#FARXIGA FREE 30 DAY TRIAL FULL#
The full DARE-19 trial results will be presented at the American College of Cardiology Scientific Sessions in May 2021.ĭARE-19 was an international, randomised, double-blind, placebo-controlled, investigator-sponsored Phase III trial in 1,250 patients evaluating the efficacy and safety of Farxiga in addition to background local standard of care therapy in adults who are hospitalised with COVID-19 at the time of trial enrolment. The safety and tolerability profile for Farxiga at 30 days in the trial was consistent with the well-established safety profile of the medicine. We look forward to the efficacy and safety data being presented in the coming weeks.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalised patients with COVID-19 and we have now helped to fill this knowledge gap.
Also, of importance, we learned that dapagliflozin’s well-established safety profile was consistent in DARE-19.”
While the trial did not achieve statistical significance, the findings are very interesting and valuable, and will inform future clinical science. Kosiborod, M.D., 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: “DARE-19 provided important data on the potential benefits and risks of using SGLT2 inhibitors to treat hospitalised patients with COVID-19. 1,2 Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with COVID-19. The trial did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.ĭARE-19 was the first Phase III trial to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in patients hospitalised with COVID-19 who also have risk factors for developing serious complications, including hypertension (HTN), type-2 diabetes (T2D), atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4. Partnerships, alliances and recognitionĪstraZeneca and Saint Luke’s Mid America Heart Institute today announced high-level results of the primary analysis from the DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin) to treat patients hospitalised with COVID-19 who are at risk of developing serious complications.The research for Farxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys, and pancreas. The sponsor reported that the study failed to achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death) at 30 days.įarxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. In partnership with Saint Luke’s Mid America Heart Institute, the pair noted in a press release summarizing primary analysis from the DARE-19 Phase 3 clinical trial evaluating the potential of Farxiga (dapagliflozin) to treat patients hospitalized with COVID-19 who face risks for developing serious complications. British pharmaceutical company AstraZeneca reports that data resulting from a late-stage clinical trial investigating whether its diabetes drug called Farxiga can treat patients hospitalized with COVID-19 who face greater risk for serious complication failed to meet key endpoints.
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