Eli Lilly Says Jardiance Provides Significant Benefit In Adults Following Acute Heart Failure

(RTTNews) - Eli Lilly and Company (LLY) and Boehringer Ingelheim on Tuesday announced that adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance following stabilization and prior to discharge compared with placebo.

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.

The findings of the phase 3 Empulse trial 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."

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, the company said.

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.