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The phase 3 DELIVER trial has met its primary endpoint, with use of dapagliflozin (Farxiga) associated with a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in patients with heart failure with mildly reduced or preserved ejection fraction, according to a release from AstraZeneca.
Announced on May 5, results of the trial provide evidence of dapagliflozin’s efficacy in heart failure across the spectrum of ejection fraction and come just over a month after the release of the ACC/AHA/HFSA 2022 heart failure guidelines, which awarded a Class 2a recommendation for SGLT2 inhibitors in heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF).
“We are delighted to have met the primary endpoint in this patient population which has few treatment options. DELIVER is the largest and broadest trial to date in heart failure with mildly reduced or preserved ejection fraction. The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital and principal investigator of the DELIVER trial.
An international, double-blind, randomized, placebo-controlled trial launched in August 2018, DELIVER randomized 6263 with either heart failure with mildly reduced ejection fraction (HFmrEF) and preserved EF (HFpEF), which were defined as ejection fractions of 41-49% and 50% or greater, respectively. Event-driven in design, the trial had a primary endpoint of time to first occurrence of cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit and multiple secondary endpoints, including total number of heart failure events and cardiovascular death, change from baseline in the total symptom score of the KCCQ at 8 months, time to the occurrence of cardiovascular death, and time to the occurrence of death from any cause.
In their release, AstraZeneca pointed out the safety and tolerability profile of dapagliflozin observed in the DELIVER trial was consistent with the established safety profile observed in previous trials. Additionally, AstraZeneca noted plans to submit full trial results for presentation at an upcoming medical meeting and regulatory submissions will be made within the next month.
"Today’s groundbreaking results coupled with those from the DAPA-HF trial show that Farxiga is effective in treating heart failure regardless of ejection fraction. These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.