EMPEROR-Reduced
Trial question
What is the role of empagliflozin in patients with HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 3730
3730 patients (893 female, 2837 male).
Inclusion criteria: adult patients with chronic HF and an ejection fraction ≤ 40% who were receiving recommended therapy.
Key exclusion criteria: MI, major cardiovascular surgery or stroke in the past 90 days; heart transplant recipient; acute decompensated HF; symptomatic hypotension; indication of liver disease; impaired renal function.
Interventions
N=1863 empagliflozin (at a dose of 10 mg once daily).
N=1867 placebo (matching placebo).
Primary outcome
CV death or hospitalization for worsening heart failure
19.4%
24.7%
24.7 %
18.5 %
12.3 %
6.2 %
0.0 %
Empagliflozin
Placebo
Significant
decrease ▼
NNT = 18
Significant decrease in CV death or hospitalization for worsening HF (19.4% vs. 24.7%; HR 0.75, 95% CI 0.65 to 0.86).
Secondary outcomes
Significant decrease in total hospitalizations for HF (388 events vs. 553 events; HR 0.7, 95% CI 0.58 to 0.85).
Significant decrease in the incidence of eGFR decline (0.55 mL/min/1.73 m²/year vs. 2.28 mL/min/1.73 m²/year; AD -1.73 mL/min/1.73 m²/year, 95% CI -1.1 to -2.37).
No significant difference in death from any cause (13.4% vs. 14.2%; HR 0.92, 95% CI 0.77 to 1.1).
Safety outcomes
No significant difference in adverse effects.
Significant difference in serious renal outcome (1.6% vs. 3.1%).
Conclusion
In adult patients with chronic HF and an ejection fraction ≤ 40% who were receiving recommended therapy, empagliflozin was superior to placebo with respect to CV death or hospitalization for worsening HF.
Reference
Milton Packer, Stefan D Anker, Javed Butler et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424.
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