In May 2022, SGLT-2 inhibitors were awarded a Class 2a recommendation for treatment of HFrEF and HFpEF in the most recent publication of heart failure treatment guidelines from the American College of Cardiology/American Heart Association/Heart Failure Society of America.
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Dapagliflozin Now Poised to Treat HF Across Full Spectrum of Disease: DELIVER Phase 3 Top Line Findings
High-level results show the trial met its composite primary endpoint, lowering risk of CV death or worsening disease in patients with HFmrEF/HFpEF.
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Dapagliflozin (Farxiga, AstraZenca), a sodium-glucose cotransporter 2 (SGLT2) inhibitor met its primary endpoint in the DELIVER phase III trial with high-level results showing statistically significant reduction in the study’s primary composite endpoint of cardiovascular (CV) death or worsening heart failure (HF) in patients with HF with mildly reduced or preserved ejection fraction (EF), according to a statement from AstraZeneca, released today.
HF with mildly reduced EF, or HFmrEF, is LVEF 41-49% and HF with preserved EF, or HFpEF, is LVEF ≥50%.
DELIVER principal investigator Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, in the AZ statement expressed the research team’s gratification to have met the primary endpoint in a vulnerable patient population with limited options for treatment. DELIVER, he added, “is the largest and broadest trial to date in heart failure with mildly reduced or preserved ejection fraction” and that the new "results extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.”
Dapagliflozin was approved by the US Food and Drug Administration in May 2020 for the treatment of HF with reduced ejection fraction (HFrEF; LVEF ≤40%) in patients regardless of diabetes status.
DELIVER, launched in August 2018, was a phase 3 international, double-blind, randomized, placebo-controlled trial and randomized 6263 patients with HFmrEF and HFpEF.
The study’s composite primary endpoint was time to first occurrence of CV death, hospitalization for HF, or an urgent HF visit; multiple secondary endpoints included total number of HF events and CV death, change from baseline in the total symptom score of Kansas City Cardiomyopathy Questionnaire at 8 months, time to occurrence of CV death and to death from any cause.
The safety and tolerability profile of dapagliflozin observed in the DELIVER trial, according to the AZ statement, was consistent with the established safety profile of the agent observed in previous trials.
The company said it will submit full trial results for presentation at an upcoming medical meeting and that regulatory submissions will be made in the coming months.
“These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure,” commented Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AstraZeneca.
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