EMPULSE
Trial question
What is the role of empagliflozin in patients hospitalized for acute HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 530
530 patients (179 female, 351 male).
Inclusion criteria: patients with a primary diagnosis of acute de novo or decompensated chronic HF regardless of LVEF.
Key exclusion criteria: cardiogenic shock; PE; current hospitalization for acute HF primarily triggered by PE, cerebrovascular accident, or acute MI.
Interventions
N=265 empagliflozin (at a dose of 10 mg/day).
N=265 placebo (matching placebo).
Primary outcome
Clinical benefit at day 90
53.89%
39.71%
53.9 %
40.4 %
26.9 %
13.5 %
0.0 %
Empagliflozin
Placebo
Significant
increase ▲
NNH = 7
Significant increase in clinical benefit at day 90 (53.89% vs. 39.71%; AD 14%, 95% CI 4.14 to 23.86).
Secondary outcomes
No significant difference in CV death or hospitalization for HF (12.8% vs. 18.5%; HR 0.69, 95% CI 0.45 to 1.08).
No significant difference in improvement of ≥ 10 points in Kansas City Cardiomyopathy Questionnaire-total symptom score at day 90 (83.1% vs. 76.3%; OR 1.522, 95% CI 0.93 to 2.5).
Significantly greater improvement in Kansas City Cardiomyopathy Questionnaire-total symptom score at day 90 (36.19 points vs. 31.73 points; AD 4.45 points, 95% CI 0.32 to 8.59).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with a primary diagnosis of acute de novo or decompensated chronic HF regardless of LVEF, empagliflozin was superior to placebo with respect to clinical benefit at day 90.
Reference
Adriaan A Voors, Christiane E Angermann, John R Teerlink et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574.
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