AstraZeneca has reported pooled analysis data from the Phase III DAPA-HF and DELIVER clinical trials, where Farxiga (dapagliflozin) showed to reduce cardiovascular mortality risk in heart failure (HF) patients.
The global, multicentre, parallel-group, randomised, double-blinded DAPA-HF trial enrolled 4,744 HFrEF patients irrespective of type-2 diabetes (T2D) status.
It analysed 10mg Farxiga’s impact versus placebo, administered once a day daily along with the standard of care (SoC) that comprised an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).
The global, randomised, double-blind, parallel-group, placebo-controlled, event-driven DELIVER trial analysed the efficacy of Farxiga versus placebo enrolling 6,263 subjects to treat HF with left ventricular ejection fraction (LVEF) greater than 40%, irrespective of T2D status.
Farxiga was administered once a day along with background therapy in this trial.
DAPA-HF enrolled patients with an LVEF of 40% or less DELIVER randomised subjects with an LVEF greater than 40%.
According to the findings, the decline in cardiovascular (CV) mortality risk was in line across pre-specified subgroups.
It is the first assessment to show a mortality benefit with HF treatment in HF patients across various LVEF ranges.
In HF patients irrespective of LVEF status, Farxiga lowered CV death risk by 14% over 22 months of median follow-up.
Additionally, the treatment offered a 10% and 29% reduction in death from any cause and total hospitalisation for HF, respectively, as well as a 10% reduction in the composite of death from CV causes, myocardial infarction or stroke.
Farxiga is an oral inhibitor of sodium-glucose cotransporter 2 (SGLT2).
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Heart failure remains one of the leading causes of death worldwide with high unmet need for some 64 million people.
“This analysis demonstrates Farxiga’s ability to treat patients across the full left ventricular ejection fraction spectrum and reduce the risk of cardiovascular death.”
In May this year, the company dosed the first subject in the Phase III PACIFIC-9 trial of durvalumab plus monalizumab or its oleclumab in unresectable, Stage III non-small cell lung cancer patients.