The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial.
Carolyn S P LamChristiane E AngermannJohn R TeerlinkSean P CollinsMikhail Naum KosiborodJan BiegusJoão Pedro FerreiraMichael E NassifMitchell A PsotkaJasper TrompC Jan Willem BorleffsChangsheng MaJoseph Comin-ColetMichael FuStefan P JanssensRobert G KissRobert J MentzYasushi SakataHenrik SchirmerMorten SchouP Christian SchulzeLenka SpinarovaMaurizio VolterraniJerzy Krzysztof WraniczUwe ZeymerShelley ZierothMartina BrueckmannJonathan P BlatchfordAfshin SalsaliPiotr PonikowskiPublished in: Nature medicine (2022)
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.
Keyphrases
- ejection fraction
- heart failure
- aortic stenosis
- acute heart failure
- end stage renal disease
- newly diagnosed
- clinical trial
- healthcare
- emergency department
- type diabetes
- prognostic factors
- phase iii
- metabolic syndrome
- liver failure
- intensive care unit
- randomized controlled trial
- atrial fibrillation
- skeletal muscle
- coronary artery disease
- weight loss
- patient reported
- combination therapy
- acute respiratory distress syndrome
- smoking cessation
- hypertrophic cardiomyopathy
- aortic dissection
- replacement therapy