RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 23, 2020 /PRNewswire/ — 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 today as an oral presentation at the American Society of Nephrology Kidney Week 2020 and published in Circulation, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
“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.
“Over half of people with heart failure have moderate to severe chronic kidney disease, yet, there remains a need for new treatment options that address these interconnected conditions,” said Mohamed Eid, M.D., M.P.H, M.H.A, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “These findings continue to show the potential of Jardiance to help improve the lives of adults living with cardio-renal-metabolic conditions, including heart failure and chronic kidney disease.”
“Heart failure and chronic kidney disease are common, life-threatening diseases that require improved treatment options. The EMPOWER clinical development program, including our ongoing EMPEROR-Preserved and EMPA-KIDNEY trials, explores the potential role Jardiance may play in improving outcomes for people with these conditions,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “The new findings from EMPEROR-Reduced will help us achieve our goal of redefining how people living with these conditions are treated.”
In March 2020, the U.S. Food and Drug Administration (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.
The FDA also granted Fast Track designation in June 2019 to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options. EMPEROR-Preserved results are expected in 2021. Jardiance is not indicated for the treatment of heart failure.
The EMPEROR and EMPA-KIDNEY studies are part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.
*Composite exploratory endpoint included chronic dialysis or renal transplant or sustained reduction of ?40% in eGFR (CKD-EPI) or a sustained eGFR <15 mL/min/1.73 m2 (for patients with baseline eGFR ?30) or sustained eGFR <10 mL/min/1.73 m2 (for patients with baseline eGFR <30 mL/min/1.73 m2).