FDA okays dapagliflozin for heart failure with reduced ejection fraction
medwireNews: The FDA has approved the use of dapagliflozin for patients who have heart failure with reduced ejection fraction, regardless of whether they have type 2 diabetes.
The findings follow the publication last year of the DAPA-HF trial, which recruited a study population that included 55% without diabetes. It makes dapagliflozin the first sodium-glucose cotransporter-2 inhibitor to be approved for this indication.
Over a median follow-up of 18.2 months, the 2373 DAPA-HF participants treated with dapagliflozin had a significant 26% reduced risk for the primary composite outcome of cardiovascular death, heart failure hospitalization, or an urgent heart failure hospital visit relative to the 2371 participants given placebo.
A more recent stratified analysis showed benefits in people both with and without diabetes, while other analyses confirmed benefit regardless of age and showed significant quality of life gains for the participants given dapagliflozin. The DEFINE-HF findings also added weight to the efficacy of dapagliflozin in this population.
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