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 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."
John McMurray, MD, 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.
About DAPA-HF
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. DAPA-HF is an international, multi-centre, parallel group, randomised, double-blind trial in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without type-2 diabetes, designed to evaluate the effect of Farxiga 10mg, compared with placebo, given once daily in addition to standard of care. The primary composite outcome was time to a worsening heart failure event (hospitalisation or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death.
About heart failure
Heart failure (HF) is a life-threatening disease in which the heart cannot pump enough blood around the body.(1) 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.(2,3,4) HF remains as 'malignant' as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancers).(5) It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.(6)
About Farxiga
Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control,...
(All Rights Reserved)