DELIVER is the world’s largest study of heart failure with intact ejection fraction. The DELIVER phase 3 trial produced favourable findings for AstraZeneca. It showed that Farxiga (dapagliflozin) reduced the primary outcome of cardiovascular death or deteriorating heart failure by a statistically relevant and clinically important amount.
Patients with mildly diminished or maintained ejection fraction – defined as a left ventricular ejection fraction of more than 40% – were included in the study. Cardiac arrest is a long-term, chronic illness that becomes worse over time. It interferes with the heart’s pumping activity, causing weariness and breathlessness. The disease affects over 64 million individuals worldwide and is linked to high mortality and morbidity rates.
They are happy to have met the primary outcome in this population of patients with few treatment alternatives, said Dr. Scott Solomon, a Harvard Medical School professor of medicine. DELIVER is the largest and most comprehensive study of modestly decreased or retained ejection fraction in heart failure to date. The findings of DELIVER show that dapagliflozin benefits a wide range of heart failure patients. The pioneering results, together with those from the DAPA-HF trial, reveal that Farxiga is successful in treating heart failure irrespective of ejection fraction, said Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, Mene Pangalos.
These findings add to prior research that showed cardiorenal protection in patients with diabetes, chronic kidney disease, or heart failure.In the coming months, the full results of the DELIVER phase 3 trial will be presented for discussion at a medical meeting, and regulatory submissions will be made.