AstraZeneca’s DELIVER Phase III trial reveals heart failure results

Published: 24-May-2023

Presented at European Society of Cardiology’s Heart Failure 2023 congress, the trials supported the consistent benefits of Farxiga regardless of heart failure (HF) duration

Two new analyses from the DELIVER Phase III trial presented at European Society of Cardiology’s Heart Failure 2023 congress in Prague, Czech Republic supported the consistent benefits of Farxiga regardless of heart failure (HF) duration and across the spectrum of cardiovascular, renal and metabolic (CVRM) conditions.

Prespecified analysis of the DELIVER Phase III trial examined the treatment effect of Farxiga in patients with left ventricular ejection fraction (LVEF) greater than 40% based on how long they have had HF: ≤6 months, >6-12 months, >1-2 years, >2-5 years and >5 years. 

Results showed the benefit of Farxiga was consistent across all categories, regardless of HF duration. Furthermore, the absolute benefit was increased in longer-standing HF patients who were older, had one or more comorbidity and had higher rates of worsening HF and death (number needed to treat, NNT: 24 vs 32 for patients with HF duration >5 years and ≤6 months duration respectively).

Additional post hoc analysis from the DELIVER Phase III trial was also presented and simultaneously published in JACC Heart Failure, evaluating the prevalence of overlapping CVRM conditions and participants’ response to Farxiga at each intersection. 

The results showed that more than 4 in 5 patients with HF and LVEF greater than 40% had at least one other concomitant CVRM condition, and 1 in 5 had three CVRM conditions in addition to HF. Farxiga was well-tolerated and its treatment benefits were consistent irrespective of CVRM condition.

Dr Scott Solomon, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital and Principal Investigator of the DELIVER Phase III trial, said: “In current clinical practice, patients with long-standing heart failure may be seen as having advanced disease that will not respond to or tolerate the addition of new therapies.”

Solomon continued: “Still, data from the DELIVER Phase III trial show it is never too late for patients to benefit from treatment with an SGLT2 inhibitor such as dapagliflozin, which maintained consistent benefits across different heart failure durations. This data contributes to the growing body of evidence on the efficacy of dapagliflozin in heart failure, demonstrating that it can help long-standing patients as much as someone who is newly diagnosed.”

The impact of CVRM diseases on both patients and wider society are immense

Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The impact of CVRM diseases on both patients and wider society are immense, yet these patients remain underdiagnosed, undertreated and their interconnections under-recognised.

Findings from the DELIVER Phase III trial highlight how common it is for heart failure patients to have other CVRM conditions, such as type-2 diabetes and chronic kidney disease. These analyses further demonstrate the value of Farxiga as it brings benefit across all cardiorenal conditions and underscores our commitment to fundamentally transform care for millions of patients with heart failure and other CVRM conditions.”

HF is a chronic, long-term condition that worsens over time and approximately half of HF patients die within five years of diagnosis. It is often complicated by interconnected CVRM conditions, making it even more difficult to manage. Up to one in five people with chronic kidney disease (CKD) will develop HF, the leading cardiovascular (CV) complication among this group of patients.

These findings build upon the previously reported results from the DELIVER and DAPA-HF Phase III trials, which provide evidence to support the use of Farxiga as foundational therapy for patients with HF, and confirms Farxiga as the only heart failure medication to demonstrate mortality benefit regardless of ejection fraction (EF).

The safety and tolerability profile of Farxiga in the DELIVER Phase III trial was consistent with the well-established safety profile of the medicine.

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