# AstraZeneca’s Farxiga reduced risk of cardiovascular death in trial

- Link: https://www.directorstalkinterviews.com/astrazenecas-farxiga-reduced-risk-of-cardiovascular-death-in-trial/4121079881
- Published: 2022-08-30T07:14:51+01:00
- Author: Amilia Stone

Detailed results from the DELIVER Phase III trial showed **[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Farxiga_ (dapagliflozin) significantly reduced the composite of cardiovascular (
CV) death or worsening heart failure (HF) in patients with HF and mildly reduced
or preserved ejection fraction (EF), compared to placebo. The results were presented
today at the European Society of Cardiology Congress 2022 in Barcelona, Spain, and
simultaneously published in _The New England Journal of Medicine_^(1).

_Farxiga_ reduced the composite outcome of CV death or worsening of HF by 18% (p
<0.001, 16.4% in the dapagliflozin group and 19.5% in the placebo group over a median
follow-up of 2.3 years). All individual components contributed to the superiority
of the primary endpoint. The findings were consistent across key subgroups examined
and extend the benefits of _Farxiga_ to the full spectrum of patients with HF irrespective
of left ventricular ejection fraction (LVEF) status. The trial results also showed
a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy
Questionnaire (KCCQ) total symptom score^(1).

> **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**: “These results from DELIVER are important for patients and clinical care
> as it shows that dapagliflozin is effective regardless of ejection fraction and
> therefore can be used as foundational therapy in all eligible patients with heart
> failure. Earlier HFpEF trials have shown attenuation in the highest LVEF but with
> dapagliflozin results are consistent across the LVEF range. The findings also 
> reinforce most recent treatment guidelines, recommending earlier initiation of
> guideline-directed medical treatment and may support broader use of SGLT2 inhibitors
> in clinical practice.”

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 such as _Farxiga_ 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)
^(2).

> **Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca,
> said**:
> “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.”

DELIVER was designed with broader inclusion criteria than prior trials in this patient
population to also include patients who were hospitalised, recently hospitalised,
or those with HF with improved LVEF, for whom evidence-based therapy is limited^(
1,2). These findings build upon the previously reported results from DAPA-HF, the
only SGLT2 inhibitor outcomes trial in HF to demonstrate a significant reduction
in mortality, to provide further evidence to support the use of _Farxiga_ as foundational
therapy for patients with HF, regardless of ejection fraction.

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

**References**

_1.   Solomon S, et al. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved
Ejection Fraction. N Engl J Med 2022 [cited 2022 Aug 27] Available from: www.nejm.
org/doi/full/10.1056/NEJMoa2206286_

_2.   Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart
Failure: A report of the American College of Cardiology/American Heart Association
Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(17):
e263-421._

Share on: