July 30, 2020: “Positive top-line results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced by Boehringer Ingelheim and Eli Lilly and Company.
EMPEROR-Reduced met its primary endpoint, demonstrating superiority with Jardiance® (empagliflozin) 10 mg compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care.
Overall the safety profile was similar to the known safety profile of Jardiance.
“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas.
“The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
Heart failure is the leading cause of hospitalization in the U.S., and the risk of death in people with heart failure rises with each hospital admission.
Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.
Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.
“With these positive top-line results from the EMPEROR-Reduced trial, we are excited to mark another important advancement for Jardiance,” 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. “There is an urgent need for new heart failure treatments, and these results show promise for the potential role Jardiance can play in improving the lives of adults living with this condition.”
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) Congress 2020 on August 29, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of Jardiance on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction – an area with no approved treatment options. EMPEROR-Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.
“These results build upon the already established cardiovascular benefits of Jardiance in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly.
“Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death.
Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how Jardiance can help adults around the world living with these 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 Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
- EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of Jardiance in patients with 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
- EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of Jardiance in patients with heart failure with preserved ejection fraction (HFpEF).
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.”