FDA approves SGLT2 inhibitor for treatment of HFrEF patients
Empagliflozin is now approved by the FDA for treatment of adults with HFrEF to reduce the risk of CV death and hospitalization for HF.
This approval is based on results from the EMPEROR-Reduced phase III trial. Results of the EMPEROR-Reduced showed that empagliflozin reduced the risk of the primary composite endpoint of time to CV death or hospitalization for HF by 25% when compared to placebo, in 3730 patients with HFrEF with and without T2DM. These findings were observed regardless of background HF standard of care treatments. Key secondary endpoint in EMPEROR-Reduced, first and recurrent hospitalization for HF, was reduced by 30% in patients receiving empagliflozin compared to those receiving placebo. Safety profile was consistent with that previously observed.