Eli Lilly and Boehringer Ingelheim’s Jardiance Shows Benefits in Full Data Presented From EMPEROR-Preserved Study

August 27, 2021— Eli Lilly and Company and Boehringer Ingelheim announced that the full results from the landmark EMPEROR-Preserved phase 3 trial demonstrated that Jardiance (empagliflozin) showed a 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 a treatment to significantly improve outcomes for the full spectrum of heart failure patients, stated Eli Lilly and Boehringer Ingelheim. Additionally, the companies noted that 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.

The results were presented at the European Society of Cardiology (ESC) Congress 2021 held virtually August 27-30, 2021. The study was simultaneously published by Stefan D. Anker, MD, et al online ahead of print in The New England Journal of Medicine. Professor Anker, who is a heart failure cardiologist at Charité—Universitätsmedizin Berlin in Berlin, Germany, serves as the EMPEROR-Preserved Principal Investigator.

“For people with HFpEF, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition,” commented Prof. Anker in the companies’ press release. “[These] data bring hope for millions of patients suffering from HFpEF. 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.”

As summarized by the companies, EMPEROR-Preserved included 5,988 patients with heart failure. Of those patients, 4,005 had a left ventricular ejection fraction of ≥ 50% and 1,983 had a left ventricular ejection fraction < 50%. Trial participants were randomly assigned to Jardiance 10 mg (n = 2,997) or placebo (n = 2,991) once daily. The overall safety data were consistent with previous findings, confirming the safety profile of Jardiance.

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

The ESC presentation comes after the companies first announced on July 6 that the EMPEROR-Preserved phase 3 trial met its primary endpoint, establishing Jardiance as a 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 HFpEF.

On August 18, the companies announced FDA approval of Jardiance to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with HFrEF. Jardiance was the first treatment approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, stated the companies.

The Boehringer Ingelheim-Lilly Alliance plans for global regulatory submissions in HFpEF in 2021. Additionally, research is ongoing regarding the effects of Jardiance on hospitalization for heart failure and mortality in postmyocardial infarction patients with high risk of heart failure. Jardiance is also being investigated in chronic kidney disease.