AstraZeneca announced positive results from the landmark 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 hospitalization or an urgent heart failure visit), compared to placebo.
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is the first heart failure trial with an SGLT2 inhibitor and morbidity and mortality outcomes investigating the treatment of heart failure on top of standard of care, in a representative patient population (NYHA II to IV) with and without type-2 diabetes. The international, parallel group, randomized, double-blind trial was conducted in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without type-2 diabetes. The patients received Farxiga 10mg or placebo, each given once daily in addition to standard of care. The primary composite outcome was time to a worsening heart failure event (hospitalization or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death.
The full DAPA-HF trial results will be submitted for presentation at a forthcoming medical meeting.
About Heart failure
Heart failure (HF) is a life-threatening disease in which the heart cannot pump enough blood around the body. It affects approximately 64 million people worldwide (half of which have a reduced ejection fraction) and is a chronic and degenerative disease where half of patients will die within five years of diagnosis. HF is the leading cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden.
Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D.