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2021 | HFSA

Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

Industry News Industry

- The EMPEROR-Preserved phase III trial met its primary endpoint and demonstrated significant risk reduction with Jardiance for the composite of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction

- Heart failure with preserved ejection fraction has been classified as "the single largest unmet need in cardiovascular medicine"¹ based on prevalence, poor outcomes and absence of clinically proven therapies to date

- With approval, Jardiance would become the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients regardless of ejection fraction


RIDGEFIELD, Conn. and INDIANAPOLIS, July 6, 2021 /PRNewswire/ -- The EMPEROR-Preserved phase III trial met its primary endpoint, establishing Jardiance® (empagliflozin) as the first and only therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced the topline results today. When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance's efficacy in all forms of heart failure regardless of ejection fraction. The safety profile was generally consistent with the known safety profile of Jardiance.

"We look forward to presenting the EMPEROR-Preserved results at ESC 2021, which should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue. HFpEF has long been the most challenging form of heart failure to treat," said Professor Stefan Anker, heart failure cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved principal investigator. "Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure."