According to the data, Farxiga continues to provide clinically significant advantages to patients with heart failure regardless of their ejection fraction
The AstraZeneca R&D facility in Gothenburg, Sweden. (Credit: Erik031/Wikipedia)
AstraZeneca has announced the results of the DELIVER Phase III trial that showed its Farxiga (dapagliflozin) reduced the risk of cardiovascular (CV) death or worsening heart failure.
Presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain, it was conducted on patients with HF and mildly reduced or preserved ejection fraction (EF), compared to a placebo.
Over a median follow-up of 2.3 years, farxiga decreased 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).
AstraZeneca said the success of the primary endpoint was enhanced by each individual component.
The results extended the advantages of Farxiga across the whole range of patients with HF regardless of left ventricular ejection fraction (LVEF) status and were consistent across subgroups.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score, a patient-reported outcome measure, revealed a symptom benefit in the study results as well.
In comparison to previous studies in this patient population, DELIVER was developed with expanded inclusion criteria to also include patients who were/ are hospitalised or those with HF and improved LVEF, for whom evidence-based therapy is limited.
Farxiga’s safety and tolerability profile in the DELIVER Phase III trial was in line with the drug’s well-known safety profile.
The firm also announced the pre-specified pooled analysis from Phase III trials.
It demonstrated a reduction in CV death by 14% and a reduction in death from any cause by 10% in patients with heart failure irrespective of ejection fraction.
The results from a pre-specified, patient-level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated the mortality benefit of Farxiga, compared to placebo, in patients with heart failure.
This is the first investigation to show a mortality benefit with an HF drug in patients with HF across the left ventricular ejection fraction (LVEF) range.
According to the analysis, Farxiga reduced the risk of CV death by 14% over the median follow-up of 22 months and death from any cause by 10%.
Additionally, the total hospitalisation rate was reduced by 29%, and the composite of death from CV causes, myocardial infarction, or stroke by 10%, in patients with HF irrespective of LVEF.