Effect of Empagliflozin on Worsening Heart Failure Events in Patients with Heart Failure and a Preserved Ejection Fraction: The EMPEROR-Preserved Trial

• Type: Article in International Scientific Journal
• Date: 2021

Authors

Packer, M (Author) Other; Butler, J (Author) Other; Zannad, F (Author) Other; Filippatos, G (Author) Other; Ferreira, JP (Author) FMUP; Pocock, SJ (Author) Other; Carson, P (Author) Other; Anand, I (Author) Other; Doehner, W (Author) Other; Haass, M (Author) Other; Komajda, M (Author) Other; Miller, A (Author) Other; Pehrson, S (Author) Other; Teerlink, JR (Author) Other; Schnaidt, S (Author) Other; Zeller, C (Author) Other; Schnee, JM (Author) Other; Anker, SD (Author) Other

Journal

Title: Circulation

ISSN: 0009-7322

Publisher: Wolters Kluwer Health

Other information

Authenticus ID: P-00V-B49

DOI: 10.1161/circulationaha.121.056824

Abstract (EN): <jats:p> <jats:bold>Background:</jats:bold> Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events. </jats:p> <jats:p> <jats:bold>Methods:</jats:bold> We randomly assigned 5988 patients with class II-IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite endpoints. </jats:p> <jats:p> <jats:bold>Results:</jats:bold> Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (432 vs 546 patients; empagliflozin vs placebo, respectively; hazard ratio 0.77, 95% CI: 0.67-0.87), P <0.0001. This benefit reached statistical significance at 18 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio 0.71, 95% CI 0.52-0.96, P=0.028) and the total number of all hospitalizations that required a vasopressor or positive inotropic drug (hazard ratio 0.73, 95% CI: 0.55-0.97,P=0.033). As compared with placebo, fewer patients in the empagliflozin group reported outpatient intensification of diuretics (482 vs 610, hazard ratio 0.76, 95% CI: 0.67-0.86, P<0.0001), and patients assigned to empagliflozin were 20-50% more likely to have a better NYHA functional class, with significant effects at 12 weeks that were maintained for at least 2 years. The benefit on total heart failure hospitalizations was similar in patients with an ejection fraction of >40-<50% and 50-<60%, but was attenuated at higher ejection fractions. </jats:p> <jats:p> <jats:bold>Conclusions:</jats:bold> In patients with heart failure and a preserved ejection fraction, empagliflozin produced a meaningful, early and sustained reduction in the risk and severity of a broad range of inpatient and outpatient worsening heart failure events. </jats:p> <jats:p> <jats:bold>Clinical Trial Registration:</jats:bold> The registration identifier at ClinicalTrials.gov is NCT03057977 </jats:p>

Language: English

Type (Professor's evaluation): Dissemination