EMPEROR-Preserved
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
55.0% male
N = 5988
5988 patients (2676 female, 3312 male).
Inclusion criteria: patients with NYHA class II-IV HF and an ejection fraction > 40%.
Key exclusion criteria: MI; 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
CV death or hospitalization for heart failure
13.8%
17.1%
17.1 %
12.8 %
8.6 %
4.3 %
0.0 %
Empagliflozin
Placebo
Significant
decrease ▼
NNT = 30
Significant decrease in CV 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 CV 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 m²/year vs. -2.62 mL/min/1.73 m²/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 CV 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.
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