Empagliflozin of little benefit in patients hospitalized for COVID-19

In patients who are hospitalized for COVID-19, treatment with empagliflozin does not appear to have any positive impact on outcomes such as 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death, as shown in the open-label RECOVERY trial.

RECOVERY randomly assigned 4,271 patients to receive either usual standard of care alone (n=2,158) or usual standard of care plus oral empagliflozin 10 mg once daily (n=2,113) for 28 days or until discharge. The primary endpoint was 28-day mortality, while secondary endpoints included duration of hospitalization and the composite of invasive mechanical ventilation or death.

The mean age of the cohort was 61.5 years, and the median time since symptom onset was 8 days. At baseline, the majority of the patients (90 percent) were receiving corticosteroids, approximately a quarter were receiving remdesivir, and about a quarter were previously treated with tocilizumab.

Death within 28 days occurred in 14 percent of patients in the empagliflozin group and in 14 percent of those in the usual-care group (rate ratio [RR], 0.96, 95 percent confidence interval [CI], 0.82–1.13; p=0.64).

No significant between-group difference was observed in duration of hospitalization (median, 8 days for both groups) or the proportion of patients discharged from hospital alive within 28 days (79 percent in the empagliflozin group vs 78 percent in the usual-care group; RR, 1.03, 95 percent CI, 0.96–1.10; p=0.44).

Among patients who did not require invasive mechanical ventilation at baseline, treatment with empagliflozin did not reduce the risk of the composite endpoint of invasive mechanical ventilation or death (16 percent vs 17 percent in the usual-care group; RR, 0.95, 95 percent CI, 0.84–1.08; p=0.44).

Two serious adverse events considered to be related to empagliflozin treatment were documented, with both being ketosis without acidosis.

The findings suggest that empagliflozin should not be indicated for the treatment of COVID-19 patients, unless there is an established indication due to a different condition such as diabetes, according to the researchers.