AstraZeneca’s (AZ) diabetes and heart failure drug dapagliflozin (Farxiga) did not produce significant results in its phase 3 DARE-19 trial conducted for treating high-risk patients hospitalised with COVID-19, announced the company.
The trial found that giving dapagliflozin to treat patients hospitalised with COVID-19 who were at risk of developing serious complications, did not achieve statistical significance for the primary endpoints of reducing organ dysfunction and all-cause mortality, nor did it boost recovery.
Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. The drug has been approved for the treatment of patients with chronic kidney disease (CKD) and also for heart failure in patients with reduced ejection fraction (HFrEF). It was found to significantly reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with HFrEF.
The DARE-19 trial was conducted to develop new treatments and re-purpose existing drugs to prevent and treat COVID-19. The trial tested the drug for its potential to treat patients hospitalised with COVID-19 who had risk factors for developing serious complications including hypertension, type 2 diabetes (T2D), atherosclerotic cardiovascular disease, heart failure and chronic kidney disease.
During the trial, the drug was given over a 30-day period to 1,250 COVID-19 patients with illnesses including high blood pressure, T2D, heart failure and chronic kidney disease in addition to standard care.
While the drug failed to make any meaningful impact on patient outcomes, it was not found to cause an increased risk of diabetic ketoacidosis in any patients hospitalised with COVID-19.
“DARE-19 provided important data on the potential benefits and risks of using SGLT2 inhibitors to treat hospitalised patients with COVID-19,” said DARE-19’s lead investigator Mikhail Kosiborod.