Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, does not appear to significantly improve clinical outcomes in high-risk patients hospitalized with COVID-19.
The multicenter, randomized, double-blind, placebo-controlled DARE-19 trial (ClinicalTrials.gov: NCT04350593) evaluated the efficacy and safety of dapagliflozin in addition to standard of care in reducing disease progression, clinical complications and all-cause mortality in 1250 adults hospitalized with COVID-19. Patients were required to have at least 1 of the following risk factors for developing serious complications: hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure or chronic kidney disease stages 3-4.
The primary outcome measures included prevention of COVID-19 complications or death, (defined as the time to first occurrence of new/worsened organ dysfunction or all-cause mortality), as well as improvement in clinical status during the 30-day treatment period.
Results showed that while the safety profile was consistent, the addition of dapagliflozin was not associated with a statistically significant improvement in either outcome. Full trial data are expected to be presented at the American College of Cardiology Scientific Sessions in May 2021.
“DARE-19 provided important data on the potential benefits and risks of using SGLT2 inhibitors to treat hospitalized patients with COVID-19,” said Mikhail N. Kosiborod, MD, cardiologist at Saint Luke’s Mid America Heart Institute, Vice President of Research at Saint Luke’s Health System, and principal investigator of DARE-19. “While the trial did not achieve statistical significance, the findings are very interesting and valuable, and will inform future clinical science.”
Dapagliflozin is marketed under the brand name Farxiga and is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also approved to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
Update on the DARE-19 phase III trial for Farxiga in COVID-19. [press release]. AstraZeneca and Saint Luke’s Mid American Heart Institute; April 12, 2021.