- In this clinical first for adults with heart failure with preserved ejection fraction, Jardiance demonstrated an impressive 21% relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure
- The benefit in the primary endpoint was independent of ejection fraction or diabetes status
- Jardiance also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and significantly slowed kidney function decline
- Results from the EMPEROR-Preserved phase III trial were presented today at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2021 /PRNewswire/ -- 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.
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.
"In the first successful trial in this difficult-to-treat form of heart failure, Jardiance demonstrated a statistically significant improvement in outcomes for adults with heart failure across the spectrum of left ventricular ejection fraction in the trial. This is the kind of news that has the potential to change treatment paradigms, and it's thrilling to see this level of benefit in both hospitalizations and kidney function," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "We are moving quickly to share this impressive data with regulators and are looking forward to potentially bringing this breakthrough treatment option to a growing and underserved population."
"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, Jardiance 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 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.
Earlier this month, the U.S. Food and Drug Administration approved Jardiance to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with HFrEF. Jardiance was the first type 2 diabetes treatment approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. The Boehringer Ingelheim-Lilly Alliance plans for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of Jardiance on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease.
