Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance® (empagliflozin) following stabilization and prior to discharge compared with placebo in the phase III EMPULSE trial, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. Clinical benefit reflected a composite primary endpoint that included all-cause mortality, frequency of heart failure events, time to first heart failure event and symptoms as measured by the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS). The findings were published in Nature Medicine and presented at the American Heart Association’s Late-Breaking Scientific Sessions 2021.
“The first months following hospitalization for heart failure are a particularly vulnerable time for patients,” said Adriaan Voors, Professor of Cardiology, University Medical Center, Groningen, Netherlands, and EMPULSE principal investigator. “Current outcomes are poor, underscoring the urgent need for improved in-patient clinical management to prevent further hospitalizations or death. This significant clinical benefit with empagliflozin compared with placebo will advance our understanding of the treatment of heart failure during the early discharge phase.”
Heart failure is a leading cause of hospitalizations, accounting for more than 1 million per year in the U.S. Outcomes for those who have been admitted to the hospital for heart failure are poor, with over 30% of patients readmitted within 90 days between 2010 and 2017, according to the National Readmission Database.
The overall clinical benefit with Jardiance was consistent for those with either new or pre-existing heart failure, for those with or without diabetes and for those with either preserved or reduced ejection fraction. In an exploratory secondary endpoint, Jardiance significantly improved KCCQ-TSS from baseline to day 90 by 4.5 points versus placebo.
The EMPULSE safety results were consistent with the well-established safety profile of Jardiance. Investigator-reported acute renal failure rates were 7.7% for Jardiance versus 12.1% for placebo, and there was a similar low incidence of hypoglycemia in both groups (1.9% for Jardiance vs. 1.5% for placebo). Volume depletion rates were 12.7% versus 10.2%, respectively.
“We are encouraged by the early and significant clinical benefit seen in EMPULSE with Jardiance when initiated in adults with heart failure with either preserved or reduced ejection fraction prior to hospital discharge, including improvements in an endpoint combining mortality, hospitalizations and quality of life,” 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. “We remain committed to trials such as this that help us better understand how this therapy may benefit people with a range of cardio-renal-metabolic conditions for whom additional treatment options are greatly needed.”
“The EMPULSE results add to the growing weight of evidence from our EMPOWER program supporting the potential role of Jardiance in a range of conditions affecting the heart, kidneys and metabolic system,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “The clinical benefit and consistent safety results demonstrated in the vulnerable phase following hospital discharge suggest that in-hospital initiation with Jardiance for appropriate patients can improve outcomes during these critical months.”
Recently, the U.S. Food and Drug Administration (FDA) approved Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure based on data from the EMPEROR-Preserved® trial. This decision marks the third U.S. FDA approval for Jardiance stemming from the EMPOWER program.