RECOVERY (empagliflozin)
Trial question
What is the role of empagliflozin in patients hospitalized with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 4271
4271 patients (1606 female, 2665 male).
Inclusion criteria: patients hospitalized with COVID-19.
Key exclusion criteria: age < 18 years; pregnancy; T1DM; history of ketoacidosis; T2DM with ketosis.
Interventions
N=2113 empagliflozin (at a dose of 10 mg/day and standard of care for 28 days).
N=2158 usual care (standard of care only for 28 days).
Primary outcome
All-cause mortality at day 28
13.7%
14.2%
14.2 %
10.6 %
7.1 %
3.5 %
0.0 %
Empagliflozin
Usual
care
No significant
difference ↔
No significant difference in all-cause mortality at day 28 (13.7% vs. 14.2%; HR 0.96, 96% CI 0.82 to 1.13).
Secondary outcomes
No significant difference in the rate of discharged from hospital within 28 days (79.4% vs. 77.7%; HR 1.03, 95% CI 0.96 to 1.1).
No significant difference in receipt of invasive mechanical ventilation or death (16.2% vs. 17.3%; RR 0.95, 95% CI 0.84 to 1.08).
No significant difference in RRT (2.1% vs. 2.1%; RR 0.96, 96% CI 0.64 to 1.45).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients hospitalized with COVID-19, empagliflozin was not superior to usual care with respect to all-cause mortality at day 28.
Reference
RECOVERY Collaborative Group. Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes Endocrinol. 2023 Dec;11(12):905-914.
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