Consistent Effects of FARXIGA in Heart Failure Patients With Reduced Ejection Fraction Shown in New Analyses From Landmark Phase III DAPA-HF Trial
AstraZeneca today announced new data from five additional analyses of the landmark Phase III DAPA-HF trial, which showed that FARXIGA (dapagliflozin) reduced the risk of the primary composite outcome of worsening heart failure (HF), defined as hospitalization or an urgent visit, or death from cardiovascular (CV) causes versus placebo, when added to standard of care.
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of HF in patients with reduced ejection fraction (HFrEF), with and without type 2 diabetes (T2D). The new analyses showed the consistency of these results across patient subgroups with and without T2D, an early onset of effects, and improvement in patient-reported outcomes of HF-related health status.
These data were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia.
Elisabeth Björk, Senior Vice President, Head of Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, said: “Heart failure affects approximately 64 million people around the world and about half of those patients will die within five years of diagnosis. These new analyses from the DAPA-HF trial reinforce the science behind FARXIGA as clinically significant across heart failure patient populations and suggest the potential to improve the current standard of care for millions of these patients.”
Across all five analyses, FARXIGA showed improvements versus placebo in the worsening or progression of the disease and improved patient-reported symptoms and quality of life.
The Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure Trial (DAPA-HF): Results in Nondiabetic Patients subgroup analysis showed that FARXIGA reduced the risk of the primary composite endpoint compared to placebo in patients with HFrEF without T2D. This analysis evaluated the primary composite and its components and secondary endpoints in a subgroup of patients without T2D. With FARXIGA, the relative risk of the composite of worsening of HF or CV death was reduced by 27% among participants without diabetes (absolute risks 9.2% vs 12.7%, n=2605; HR 0.73 [95% CI 0.60, 0.88]) and by 25% in patients with diabetes (14.6% vs 19.4%, n=2139; HR 0.75 [95% CI 0.63, 0.90]). All components contributed to the overall result. The data suggest that FARXIGA has the potential to be a treatment for patients with HFrEF both with and without T2D.