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DAPA-HF results demonstrate diabetes drug reduces worsening of heart failure
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AstraZeneca today announced positive top-line results for its landmark phase 3 DAPA-HF trial, noting that the SGLT2 inhibitor dapagliflozin met the primary composite endpoint of reduction of cardiovascular death or the worsening of heart failure compared with placebo in participants with and without diabetes, according to a company press release.
DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in adults with reduced ejection fraction in addition to standard of care in patients with and without type 2 diabetes. The safety profile for dapagliflozin (Farxiga) in DAPA-HF was consistent with previous trials with the drug, according to the release.
“With the DAPA-HF trial, Farxiga 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,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in the release. “Today, half of heart failure patients will die within 5 years of diagnosis, and it remains one of the leading causes of hospitalization. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible.”
Since dapagliflozin was first approved by the FDA in 2014 for the treatment of type 2 diabetes in adults, several studies have demonstrated the potential for SGLT2 inhibitors as a class in the prevention and treatment of HF. As Healio News previously reported, the overall findings from the DECLARE-TIMI 58 CV outcome trial showed that dapagliflozin 10 mg reduced the composite endpoint of CV death and heart failure hospitalization over 4 years — mainly driven by the reduction in heart failure hospitalization — in a broad population of patients with type 2 diabetes. In a prespecified subanalysis presented in March at the American College of Cardiology Scientific Sessions, researchers reported that treatment with dapagliflozin reduced heart failure hospitalizations in patients with a broad range of left ventricular ejection fraction and may provide even greater benefit with lower CV death and mortality in patients with heart failure with reduced ejection fraction.
Dapagliflozin does not have an FDA indication to reduce the risk for heart failure or CV death. Dapagliflozin is also being studied in patients with heart failure with preserved ejection fraction in the DELIVER and DETERMINE trials.
The full DAPA-HF trial results will be presented at a forthcoming medical meeting, according to the release. — by Regina Schaffer
Disclosures: Pangalos is executive vice president of biopharmaceuticals research and development for AstraZeneca.