DELIVER represents the largest ever trial to address heart failure with preserved ejection fraction
AstraZeneca has reported positive results from the DELIVER phase 3 trial. It demonstrated that Farxiga (dapagliflozin) reached a statistically significant and clinically meaningful reduction in the primary endpoint of cardiovascular (CV) death or worsening heart failure.
The trial was conducted in patients with mildly reduced or preserved ejection fraction – defined as left ventricular ejection fraction greater than 40%.
Heart failure is a chronic, long-term condition that worsens over time. It affects the pumping action of the heart muscles, causing fatigue and shortness of breath. The condition affects nearly 64 million people globally, and is associated with substantial morbidity and mortality.
Dr. Scott Solomon, Professor of Medicine at Harvard Medical School, said: “We are delighted to have met the primary endpoint in this patient population which has few treatment options. DELIVER is the largest and broadest trial to date in heart failure with mildly reduced or preserved ejection fraction. The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, added: "Today’s groundbreaking results coupled with those from the DAPA-HF trial show that Farxiga is effective in treating heart failure regardless of ejection fraction.
“These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure.”
The complete results of the DELIVER phase 3 trial will be submitted for presentation at a medical meeting in the near future, and regulatory submissions will be made in the coming months.