RIDGEFIELD - Findings from a new exploratory sub-analysis of the EMPEROR-Reduced phase III trial showed that Jardiance (empagliflozin) reduced the risk of adverse cardiovascular and kidney events in adults with heart failure with reduced ejection fraction with and without diabetes regardless of chronic kidney disease status at baseline.
These results were shared today as an oral presentation at the
'On their own, heart failure and chronic kidney disease are each associated with an increased risk of hospitalizations and premature death from cardiovascular causes. The presence of one condition often accelerates the onset and progression of the other, further increasing this risk and leading to poorer prognoses,' said Faiez Zannad, M.D., Ph.D.,
As previously reported, EMPEROR-Reduced showed Jardiance reduced the relative risk of the combined endpoint of cardiovascular death or hospitalization for heart failure by 25% and of first and recurrent hospitalizations for heart failure by 30%, and slowed the decline in eGFR, a measure of kidney function, in adults with heart failure with reduced ejection fraction with and without diabetes. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint, including end stage kidney disease and a profound loss of kidney function, by 50%. In this new analysis of all endpoints, these benefits were consistently observed in subgroups of patients with and without chronic kidney disease at baseline, including patients with severe renal impairment. In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was similar to the well-established safety profile of Jardiance.
'Over half of people with heart failure have moderate to severe chronic kidney disease, yet, there remains a need for new treatment options that address these interconnected conditions,' said
'Heart failure and chronic kidney disease are common, life-threatening diseases that require improved treatment options. The EMPOWER clinical development program, including our ongoing EMPEROR-Preserved and EMPA-KIDNEY trials, explores the potential role Jardiance may play in improving outcomes for people with these conditions,' said
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The FDA also granted Fast Track designation in
The EMPEROR and EMPA-KIDNEY studies are part of the EMPOWER clinical program, 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.
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).
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 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.
Boehringer Ingelheim and
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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
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Email: jennifer.forsyth@boehringer-ingelheim.com
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