Study results show that individuals hospitalized for acute heart failure are 36% more likely to experience clinical benefit over 90 days if initiated on the drug following stabilization.
Individuals hospitalized for acute heart failure were about 36% more likely to experience clinical benefit over 90 days if initiated on empagliflozin following stabilization and prior to discharge compared with the placebo, Boehringer Ingelheim said in a statement.
The primary endpoint 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), which were reflected by clinical benefits.
“The first months following hospitalization for heart failure are a particularly vulnerable time for patients,” Adriaan Voors, professor of Cardiology at the University Medical Center in Groningen, Netherlands, said in a statement.
“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,” Voors said.
The overall clinical benefit with empagliflozin was consistent for individuals with new and pre-existing heart failure. Additionally, the benefit was consistent for those with and without diabetes, as well as those with preserved or reduced ejection fraction.
In the secondary endpoint, empagliflozin significantly improved KCCQ-TSS from baseline to day 90 by approximately 4.5 points compared with the placebo.
The safety results of the EMPULSE study were consistent with the well-established safety profile of the medication.
In addition, investigators reported that acute renal failure rates were approximately 7.7% for empagliflozin compared with 12.1% for the placebo. There was a similar low incidence of hypoglycemia in both groups, while volume depletion rates were 12.7% to 10.2%, respectively.
The EMPULSE study included 530 individuals who were hospitalized for acute heart failure, either de novo or decompensated chronic heart failure, and have been stabilized. It was used to evaluate the clinical benefit, safety, and tolerability of a once-daily dose of empagliflozin 10 mg compared with the placebo.
The findings of the EMPULSE study were published in Nature Medicine and were recently presented at the American Heart Association’s Late-Breaking Scientific Sessions 2021.
The data publication follows the marketing authorization of empagliflozin for the treatment of individuals with symptomatic chronic heart failure in the United States. In 2021, empagliflozin was approved in the European Union and the United States for the treatment of individuals with heart failure with reduced ejection fraction.
Furthermore, the expanded indication includes individuals with heart failure with preserved ejection fraction, which at the time had no approved treatment option.
Additionally, empagliflozin is indicated for the treatment of adults with insufficiently controlled type 2 diabetes.
Ongoing research is under way to determine the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction in individuals with a high risk of heart failure.
Investigators are also studying empagliflozin for use in chronic kidney disease.
Empagliflozin provided a significant clinical benefit in adults stabilized in hospital following acute heart failure in EMPULSE phase III trial. Boehringer Ingelheim. News release. March 1, 2022. Accessed March 3, 2022. https://www.boehringer-ingelheim.com/human-health/heart-diseases/heart-failure/empulse-trial-benefit-acute-heart-failure