AstraZeneca's phase 3 trial for Farxiga diabetes drug fails in patients with COVID-19

AstraZeneca on Sunday announced that its diabetes drug Farxiga (dapagliflozin) failed to treat patients hospitalized with COVID-19 who were at risk of developing serious complications. The firm tested Farxiga on at least 1,250 high-risk patients. “The trial did not achieve statistical significance for prevention of organ dysfunction and all-cause of COVID-19 mortality,” AstraZeneca announced in a press release. The pharmaceutical company intimated the Phase III trial named DARE-19 to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in patients hospitalized with COVID-19. 

“The safety and tolerability profile for Farxiga at 30 days in the trial was consistent with the well-established safety profile of the medicine,” AstraZeneca said in a statement. 

The drug Farxiga was administered to the vulnerable group at risk of developing serious COVID-19 complications. This included those that suffered from diabetes, hypertension, cardiovascular disease (ASCVD), heart failure or chronic kidney disease, or cardiac, renal, and metabolic comorbidities. The drug however had “poor outcomes” and did not prove to be effective in preventing COVID-19 related fatalities in hospitalized patients. Farxiga (or dapagliflozin) is an oral drug that was tested by AstraZeneca to establish its cardiorenal effects on prevention and organ protection among the people with comorbidities who were infected with COVID-19. The drug has been widely used by the medical fraternity as it reduced the risk of hospitalization for heart failure or death in patients with cardiovascular problems. 

Executive Vice President at BioPharmaceuticals R&D, Mene Pangalos, said: “Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalized 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.”

Risks of using Farxiga revealed

DARE-19 provided important data on the potential benefits and risks of using Farxiga to treat hospitalized patients with COVID-19, Mikhail N. Kosiborod, M.D., a 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. Kosiborod stressed, “While the trial did not achieve statistical significance, the findings are very interesting and valuable, and will inform future clinical science.” He further continued that the trial revealed the drug’s safety profile during DARE-19.

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