FDA approves empagliflozin for treatment of HFrEF in patients with or without diabetes
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Boehringer Ingelheim and Eli Lilly announced the FDA has approved empagliflozin to reduce risk for CV death and HF hospitalization in adults with HF with reduced ejection fraction regardless of whether they have diabetes.
According to a press release from the companies, the approval of the new indication for the SGLT2 inhibitor empagliflozin (Jardiance) was based on the results of the EMPEROR-Reduced trial, in which, as Healio previously reported, treatment with empagliflozin in addition to recommended therapy reduced the primary composite endpoint of CV death or HF hospitalization by 25% (P < .001), reduced total HF hospitalizations by 30% (P < .001) and reduced renal events by 50% (P < .001) compared with placebo in patients with HFrEF regardless of whether they had diabetes.
In addition, in EMPEROR-Reduced, the empagliflozin group had an RR reduction of 30% for first and recurrent HF hospitalization compared with the placebo group.
“Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical,” Cardiology Today Editorial Board Member Javed Butler, MD, MPH, MBA, chairman of the department of medicine at the University of Mississippi, said in the release. “Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction.”
Empagliflozin was previously approved to lower blood glucose along with diet and exercise in adults with type 2 diabetes and to reduce risk for CV death in adults with type 2 diabetes and known CVD.
Empagliflozin is the second SGLT2 inhibitor to be approved by the FDA for treatment of HFrEF regardless of diabetes status, following dapagliflozin (Farxiga, AstraZeneca).
Empagliflozin was also tested on patients with HF with preserved ejection fraction, with or without diabetes, in the EMPEROR-Preserved trial. Boehringer Ingelheim and Eli Lilly previously announced that top-line results were positive, and the full results will be presented at the European Society of Cardiology Congress next week.
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