Dapagliflozin significantly reduced the risk of cardiovascular death or worsening of heart failure in patients with heart failure and preserved ejection fraction (HFpEF), according to data from the phase 3 DELIVER trial.
The placebo-controlled, event-driven study (ClinicalTrials.gov Identifier: NCT03619213) included 6263 patients 40 years of age and older with HFpEF (left ventricular ejection fraction [LVEF] >40% and evidence of structural heart disease), with or without type 2 diabetes. Patients were randomly assigned (1:1) to receive dapagliflozin 10mg or placebo once daily, in addition to background therapy.
The primary composite endpoint was the time to first occurrence of CV death, hospitalization for heart failure or an urgent heart failure visit, in the full study population, as well as in patients with LVEF <60%.
Findings showed that the trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in CV death or worsening of heart failure with dapagliflozin when compared with placebo. Results for additional outcome measures such as the total number of heart failure events and CV death, the change from baseline in the total symptom score of the Kansas City Cardiomyopathy Questionnaire at 8 months, the time to the occurrence of CV death, and the time to the occurrence of death from any cause, will be presented at an upcoming medical meeting.
“Today’s groundbreaking results coupled with those from the DAPA-HF trial show that [dapagliflozin] is effective in treating heart failure regardless of ejection fraction,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure.”
Data from the DELIVER trial will be included in regulatory submissions in the coming months. Dapagliflozin is marketed under the brand name Farxiga and is currently approved to reduce risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA Class II-IV) with reduced ejection fraction based on data from the DAPA-HF trial (ClinicalTrials.gov Identifier: NCT03036124).
It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established CV disease or multiple CV risk factors.
In May 2021, the FDA granted approval to Farxiga to reduce the risk of sustained estimated glomerular filtration rate decline, end stage kidney disease, CV death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Farxiga met primary endpoint in DELIVER phase III trial, reducing risk of cardiovascular death or worsening heart failure in patients with preserved ejection fraction. News release. Accessed May 5, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/farxiga-hfpef-phase-iii-trial-met-primary-endpoint.html