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
Heart failure is the leading cause of hospitalization in the
'With these positive top-line results from the EMPEROR-Reduced trial, we are excited to mark another important advancement for Jardiance,' said
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the
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
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.
About the EMPOWER Program
The Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER program, Boehringer Ingelheim and
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body's demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.
The Jardiance heart failure program was initiated based on data from the EMPA-REG OUTCOME trial, which assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care.
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and
The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.
Through our research and treatments, our goal is to support people's health, restoring the harmony between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma,
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
About
About
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects
Contact:
Tel: (203) 791-5889
Email: jennifer.forsyth@boehringer-ingelheim.com
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