SGLT2i approved by FDA for treatment of HF regardless of LVEF
The US Food and Drug Administration (FDA) has approved the SGLT2 inhibitor empagliflozin for the treatment of adults with heart failure to reduce the risk of CV death and hospitalization for HF.
In August 2021, empaglifozin had been approved by the FDA to reduce the risk of CV death and HF hospitalization for adult with HF with reduced left ventricular ejection fraction (HFrEF). Now, the new decision of the FDA expands the indication to include all adults with HF.
The approval is based on results from the EMPEROR-Preserved phase III trial. In this trial, the effect of empagliflozin compared with placebo was examined in 5998 adults with HF with LVEF>40%. Empagliflozin reduced the risk of the composite primary endpoint of CV death or HF hospitalization by 21% (HR 0.79, 95%CI:0.69-0.90). In addition, the risk of first and recurrent HF hospitalization was reduced by 27% in those who received empagliflozin (HR 0.73, 95%CI: 0.61-0.88).
“Today’s approval means these demonstrated benefits can now help to address a significant unmet need for adults with preserved ejection fraction, a form of heart failure that has very limited treatment options,” said Javed Butler, MD, Department of Medicine, University of Mississippi, Jackson, MS, USA.