August 18, 2021

Jardiance® (empagliflozin) 10mg, manufactured by Boehringer Ingelheim and Eli Lilly, is now U.S. FDA approved to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults who have heart failure with reduced ejection fraction (HFrEF). The new indication is the third for Jardiance, which is also approved to reduce the risk of cardiovascular death in adults who have type 2 diabetes mellitus and established cardiovascular disease, and as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus.

In HFrEF, the left ventricle of the heart can’t contract as well as it should and has trouble circulating blood throughout the body. More than half of all patients who have heart failure have HFrEF.

In a clinical trial, adding Jardiance 10mg to standard of care reduced the relative risk of first and recurrent hospitalization for heart failure by 30% compared to placebo plus standard of care. It also reduced the relative risk of time to cardiovascular death or hospitalization for heart failure by 25%.

Recommended dosing under the new indication is one 10mg tablet taken by mouth with or without food once each morning. For patients who have type 2 diabetes and need additional glycemic control, the dose can be increased to 25mg a day if tolerated. Jardiance should not be used by patients who have type 1 diabetes due to risk of diabetic ketoacidosis and should not be used for glycemic control in certain patients who have impaired kidney function.

Jardiance first received FDA approval in 2014.

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