FDA Approves Dapagliflozin (Farxiga) for Heart Failure with Reduced Ejection Fraction
The sodium-glucose co-transporter 2 (SGLT2) inhibitor, dapagliflozin (Farxiga), is the first drug in its class that has shown to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction (HFrEF).
In the DAPA HF trial, treatment with dapagliflozin led to a reduction in risk of a primary endpoint consisting primarily of cardiovascular death or heart-failure hospitalization in patients with HFrEF, in both those with and without diabetes. The randomized, placebo-controlled trial had more than 4700 patients.
Traditionally viewed only as an antidiabetic agent, dapagliflozin has long been indicated for improvement of glycemic control in adults with type 2 diabetes. The latest approval for patients with HFrEF makes dapagliflozin the only SGLT2 inhibitor to be indicated for heart failure in the absence of diabetes.
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