DELIVER topline results: Dapagliflozin reduces CV death, worsening HF in EF more than 40%
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Topline findings from the phase 3 DELIVER trial show dapagliflozin significantly reduced risk for CV death or worsening HF compared with placebo in adults HF with mildly reduced or preserved ejection fraction, AstraZeneca announced.
The trial of the SGLT2 inhibitor dapagliflozin (Farxiga) was conducted in more than 6,000 patients with HF with mildly reduced or preserved EF, defined as left ventricular EF greater than 40%. Approximately half of all patients with HF have mildly reduced or preserved EF, with few therapeutic options available.
“We are delighted to have met the primary endpoint in this patient population which has few treatment options,” Scott D. Solomon, MD, professor of medicine at Harvard Medical School, senior physician and director of noninvasive cardiology at Brigham and Women’s Hospital and a principal investigator of the DELIVER trial, said in the release. “DELIVER is the largest and broadest trial to date in HF with mildly reduced or preserved EF. The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.”
The topline results make dapagliflozin the second SGLT2 inhibitor to be proven to improve clinical outcomes in patients with HFpEF. As Healio previously reported, data from EMPEROR-Preserved showed empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) reduced risk for CV death or hospitalization for HF in adults with HFpEF with or without diabetes. The FDA in February expanded empagliflozin’s indication for reduction of CV death and HF hospitalization to include patients with HFpEF.
“Today’s groundbreaking results coupled with those from the DAPA-HF trial show that Farxiga is effective in treating HF regardless of EF,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said in the release. “These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure.”
The safety and tolerability profile of dapagliflozin were consistent with the drug’s safety profile.
The full DELIVER trial results will be submitted for presentation at a forthcoming medical meeting and the company will make regulatory submissions based on the data, according to the release.
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