The US FDA has expanded the indication for empagliflozin to treat heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and hospitalisation for heart failure. The dose for which empagliflozin has received approval is 10-mg once-daily dose. It can be started in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m².

This approval is based on the findings of the EMPEROR-Reduced trial published in the New England Journal of Medicine last year in which empagliflozin was found to reduce the risk of cardiovascular death or hospitalization for heart failure among HFrEF patients with diabetes or without diabetes.

Empagliflozin is a sodium glucose cotransporter-2 inhibitor (SGLT2 inhibitor) and in 2014, it was approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. But it is not indicated for persons with type 1 diabetes or diabetic ketoacidosis. In 2016, following publication of the landmark EMPA-REG OUTCOME trial, empagliflozin was FDA approved to prevent cardiovascular death in adults with type 2 diabetes and heart disease.

Empagliflozin is contraindicated in cases of hypersensitivity to empagliflozin or any of its excipients and also in patients on dialysis.

(Source: Medpage Today August 18, 2021; European Pharmaceutical Review, August 19, 2021)