EMPEROR-Preserved phase III trial of Jardiance shows efficacy in heart failure – Eli Lilly + Boehringer

Jardiance (empagliflozin), from Eli Lilly and Boehringer, reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved phase III trial. In EMPEROR-Preserved, two thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50%) and one third had mildly reduced LVEF (greater than 40% but less than 50%).

As previously reported, EMPEROR-Preserved showed that Jardiance significantly reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF over 40% compared with placebo. Jardiance also significantly reduced the risk of first and recurrent hospitalizations for heart failure and slowed kidney function decline. Over half (53.5%) of adults in EMPEROR-Preserved had chronic kidney disease (defined as eGFR below 60 mL/min/1.73 m2 or UACR above 300 mg/g) at trial entry, and 9.7% had severe kidney impairment (eGFR below 30 mL/min/1.73 m2).

The new prespecified sub-analysis of EMPEROR-Preserved demonstrated that the benefits seen in the overall population were consistent in adults with and without chronic kidney disease. Jardiance consistently improved cardiovascular outcomes and slowed kidney function decline across the full range of kidney function down to an eGFR of 20 mL/min/1.73 m2. Jardiance was well tolerated regardless of the level of baseline kidney function. The results were presented at the American Society of Nephrology Kidney Week 2021.