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2021 | HFSA

Landmark trial demonstrates Jardiance® (empagliflozin) is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction

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RIDGEFIELD, Conn. and INDIANAPOLIS, August 27, 2021 – Full results from the landmark EMPEROR-Preserved phase III trial demonstrated that Jardiance® (empagliflozin) showed an impressive 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo. The benefit was independent of ejection fraction or diabetes status, establishing Jardiance as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients. The results were presented today at the European Society of Cardiology (ESC) Congress 2021 and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Key secondary endpoint analyses from the trial showed that Jardiance also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and significantly slowed kidney function decline.

“For people with heart failure with preserved ejection fraction, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition,” said Professor Stefan Anker, EMPEROR-Preserved principal investigator and heart failure cardiologist at Charité Berlin, Germany. “This data brings hope for millions of patients suffering from heart failure with a preserved ejection fraction. The primary endpoint was similarly improved in all subgroups of patients, in men and women, with and without diabetes, and regardless of their ejection fraction and kidney function level. This underlines the breadth of empagliflozin’s efficacy and its potential overall impact.”  

More than 6 million people in the U.S. have heart failure, and approximately half of them have HFpEF, which is also known as diastolic heart failure. HFpEF has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the absence of clinically proven therapies to date.1,2

EMPEROR-Preserved included 5,988 people with heart failure. Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50% or above and 1,983 had a LVEF below 50%. Trial participants were randomly assigned to Jardiance 10 mg (n=2,997) or placebo (n=2,991) once daily. The overall safety data was consistent with previous findings, confirming the well-established safety profile of Jardiance.