AstraZeneca recently released results from two key studies at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain, validating the clinical value and differentiation of FARXIGA in treating patients living with heart failure (HF).
Key highlights:
- AstraZeneca has shared its FARXIGA full results from the DELIVER Phase III trial and results of a pre-specified pooled analysis of DAPA-HF and DELIVER.
- In the DELIVER Phase III trial: FARXIGA reduced cardiovascular death or worsening heart failure in patients with heart failure and mildly reduced or preserved ejection fraction (EF) by 18 percent, compared to placebo.
- In the pooled analysis: Phase III DAPA-HF and DELIVER trials demonstrate that in patients with heart failure, FARXIGA reduced the risk of cardiovascular death by 14 percent and reduced death from any cause by 10 percent, irrespective of ejection fraction.
- The results show that FARXIGA can be used as a foundational therapy in all eligible patients with heart failure, regardless of EF.
The heart of the problem
HF is a chronic, long-term condition that worsens over time. It affects nearly 64 million people globally and is associated with substantial morbidity and mortality. It is estimated that half of patients with HF will die within five years of diagnosis. Approximately half of all HF patients have HFmrEF or HFpEF with few therapeutic options available.
Additionally, with limited innovation in the past two decades, there is a significant unmet medical need for new and improved treatment options. Many of these people who live with HF are undertreated and with limited treatment options and could potentially benefit from the cardiorenal protection of FARXIGA, following the results from AstraZeneca.
Full results
The DELIVER full results show FARXIGA (dapagliflozin) significantly reduced cardiovascular (CV) death or worsening heart failure (HF) in patients with HF and mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF) by 18% compared to placebo and were consistent across a broad range of patients.
This is important because it extends the benefits of FARXIGA to the full spectrum of patients with HF irrespective of left ventricle ejection fraction (LVEF) status.
The results show that FARXIGA can be used as a foundational therapy in all eligible patients with heart failure.
Pooled analysis data
In the pooled analysis of DAPA-HF and DELIVER – inclusive of over 11,000 patients – FARXIGA demonstrated a reduction in CV death by 14% and a reduction in death from any cause (ACM) by 10% in HF patients irrespective of ejection fraction.
This is important because FARXIGA is the first HF treatment to demonstrate mortality benefit across the full EF range and there was no reduction in the effect of FARXIGA on patients regardless of EF.
This is the first analysis to demonstrate a mortality benefit with a heart failure medication in patients across the left ventricular ejection fraction range.
A worldwide benefit
The findings add to the clinical evidence showing FARXIGA benefits millions of patients worldwide with HF and provides an option for physicians to treat across the range of LVEF without having to wait for results on LVEF status for their patients.
“Heart failure patients with LVEF greater than 40% are the most difficult to treat with few treatment options available to them. We are proud to share the groundbreaking DELIVER results, which have expanded our understanding of the complexities of HF. These data build upon our previous studies demonstrating cardiorenal protection of FARXIGA across patients with type-2 diabetes, chronic kidney disease and heart failure” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.
Pool of support
The DELIVER data was featured in 11 simultaneous data publications in prestigious journals and this is an extraordinary testament to the scientific rigor and innovation behind the DELIVER and DAPA-HF trial data.
The unprecedented number of publications not only add to the pool of scientific knowledge, but they also reinforce the latest guidance to care teams treating heart failure patients.
The updated 2022 joint HF guidelines issued by the American College of Cardiology, the American Heart Association, and the Heart Failure Society of America, now recommend sodium-glucose cotransporter 2 (SGLT2) inhibitors for HF with mildly reduced EF (HFmrEF) and HF with preserved EF (HFpEF). This expands upon previous recommendations supporting the use of SGLT2 inhibitors in HF with reduced EF (HFrEF). The DELIVER Phase III trial results reinforce this recommendation and may provide further guidance for their broader use in clinical practice.
AstraZeneca strives to develop and deliver innovative, life-changing medicines and solutions for the millions of people affected by the complex spectrum of Cardiovascular, Renal and Metabolic (CVRM) diseases. With a speciality in treatment of CVRM, AstraZeneca positions itself to build a healthier future for people living with CVRM diseases by working collaboratively with physicians, patients, and advocacy organisations to develop patient care.
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