6/28/23, 9:56 PM EMPEROR-Preserved Pathway Feedback Search Clinical Topics Home Studies EMPEROR Preserved EMPEROR Preserved Disease Heart failure Trial question What is the role of empagliflozin in patients with HFpEF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 45.0% female N = 5988 55.0% male 5988 patients (2676 female, 3312 male) Inclusion criteria: patients with NYHA class II-IV HF and an ejection fraction > 40% Key exclusion criteria: myocardial infarction; major cardiovascular surgery, or stroke in past 90 days; heart transplant; acute decompensated HF; indication for liver disease; impaired renal function Interventions N=2997 empagliflozin (10 mg once daily plus usual therapy) N=2991 placebo (matching placebo plus usual care) Primary outcome Cardiovascular death or hospitalization for heart failure 17.1 % 17.1 13.8 12.8 % https://web.pathway.md/studies/recoc9ovpunItjZE8 1/2 6/28/23, 9:56 PM EMPEROR-Preserved Pathway 8.6 % Significant decrease 4.3 % NNT = 30 0.0 % Empagliflozin Placebo Significant decrease in cardiovascular death or hospitalization for HF (13.8% vs. 17.1%; HR 0.79, 95% CI 0.69 to 0.9) Secondary outcomes Significant decrease in hospitalization for HF (8.6% vs. 11.8%; HR 0.71, 95% CI 0.6 to 0.83) No significant difference in cardiovascular death (7.3% vs. 8.2%; HR 0.91, 95% CI 0.76 to 1.09) Significant increase in the incidence of improvement in GFR (-1.25 mL/min/1.73 m /year vs. -2.62 mL/min/1.73 m /year; HR 1.36, 95% CI 1.06 to 1.66) Safety outcomes No significant difference in serious adverse events and adverse events leading to discontinuation of trial drug. Conclusion In patients with NYHA class II-IV HF and an ejection fraction > 40%, empagliflozin was superior to placebo with respect to cardiovascular death or hospitalization for HF. Reference Stefan D Anker, Javed Butler, Gerasimos Filippatos et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. Open reference URL https://web.pathway.md/studies/recoc9ovpunItjZE8 2/2