UK-based pharmaceutical and biopharmaceutical company AstraZeneca has announced positive results from the Phase III Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial of its Farxiga (dapagliflozin).

The pharmaceutical company said that the trial has reached the primary endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure, when compared to placebo.

AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos 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.”

DAPA-HF study is designed to evaluate the effect of Farxiga, compared with placebo

AstraZeneca has conducted the DAPA-HF, an international, multi-centre, parallel group, randomised, double-blind trial in patients with heart failure and reduced ejection fraction (HFrEF).

DAPA-HF marks the first trial on heart failure outcomes with an SGLT2 inhibitor investigating the treatment of heart failure in adults with HFrEF on top of standard of care in a representative patient population with and without type-2 diabetes.

The standard of care includes angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers, mineralocorticoid-receptor antagonists and neprilysin inhibitors.

In addition to the standard of care, Farxiga is given once daily, and the time taken for worsening heart failure event or cardiovascular death is set as the primary composite outcome.

AstraZeneca said that Farxiga is an oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction.

In addition, Farxiga has a been subjected to several clinical trials including more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients.

John McMurray from University of Glasgow Cardiovascular Research Centre 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.”