DARE-19 PHASE III SHOWS TREATMENT’S WELL-ESTABLISHED SAFETY PROFILE CONSISTENT IN COVID-19 PATIENTS

KUALA LUMPUR, July 30 (Bernama) -- The findings of DARE-19, a double-blind, placebo-controlled Phase III trial examining Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19, have been published in The Lancet Diabetes & Endocrinology. 

The study was a collaboration of George Clinical, a global scientifically-backed clinical research organisation and Saint Luke’s Mid America Heart Institute and was funded by AstraZeneca, according to a statement.

“In a month, we broke down barriers to go from concept to our first patient in the trial, and the team displayed extraordinary commitment needed to successfully manage this research during this pandemic personally and professionally,” said George Clinical Chief Business Officer, Sean Hart. 

Prior to the study, it was established that patients hospitalised with COVID-19 with cardiometabolic risk factors had an elevated risk of organ failure and death.

DARE-19 was the first large, randomised controlled study of hospitalised patients with COVID-19 to evaluate the safety and efficacy of SGLT2 inhibitors.

Detailed results from the primary analysis of the DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to treat patients hospitalised with COVID-19 who are at risk of developing serious complications, showed the trial did not achieve statistical significance for the two primary endpoints. 

However, there were numerically fewer events of death or new or worsened organ dysfunction in the Farxiga group compared with placebo.

The primary endpoint of prevention was defined as new or worsened respiratory, cardiovascular or kidney organ dysfunction during hospitalisation or death from any cause during the 30-day treatment period.

Numerically fewer events were observed in the Farxiga group across all components of this composite endpoint. Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with COVID-19.

 The second primary endpoint of recovery, which assessed change in clinical status (improvement or deterioration) compared to baseline, showed no overall difference between the treatment groups. 

More details at https://www.georgeclinical.com.

-- BERNAMA