Portal de investigação
The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Voors, AA
- Angermann, CE
- Teerlink, JR
- Collins, SP
- Kosiborod, M
- Biegus, J
- Nassif, ME
- Psotka, MA
- Tromp, J
- Borleffs, CJW
- Ma, CS
- Comin-Colet, J
- Fu, M
- Janssens, SP
- Kiss, RG
- Mentz, RJ
- Sakata, Y
- Schirmer, H
- Schou, M
- Schulze, PC
- Spinarova, L
- Volterrani, M
- Wranicz, JK
- Zeymer, U
- Zieroth, S
- Brueckmann, M
- Blatchford, JP
- Salsali, A
- Ponikowski, P
Unidades de investigação
Abstract
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.
Dados da publicação
- ISSN/ISSNe:
- 1546-170X, 1078-8956
- Tipo:
- Article
- Páginas:
- 568-574
- Link para outro recurso:
- www.scopus.com
Nature Medicine Nature Publishing Group
Citações Recebidas na Web of Science: 296
Citações Recebidas na Scopus: 522
Documentos
- Não há documentos
Filiações
Keywords
- Benzhydryl Compounds; Diabetes Mellitus, Type 2; Double-Blind Method; Glucosides; Heart Failure; Hospitalization; Humans; Sodium-Glucose Transporter 2 Inhibitors; Stroke Volume; Ventricular Function, Left; angiotensin receptor antagonist; angiotensin receptor neprilysin inhibitor; beta adrenergic receptor blocking agent; dipeptidyl carboxypeptidase inhibitor; empagliflozin; enkephalinase inhibitor; loop diuretic agent; mineralocorticoid antagonist; placebo; unclassified drug; benzhydryl derivative; empagliflozin; glucoside; acute heart failure; adult; aged; all cause mortality; Article; controlled study; diabetes mellitus; female; heart left ventricle ejection fraction; hospital admission; hospital patient; human; Kansas City Cardiomyopathy Questionnaire; major clinical study; male; multicenter study; outcome assessment; randomized controlled trial; adverse event; double blind procedure; heart failure; heart left ventricle function; heart stroke volume; hospitalization; non insulin dep
Financiamento
Proyectos asociados
Dapagliflozin, Spironolactone or Both for HFpEF (SOGALDI-PEF) - NCT05676684
Investigador Principal: João Pedro Melo Marques Pinho Ferreira
Ensaio Clínico Académico (SOGALDI-PEF) . AstraZeneca . 2022
Citar a publicação
Voors AA,Angermann CE,Teerlink JR,Collins SP,Kosiborod M,Biegus J,Ferreira JP,Nassif ME,Psotka MA,Tromp J,Borleffs CJW,Ma CS,Comin J,Fu M,Janssens SP,Kiss RG,Mentz RJ,Sakata Y,Schirmer H,Schou M,Schulze PC,Spinarova L,Volterrani M,Wranicz JK,Zeymer U,Zieroth S,Brueckmann M,Blatchford JP,Salsali A,Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat. Med. 2022. 28. (3):p. 568-574. IF:82,900. (1).
