AstraZeneca announced positive results from the landmark Part III DAPA-HF trial which confirmed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-important and clinically-meaningful reduction of cardiovascular demise or the worsening of heart failure (outlined as hospitalization or an urgent heart failure visit), compared to placebo. The trial was performed in sufferers with reduced ejection fraction (HFrEF) on the standard of care remedy, including those with and without type-2 diabetes.
The safety profile of Farxiga within the DAPA-HF trial was in keeping with the well-established safety profile of the medication.
Executive Vice President, BioPharmaceuticals R&D, Mene Pangalos, mentioned: “With the DAPA-HF trial, Farxiga becomes the first in its class to display efficacy and safety data for the therapy of sufferers with heart failure, with/without type-2 diabetes, on top of standard of care. Today, half of heart failure sufferers will die inside five years of prognosis, and it stays one of many major causes of hospitalization. We look ahead to discussing the results of DAPA-HF with health officials as quickly as possible.”
John McMurray, MD, Cardiovascular Research Centre Glasglow, Institute of Cardiovascular and Medical Sciences mentioned: “The advantages of dapagliflozin in DAPA-HF are very effective, with a substantial discount within the major composite consequence of cardiovascular death or hospital admission. We hope these thrilling new findings will finally assist in reducing the terrible burden of illness caused by heart failure and assisting enhance outcomes for our patients.”
DAPA-HF is the first heart failure results trial with an SGLT2 inhibitor examining the therapy of heart failure in adults with HFrEF on standard of care (which incorporates medicines such as angiotensin-changing enzyme [ACE] inhibitors, angiotensin II receptor blockers [ARB], beta-blockers, mineralocorticoid-receptor antagonists [MRAs] and neprilysin inhibitors), in patients with and without type-2 diabetes.
The full DAPA-HF trial outcomes will be submitted for presentation at a forthcoming medical assembly.
Farxiga is also being investigated in patients with heart failure with preserved ejection fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF) trials.