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

Milton Packer 1 Javed Butler 2 Faiez Zannad 3, 4, 5 Gerasimos Filippatos 6, 7 Joao Pedro Ferreira 3, 4, 5, 8 Stuart J Pocock 9 Peter Carson 10 Inder Anand 11 Wolfram Doehner 12, 13, 14 Markus Haass 15 Michel Komajda 16 Alan Miller 17 Steen Pehrson 18 John R Teerlink 19, 20 Sven Schnaidt 21 Cordula Zeller 21 Janet M Schnee 21 Stefan D Anker 12, 13, 14 
Abstract : Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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https://hal.univ-lorraine.fr/hal-03358043
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Submitted on : Wednesday, September 29, 2021 - 10:37:05 AM
Last modification on : Friday, April 22, 2022 - 11:42:06 AM
Long-term archiving on: : Thursday, December 30, 2021 - 6:34:44 PM

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Milton Packer, Javed Butler, Faiez Zannad, Gerasimos Filippatos, Joao Pedro Ferreira, et al.. Effect of Empagliflozin on Worsening Heart Failure Events in Patients with Heart Failure and a Preserved Ejection Fraction: The EMPEROR-Preserved Trial. Circulation, American Heart Association, 2021, ⟨10.1161/CIRCULATIONAHA.121.056824⟩. ⟨hal-03358043⟩

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