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AstraZeneca’s Dapagliflozin reduces risk of cardiovascular death in DELIVER Phase III trial

Data extend the clinically meaningful benefits of dapagliflozin in patients with heart failure regardless of ejection fraction

Detailed results from the DELIVER Phase III trial showed AstraZeneca’s 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 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 per cent (p<0.001, 16.4 per cent in the dapagliflozin group and 19.5 per cent 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 trial results also showed a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score. 

Dr VK Chopra, Senior Director, Cardiac Sciences, Cardiology, Max Super Speciality Hospital, Saket and Past President, Heart Failure Association of India said, “HFpEF is an underdiagnosed and undertreated condition with high morbidity and mortality. It is considered an orphan therapy area by clinicians as for the last 50 years, limited therapies have shown any benefit in outcomes. DELIVER results helps us to address this huge unmet need and also add to the evidence that Dapagliflozin is effective in reducing cardiovascular outcomes across the spectrum of heart failure irrespective of ejection fraction.”

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). 

Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory said, “We are committed to pushing the boundaries of available research and bringing 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 to treat, prevent and even cure complex diseases in near future.”

With a concentrated focus and efforts toward the delivery of research and science-based solution, AstraZeneca’s DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of dapagliflozin. It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years of experience. Dapagliflozin is currently being tested in patients without T2D following an acute myocardial infarction or heart attack in the DAPA-MI Phase III trial – a first-of-its-kind, indication-seeking registry-based randomised controlled trial. 

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 dapagliflozin as a foundational therapy for patients with HF, regardless of ejection fraction. 

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

 

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