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July 06, 2021
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EMPEROR-Preserved topline results: Empagliflozin improves outcomes in HFpEF

Empagliflozin reduced CV death or HF hospitalization compared with placebo in patients with HF with preserved ejection fraction, regardless of diabetes status, according to topline results of the EMPEROR-Preserved trial.

The trial is the first positive one of an agent to treat HFpEF.

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Boehringer Ingelheim and Eli Lilly announced the topline results of the trial of the SGLT2 inhibitor empagliflozin (Jardiance); full results will be presented at the European Society of Cardiology Congress in August.

The findings match those of EMPEROR-Reduced, in which, as Healio previously reported, empagliflozin reduced CV death or HF hospitalization in patients with HF with reduced ejection fraction (40% or less).

Stefan D. Anker

“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,” Stefan D. Anker, MD, PhD, heart failure cardiologist at Charité Berlin, Germany, and principal investigator of EMPEROR-Preserved, said in a press release. “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.”

The safety outcomes were similar to those of previous studies of empagliflozin, according to the release.

Empagliflozin is not yet approved in the U.S. to treat HF. According to the release, an FDA decision on an expanded indication for HFrEF is expected sometime in 2021, and the sponsors plan to file for an expanded indication for HFpEF in 2021.