The benefit in the primary endpoint was independent of ejection fraction or diabetes status[1]
Empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent and significantly slowed kidney function decline
Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine

INGELHEIM, GERMANY & INDIANAPOLIS-- August 30, 2021 -- Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed an impressive 21 percent 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 empagliflozin 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,[1] Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent 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 60 million people worldwide 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.

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

“Heart failure is a complex, serious health issue and a leading cause of hospitalization,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “The risk of death in people with heart failure rises with each hospital admission and with kidney function decline. The landmark EMPEROR-Preserved trial shows that empagliflozin brings significant benefit, which is incredibly exciting and welcome news for both the medical and patient communities.”

“These impressive results will bring hope for the millions of people who currently have limited therapeutic options for a very serious, life-threatening condition,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Now there is a light at the end of the tunnel. If approved, empagliflozin would become the first clinically proven therapy across the full heart failure spectrum. The results of EMPEROR-Preserved offer an opportunity to fundamentally change the future for people with heart failure.”

The benefits demonstrated in the EMPEROR-Preserved trial are similar to those in the EMPEROR-Reduced trial, in which empagliflozin significantly reduced the relative risk of the composite endpoint of cardiovascular death or hospitalization for heart failure by 25 percent, compared with placebo, in adults with heart failure with reduced ejection fraction (HFrEF). Together, these studies demonstrate the benefits of empagliflozin for patients across the full heart failure spectrum.

Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes. Additionally, empagliflozin is approved for the treatment of adults with HFrEF in the European Union and the U.S.[9,12] Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure. Empagliflozin is also currently being investigated in chronic kidney disease.