DELIVER Trial Scores a Win for Dapagliflozin in HFpEF

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) met its primary endpoint in the DELIVER phase III trial by significantly lowering the risk of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction (HFpEF), the drugmaker AstraZeneca announced today.

In February, based on results of the EMPEROR-Preserved randomized trial, another SGLT2 inhibitor, empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly), became the first of these drugs to receive an expanded indication for treatment of HFpEF patients—a group for whom few therapies have proved effective. Dapagliflozin is not yet approved for the treatment of patients with HFpEF, although it has been cleared for patients with diabetes and for heart failure patients with reduced EF. It’s also approved for adults with chronic kidney disease at risk of progression, to reduce the risk of worsening kidney disease, cardiovascular death, and hospitalization for heart failure.

In a press release, Scott Solomon, MD (Harvard Medical School and Brigham and Women’s Hospital, Boston, MA), the principal investigator of the DELIVER trial, said the new results “extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.” The drug is already approved for the treatment of heart failure with reduced ejection fraction (HFrEF), as well as diabetes and chronic kidney disease.

According to AstraZeneca, the full study results will be submitted for presentation at a forthcoming medical meeting and regulatory submissions will be made in the coming months.