Todays approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and more time with their families.
Marketing authorization is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization due to heart failure. The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.
Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status. We look forward to collaborating with regulators in Europe and beyond to ensure access to this trusted therapy.”
As we enter this new chapter of heart failure management, we can now look ahead to results from the EMPEROR-Preserved trial, expected this year. This trial will explore empagliflozin in heart failure with preserved ejection fraction, in adults with or without diabetes,” continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We are committed to finding solutions for the millions of people who live with heart failure and important metabolic conditions around the world.”
Heart failure is often associated with other diseases of the cardio-renal-metabolic systems such as type 2 diabetes and kidney disease. Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others. Heart failure is a very common and severe complication of a heart attack4,5 and occurs when the heart cannot pump sufficient blood to the rest of the body. There are two forms of the condition; heart failure with reduced ejection fraction means the heart cannot contract normally, while preserved ejection fraction means the heart cannot properly fill with blood. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.
The EMPEROR-Reduced trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
About the EMPEROR Heart Failure Studies
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, with or without diabetes, who are receiving current standard of care:
• EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 3,730
• Completion: 2020
• Link to lay summary
• EMPEROR-Preserved[NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 5,988
• Completion: 2021
