AstraZeneca has announced positive results from the Phase III DAPA-HF trial which showed that FARXIGA (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type 2 diabetes.
The safety profile of FARXIGA in the DAPA-HF trial was consistent with the well-established safety profile of the medicine.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “With the DAPA-HF trial, FARXIGA becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type 2 diabetes, on top of standard of care. Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible.” FARXIGA is not indicated to reduce the risk of heart failure or CV death.
John McMurray, University of Glasgow, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences said: “The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission. We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients.”
DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in adults with HFrEF on top of standard of care (which includes medicines such as angiotensin-converting 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 results will be submitted for presentation at a forthcoming medical meeting.
FARXIGA is also being studied in patients with heart failure with preserved ejection fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF) trials.