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Dapagliflozin significantly reduced the risk of cardiovascular death or worsening heart failure when added to standard of care treatment in patients with reduced ejection fraction (HFrEF), according to findings from the phase 3 DAPA-HF trial.
In the DAPA-HF (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure) study, patients with heart failure and reduced ejection fraction (LVEF ≤40%), with and without type 2 diabetes, were randomized to receive dapagliflozin 10mg or placebo in addition to standard of care. The primary composite outcome was the time to first occurrence of cardiovascular death or hospitalization for heart failure or an urgent heart failure visit.
Results of the trial showed that the primary end point was met; treatment with dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was associated with a statistically significant and clinically meaningful reduction in cardiovascular death or worsening of heart failure, when compared with placebo. In addition, the safety profile of dapagliflozin was found to be consistent with that seen in previous trials. In a press release, AstraZeneca noted that additional data from DAPA-HF will be shared at an upcoming medical meeting.
“With the DAPA-HF trial, [dapagliflozin] becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type 2 diabetes, on top of standard of care,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D. “We look forward to discussing the results of DAPA-HF with health authorities as soon as possible.”
Dapagliflozin (Farxiga) is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
For more information visit astrazeneca-us.com.
