New sub-analysis of the EMPEROR-Reduced phase III trial of Jardiance showed improved cardio-renal outcomes in adults with heart failure with reduced ejection fraction regardless of chronic kidney disease status.- Boehringer + Eli Lilly

Findings from a new exploratory sub-analysis of the EMPEROR-Reduced phase III trial showed that Jardiance (empagliflozin) reduced the risk of adverse cardiovascular and kidney events in adults with heart failure with reduced ejection fraction – with and without diabetes – regardless of chronic kidney disease status at baseline . These results were shared as an oral presentation at the American Society of Nephrology Kidney Week 2020 and published in Circulation. "On their own, heart failure and chronic kidney disease are each associated with an increased risk of hospitalizations and premature death from cardiovascular causes. The presence of one condition often accelerates the onset and progression of the other, further increasing this risk and leading to poorer prognoses," said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. "In EMPEROR-Reduced, empagliflozin demonstrated a consistent reduction in the risk of the composite primary endpoint of cardiovascular death and heart failure hospitalizations, while slowing kidney function decline, in adults with heart failure with reduced ejection fraction, with and without chronic kidney disease. This is promising news for the growing population of adults suffering from both heart failure and chronic kidney disease." As previously reported, EMPEROR-Reduced showed Jardiance reduced the relative risk of the combined endpoint of cardiovascular death or hospitalization for heart failure by 25% and of first and recurrent hospitalizations for heart failure by 30%, and slowed the decline in eGFR, a measure of kidney function, in adults with heart failure with reduced ejection fraction with and without diabetes. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint, including end stage kidney disease and a profound loss of kidney function, by 50%. In this new analysis of all endpoints, these benefits were consistently observed in subgroups of patients with and without chronic kidney disease at baseline, including patients with severe renal impairment. In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was similar to the well-established safety profile of Jardiance. In March 2020, the FDA)granted Fast Track designation to Jardiance for the treatment of chronic kidney disease, demonstrating the urgent need for new treatment options for people living with the condition. This designation covers the ongoing EMPA-KIDNEY trial, which is investigating the effect of Jardiance on the progression of kidney disease and occurrence of cardiovascular death in adults with established chronic kidney disease, with and without diabetes. Results from EMPA-KIDNEY are expected in 2022.