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By Kristin J. Kelley
Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The FDA has approved the diabetes drug dapagliflozin (marketed as Farxiga) to reduce the risk for heart failure hospitalization in adults with type 2 diabetes plus established cardiovascular disease or cardiovascular risk factors.
The sodium-glucose cotransporter 2 (SGLT2) inhibitor is the first in its class to be approved for this use, according to the manufacturer.
Dapagliflozin was first approved to treat type 2 diabetes in 2014. Approval for the new use was based on results from the DECLARE-TIMI 58 trial, in which patients with diabetes and high cardiovascular risk who received the drug had a lower rate of heart failure hospitalization or cardiovascular death than those on placebo.
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LINK(S):
Manufacturer's news release (Free)
Reuters story (Free)
Background: NEJM Journal Watch Cardiology coverage of DECLARE-TIMI 58 (Your NEJM Journal Watch registration required)