EMPULSE: Empagliflozin vs. Placebo in Improving Outcomes in Acute HF Patients

Initiation of empagliflozin in patients hospitalized for acute heart failure resulted in significant clinical benefit, including reduced rates of rehospitalization and death, within 90 days compared with placebo, according to findings from the EMPULSE trial presented Nov. 14 during AHA 2021. Benefits were observed regardless of the type of heart failure or diabetes status.

The trial enrolled 530 adults (average of 68 years, 66% men) who were randomized to receive 10 mg of empagliflozin for 90 days, or placebo for 90-days. The primary outcome was a composite of the number of deaths, heart failure-related events, time to the first heart failure event, or an improved score of at least five points on the Kansas City Cardiomyopathy (KCC) Questionnaire.

Overall results found that those treated with empagliflozin were 36% more likely to experience a clinical benefit, such as reduced all-cause mortality, fewer heart failure events and an improvement in heart failure symptoms compared to the study participants who received the placebo. When broken down by outcomes, researchers observed a 4.2% reduction in all-cause mortality in the empagliflozin group compared with 8.3% in the placebo group, while heart failure events occurred in 10.6% of those in the empagliflozin group compared with 14.7% in the placebo group. The placebo-adjusted mean difference between the two groups at 90 days on the KCC Questionnaire was 4.5 points.

"This is the first time we have really seen this type of medication work so effectively and safely in patients who were hospitalized for acute heart failure, regardless of heart failure history or diabetes status," says the study's lead author Adriaan Voors, MD, PhD. "These results may lead to earlier and more frequent treatment with empagliflozin, which may improve the lives of more people with heart failure."

Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: AHA Annual Scientific Sessions, American Heart Association, AHA21, Heart Failure, Metabolic Syndrome

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