AstraZeneca on Wednesday announced that its dapagliflozin has significantly reduced the risk of cardiovascular death and heart failure, as per the outcomes of the DELIVER Phase III trial. DELIVER which stands for Dapagliflozin Evaluation to Improve the LIVES of Patients With PReserved Ejection Fraction Heart Failure, is the largest clinical trial to date in Heart Failure (HF) patients with 6,263 randomised patients.
The outcomes of the trial were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain, and simultaneously published in The New England Journal of Medicine.
“Dapagliflozin 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 dapagliflozin to the full spectrum of patients with HF irrespective of left ventricular ejection fraction (LVEF) status,” the pharma major said in a statement on Wednesday.
Moreover, the trial results also showed a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score.
Meanwhile, the company also stated that 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 dapagliflozin 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), it stated.
“We are committed to push the boundaries of available research and bring the best-in-class solutions for patients. Our ground-breaking results from DELIVER indicate Dapagliflozin’s positive and significant impact on patients with cardiorenal problems. We are constantly enhancing our understanding of the current disease biology with the aim of treating, preventing and even curing complex diseases in near future,” Dr. Anil Kukreja, Vice President – Medical Affairs & Regulatory said in a statement.
The company claims that the safety and tolerability profile of dapagliflozin in the DELIVER Phase III trial was consistent with the well-established safety profile of the medicine.