EMPULSE Phase III Trial Demonstrates Significant Clinical Benefits of Empagliflozin in Adults with Acute Heart Failure Following Hospitalization

Ingelheim, Germany and Indianapolis, USA, 2022March 16Japan /PR Newswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) recently announced that in the Phase III EMPULSE trial, adult patients hospitalized for acute heart failure who were stabilized and administered empagliflozin prior to discharge showed a 36% higher likelihood of achieving clinical benefits within 90 days compared to placebo. Clinical benefits were reflected by the primary composite endpoint, which included all-cause mortality, frequency of heart failure events, time to first heart failure event, and symptom assessment via the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS). The study results were recently published inNature Medicine》magazine, and has been released at the American Heart Association's latest scientific conference in 2021.^[1],[2]

"The first few months after hospitalization are a particularly vulnerable period for patients with heart failure," said Adriaan Voors, Professor of Cardiology at the University Medical Center Groningen in the Netherlands and Principal Investigator of EMPULSE. "The current prognosis for patients hospitalized with heart failure is poor, indicating an urgent need for therapies that can improve clinical management during hospitalization to prevent rehospitalization or death. The significant clinical benefits demonstrated by empagliflozin compared to placebo will enhance our understanding of treating heart failure patients in the early post-discharge phase."

In the United States and Europe, more than one million patients are hospitalized each year due to heart failure, which is a leading cause of hospitalization. According to data from the U.S. National Readmission Database, patients admitted for heart failure have poor prognoses, with over 30% of patients readmitted within 90 days between 2010 and 2017.^[3] 

The overall clinical benefits of empagliflozin were consistent in patients with heart failure, whether new or previous, with or without diabetes, and with preserved or reduced ejection fraction.^。[1]Among exploratory secondary endpoints, treatment with empagliflozin significantly improved KCCQ-TSS scores from baseline to Day 90 by 4.5 points compared to placebo.^[1]

The safety outcomes of the EMPULSE clinical study were consistent with the established safety profile of empagliflozin. Investigators reported an acute kidney failure rate of 7.7% in the empagliflozin group compared to 12.1% in the placebo group, with a similar incidence of hypoglycemia (1.9% in the empagliflozin group vs. 1.5% in the placebo group). The rates of volume depletion were 12.7% and 10.2%, respectively.^[1]

"The EMPULSE clinical trial shows that adult patients hospitalized for acute heart failure who received empagliflozin on top of standard of care after stabilization were more likely to experience improvements in mortality, hospitalizations, and quality of life compared to those receiving placebo. Additionally, the mean increase in KCCQ-TSS scores indicates an overall improvement in patient-reported symptom burden," said Waheed Jamal, MD, Vice President and Head of Cardio-Metabolic Medicine at Boehringer Ingelheim. "These data demonstrate the clinical benefits for both new and existing heart failure patients, providing support for a broad population of adults living with this condition."

"The results of the EMPULSE clinical study provide increasing clinical evidence for our EMPOWER program, supporting the potential role of empagliflozin in a range of diseases related to the heart, kidneys, and metabolic system," said Vice President of Product Development at Eli Lilly and Company and Medical Doctor.Jeff Emmick"Said. 'The clinical benefits during the vulnerable period after discharge and consistent safety outcomes suggest that using empagliflozin in the hospital for suitable patients during this critical time can improve their prognosis.'"

The release of this data follows the recent approval of the indication for empagliflozin in the treatment of adult patients with symptomatic chronic heart failure in the United States. In 2021, empagliflozin was approved in the EU and the United States for the treatment of adult patients with heart failure with reduced ejection fraction.^[5],[6]Currently, the expanded indications in Europe and the United States include the treatment of patients with heart failure with preserved ejection fraction, a patient population for which there were previously no approved treatment options.

In addition, empagliflozin is currently used to treat adult patients with type 2 diabetes.^[4],[5],[6]A study is underway to investigate the impact of empagliflozin on heart failure hospitalization risk and mortality in high-risk heart failure patients post-myocardial infarction (heart attack). Empagliflozin is also currently being studied for the treatment of chronic kidney disease.^[7]