FDA approves Jardiance to treat adults with heart failure regardless of left ventricular ejection fraction.
The FDA has approved Jardiance (empagliflozin) 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim and Eli Lilly and Company announced.
Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
This approval is based on results from the landmark EMPEROR-Preserved phase III trial, which investigated the effect of Jardiance 10 mg compared with placebo once daily, both on top of standard of care therapy, in 5,988 adults with heart failure with LVEF over 40%. In the trial, Jardiance demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. In both EMPEROR-Preserved and EMPEROR-Reduced, the benefit was generally consistent across LVEF subgroups.
A key secondary endpoint analysis from EMPEROR-Preserved showed that Jardiance reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% (407/2997 events for Jardiance vs. 541/2991 for placebo, 0.73 HR, 0.61-0.88 95% CI.)
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