AstraZeneca’s (AZ) SGLT-2 inhibitor Farxiga showed no significant benefit for hospitalised COVID-19 patients, according to new detailed results presenting at the annual American College of Cardiology (ACC) meeting.
SGLT2 inhibitors – such as Farxiga (dapagliflozin) – can be used to provide organ protection for patients with chronic conditions, such as heart failure and diabetes.
Researchers hypothesised that Farxiga could be used for the treatment of the sickest COVID-19 patients, after discovering early in the pandemic that the disease affects multiple organ systems – including the heart and kidneys.
As a result of this hypothesis, AZ launched the phase 3 DARE-19 trial to evaluate Farxiga in hospitalised COVID-19 patients with comorbidities that increased their risk of developing complications from the virus – including diabetes, chronic kidney disease and heart failure.
Results from this study showed that 11.2% of hospitalised COVID-19 patients who received Farxiga experienced an organ failure or died after 30 days of treatment versus 13.8% in the placebo group.
Despite being unable to demonstrate any significant benefit in these patients, researchers highlighted that Farxiga’s results were “directionally favourable” compared with placebo on all organ failure events.
AZ’s drug also showed a comparable safety profile to placebo and was found to have numerically fewer serious effects than placebo in the DARE-19 trial.
“Our study generates a hypothesis that [Farxiga] may offer organ protection in acutely ill patients who are hospitalised with COVID-19, but we were not able to prove this beyond a reasonable doubt because patient outcomes rapidly improved during the study period, making it much harder to accrue enough events and reach statistical certainty,” said Mikhail Kosiborod, principle research for the DARE-19 study.
“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 [Farxiga]’s well-established safety profile was consistent in DARE-19,” he added.
Earlier this month, Farxiga received US Food and Drug Administration (FDA) approval for the treatment of chronic kidney disease (CKD) in patients at risk of progression, both with or without type 2 diabetes.
Initially, Farxiga was approved in 2014 to improve glycemic control in adults with type 2 diabetes when administered alongside diet improvements and exercise.