British drug major AstraZeneca Plc (AZN,AZN.L) Monday announced that its DARE-19 Phase III trial for Farxiga (dapagliflozin) in COVID-19 did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality.
The trial also failed to achieve statistical significance for the primary endpoint of recovery measuring a change in clinical status, i.e., from early recovery to death, at 30 days.
Mikhail Kosiborod, 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, “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.”
AstraZeneca and Saint Luke’s Mid America Heart Institute together announced the high-level results of the primary analysis from the trial assessing the potential of Farxiga to treat patients hospitalised with COVID-19 who are at risk of developing serious complications.
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 company noted that the DARE-19 was the first Phase III trial to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 or SGLT2 inhibitor in patients hospitalised with COVID-19 who also have risk factors for developing serious complications. These include hypertension, type-2 diabetes, atherosclerotic cardiovascular disease, heart failure or chronic kidney disease Stages 3-4.
Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with COVID-19.
The company will present the full DARE-19 trial results at the American College of Cardiology Scientific Sessions in May 2021.
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