AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, reported on Tuesday 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.
This trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without type-2 diabetes.
Also, the safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine.
Reportedly, 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.
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.
AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, CVRM and Respiratory.
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