DARE-19: Dapagliflozin Does Not Reduce Organ Failure in COVID-19 Patients

In high-risk patients hospitalized with COVID-19, the administration of the SGLT2 inhibitor dapagliflozin was not associated with a reduction in organ failure or mortality, according to a new study presented at the American College of Cardiology Scientific Session (ACC.21).

“We already know that SGLT2 inhibitors provide organ protection in patients with Type 2 diabetes, heart failure and chronic kidney disease, and these are the exact same patients who if they contract COVID-19 are at high risk to be hospitalized with serious illness and develop complications, such as organ failure,” principal investigator Mikhail Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, vice president for Research at Saint Luke’s Health System in Kansas City, Missouri, said in a news release. “Accordingly, we wanted to see if dapagliflozin may also help with organ protection in patients with cardiometabolic risk factors who are acutely ill and require hospitalization due to COVID-19.”

The study included 1,250 patients hospitalized with COVID-19 across 95 sites between April 2020 and January 2021. Patients were randomized at 1:1 to receive dapagliflozin 10 mg once daily or placebo. Patients were given treatment no later than four days after hospital admittance. Treatment was continued for 30 days. The primary endpoint of interest was organ failure or death.

The primary endpoint occurred in 11.2% of patients taking dapagliflozin vs. 13.8% taking placebo. The mortality rate was 6.6% in the dapagliflozin group vs. 8.6% taking placebo. Although the trend for benefit was seen in the dapagliflozin arm, the differences did not attain statistical significance.

“Our study generates a hypothesis that dapagliflozin may offer organ protection in acutely ill patients who are hospitalized with COVID-19, but we were not able to prove this beyond a reasonable doubt because patient outcomes rapidly improved during the study period, making it much harder to accrue enough events and reach statistical certainty,” Dr. Kosiborod said of the results.

Additional follow-up data out to 90 days is being evaluated.

Kosiborod M. Effects of Dapagliflozin on Prevention of Major Clinical Events and Recovery in Patients with Respiratory Failure due to COVID-19 – Main Results from the DARE-19 Randomized Trial. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021.