INGELHEIM, Germany & INDIANAPOLIS – (COMMERCIAL THREAD) – Empagliflozin reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed the decline in renal function in adults with heart failure with left ventricular ejection fraction (LVEF) greater than 40%, regardless of baseline chronic kidney disease status, based on the results of a new predefined EMPEROR-Preserved sub-analysis® Phase III trial.1 In the EMPEROR-Preserved®, two-thirds of the adults enrolled had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50%) and one-third had a slightly reduced LVEF (greater than 40% but less than 50%).2 The results were presented today at the American Society of Nephrology Kidney Week 2021, announced Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).1
“Heart failure and chronic kidney disease are inextricably linked – the risk of death in people with heart failure increases with declining kidney function, ”said Faiez Zannad, MD, Ph.D., clinical investigator of the EMPEROR program and Emeritus Professor of Therapeutics and Cardiology at the University of Lorraine, France. “The consistent benefits demonstrated in reducing severe heart failure events and slowing the decline in kidney function regardless of chronic kidney disease status are welcome results for both patients and physicians. The results highlight the potential value of empagliflozin in a wide range of renal functions in this heart failure population which includes people with preserved ejection fraction.
Almost half of adults with heart failure also have chronic kidney disease.3 Together, these conditions are associated with high death rates and a risk of hospitalization.3 More than 60 million people worldwide suffer from heart failure, and about half of them suffer from ICFpEF.4.5 No currently approved treatment has been clinically proven to significantly improve outcomes across the spectrum of heart failure.
“In people with heart failure, including those whose ejection fraction is preserved, chronic renal failure poses an additional challenge in the management of these patients and contributes to the worsening and progression of the disease. ‘heart failure,’ said Waheed Jamal, MD, corporate vice president and head of CardioMetabolic. Medicine, Boehringer Ingelheim. “It is very encouraging to see the evidence of EMPEROR-Preserved®, which shows cardiovascular and renal benefits in these patients with heart failure, including those with ICFpEF, and concomitant chronic renal failure.
As previously stated, EMPEROR-Preserved® showed that empagliflozin significantly reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF greater than 40% compared to placebo.2 Empagliflozin also significantly reduced the risk of initial and recurrent hospitalizations for heart failure and slowing decline in kidney function.2
More than half (53.5 percent) of adults in EMPEROR-Preserved® had chronic kidney disease (defined as an eGFR less than 60 ml / min / 1.73 m2 or UACR greater than 300 mg / g) at entry into the trial, and 9.7% had severe renal impairment (eGFR less than 30 mL / min / 1.73 m2).1 The new predefined sub-analysis of EMPEROR-Preserved® demonstrated that the benefits seen in the general population were consistent in adults with and without chronic kidney disease.1 Empagliflozin consistently improved cardiovascular outcomes and slowed the decline in renal function across the range of renal function up to an eGFR of 20 ml / min / 1.73 m2.1 Empagliflozin was well tolerated regardless of the level of initial renal function.1
“These data mark a milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom need additional treatment options for these complex and interconnected conditions, ”said Jeff Emmick, MD , Ph.D., Vice President, Product Development, Lilly. “We look forward to continuing research to address the unmet needs of people with kidney disease, including through our EMPA-KIDNEY Phase III trial of empagliflozin, which we look forward to reading this year. next.
Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.6.7.8 In addition, empagliflozin is approved for the treatment of adults with heart failure with reduced ejection fraction in the European Union and the United States.6.7 Boehringer Ingelheim and Lilly Alliance are planning global regulatory submissions for HFpEF in 2021. Research is ongoing into the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with a high risk of heart failure.9 Empagliflozin is also currently being studied in chronic kidney disease.ten
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About the EMPEROR Heart Failure Studies11.12
The EMPEROR (EMPagliflozin outcomE trial in patients with chrOnic heaRt Failure) chronic heart failure studies were two phase III, randomized, double-blind trials that evaluated once-daily empagliflozin versus placebo in patients with adults with chronic heart failure or chronic heart failure, with or without diabetes:
- EMPEROR-Reduced® [NCT03057977] studied the safety and efficacy of empagliflozin in patients with chronic heart failure.
Primary endpoint: time to first event of cardiovascular death or hospitalization for heart failure
Number of patients: 3,730
- EMPEROR-Preserved® [NCT03057951] studied the safety and efficacy of empagliflozin in patients with chronic CFI.
Primary endpoint: time to first event of cardiovascular death or hospitalization for heart failure
Number of patients: 5,988
- Link to the lay summary
About the EMPOWER program
The Alliance developed the EMPOWER program to explore the impact of empagliflozin on key cardiovascular and renal clinical outcomes under a range of cardio-renal-metabolic conditions. Cardio-renal and metabolic diseases are the leading cause of death worldwide and account for up to 20 million deaths per year.13 Through the EMPOWER program, Boehringer Ingelheim and Lilly strive to advance knowledge of these interconnected systems and create care that provides integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER strengthens the Alliance’s long-term commitment to improving outcomes for people living with cardio-renal-metabolic disorders. With over 400,000 adults enrolled in clinical trials worldwide, this is one of the largest and most comprehensive clinical programs to date for an SGLT2 inhibitor.
About heart failure
Heart failure is a progressive, debilitating, and life-threatening disease that occurs when the heart cannot provide adequate circulation to meet the body’s need for oxygenated blood.14 To do this, it requires an increase in blood volume leading to a buildup of fluid (congestion) in the lungs and peripheral tissues.15 It is a common disease that affects more than 60 million people worldwide and is expected to increase as the population ages.4.5 Heart failure is very common in people with diabetes;16 however, more than half of all people with heart failure do not have diabetes.17
There are different types of heart failure. People with left heart failure have a reduced or preserved ejection fraction. The ejection fraction is a measure of the percentage of blood that the left ventricle pumps with each contraction.18 When the heart relaxes, the ventricle fills with blood.
- Heart failure with preserved ejection fraction occurs when the heart’s left ventricle is unable to relax and fill properly with blood, reducing the amount of blood available to be pumped to the body.18
- Heart failure with reduced ejection fraction occurs when the left ventricle of the heart is not able to contract effectively, which means that the heart cannot pump with enough force, so less blood is expelled to the body.18
People with heart failure often suffer from shortness of breath and fatigue, which can seriously affect their quality of life.19 People with heart failure often also have impaired kidney function, which can have a significant negative impact on the prognosis.20
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and Lilly are committed to transforming the care of people with cardio-renal-metabolic disorders, a group of interconnected disorders that affect more than a billion people worldwide and are a leading cause of death.5.13
The cardiovascular, renal, and metabolic systems are interconnected and share many of the same risk factors and pathways throughout the disease continuum. Dysfunction of one system can accelerate the onset of others, leading to the progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to risk. increased cardiovascular death. Conversely, improvements to one system can have positive effects on others.21,22,23
Through our research and treatments, our goal is to support people’s health, restoring the balance between interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is threatened by cardio-renal-metabolic disorders, we will continue to take a multidisciplinary approach to care and focus our resources on filling the treatment gaps.
Empagliflozin (marketed as Jardiance®) is a highly selective, once-daily, oral sodium-glucose co-transporter 2 (SGLT2) inhibitor and the first type 2 diabetes drug to include cardiovascular death risk reduction data on its label in multiple countries.6.7.8
Please click on the following link for “Notes to Editors” and “References” https://www.boehringer-ingelheim.com/press-release/emperor-preserved-kidney-subanalysis