Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.
The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved by FDA in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.
"The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure," principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women's Hospital, Boston, said in the news release.
The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.
The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.
www red DiabetologNytt