotka, Mitchell A.

AU - Tromp, Jasper

AU - Borleffs, C. Jan Willem

AU - Ma, Changsheng

AU - Comin-Colet, Joseph

AU - Fu, Michael

AU - Janssens, Stefan P.

AU - Kiss, Robert G.

AU - Mentz, Robert J.

AU - Sakata, Yasushi

AU - Schirmer, Henrik

AU - Schou, Morten

AU - Schulze, P. Christian

AU - Spinarova, Lenka

AU - Volterrani, Maurizio

AU - Wranicz, Jerzy K.

AU - Zeymer, Uwe

AU - Zieroth, Shelley

AU - Brueckmann, Martina

AU - Blatchford, Jonathan P.

AU - Salsali, Afshin

AU - Ponikowski, Piotr

PY - 2022/3

Y1 - 2022/3

N2 - The sodium-glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; P =0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment.

AB - The sodium-glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; P =0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment.

KW - MORTALITY

KW - HF

U2 - 10.1038/s41591-021-01659-1

DO - 10.1038/s41591-021-01659-1

M3 - Journal article

C2 - 35228754

VL - 28

SP - 568

EP - 574

JO - Nature Medicine

JF - Nature Medicine

SN - 1078-8956

IS - 3

ER -