Update on the DARE-19 Phase III trial for Farxiga in COVID-19

AstraZeneca and Saint Luke’s Mid America Heart Institute today announced high-level results of the primary analysis from the DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin) to treat patients hospitalised with COVID-19 who are at risk of developing serious complications.

The trial did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.

DARE-19 was the first Phase III trial to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in patients hospitalised with COVID-19 who also have risk factors for developing serious complications, including hypertension (HTN), type-2 diabetes (T2D), atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4.^1,2 Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with COVID-19.^3,4

Mikhail N. Kosiborod, M.D., 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, said: “DARE-19 provided important data on the potential benefits and risks of using SGLT2 inhibitors to treat hospitalised patients with COVID-19. While the trial did not achieve statistical significance, the findings are very interesting and valuable, and will inform future clinical science. Also, of importance, we learned that dapagliflozin’s well-established safety profile was consistent in DARE-19.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalised patients with COVID-19 and we have now helped to fill this knowledge gap. We look forward to the efficacy and safety data being presented in the coming weeks.”

The safety and tolerability profile for Farxiga at 30 days in the trial was consistent with the well-established safety profile of the medicine.

The full DARE-19 trial results will be presented at the American College of Cardiology Scientific Sessions in May 2021.