BOEHRINGER-INGELHEIM

Empagliflozin reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40 percent regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved^® Phase III trial.¹ In EMPEROR-Preserved^® , two thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50 percent) and one third had mildly reduced LVEF (greater than 40 percent but less than 50 percent).² The results were presented today at the American Society of Nephrology Kidney Week 2021, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.¹

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“Heart failure and chronic kidney disease are intimately linked — the risk of death in people with heart failure increases with kidney function decline,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program Clinical Investigator and Emeritus Professor of Therapeutics and Cardiology at the University of Lorraine, France. “The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for both patients and physicians. The findings underscore the potential value of empagliflozin across a wide range of kidney function in this heart failure population that includes people with preserved ejection fraction.”

Nearly half of adults with heart failure also have chronic kidney disease.³ Together, these conditions are associated with high mortality rates and risk for hospital admission.³ More than 60 million people worldwide have heart failure, and approximately half of them have HFpEF.^4,5 No currently approved treatments have been clinically proven to significantly improve outcomes across the full spectrum of heart failure.

“In those living with heart failure, including those with preserved ejection fraction, chronic kidney disease poses an additional challenge to managing these patients and contributes to the worsening and progression of heart failure,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “It is very encouraging to see the evidence from EMPEROR-Preserved^® , which shows cardiovascular and kidney benefits in these patients with heart failure, including those with HFpEF, and concomitant chronic kidney disease.”

As previously reported, 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 over 40 percent compared with placebo.² Empagliflozin also significantly reduced the risk of first and recurrent hospitalizations for heart failure and slowed kidney function decline.²

Over half (53.5 percent) of adults in EMPEROR-Preserved^® had chronic kidney disease (defined as eGFR below 60 mL/min/1.73 m² or UACR above 300 mg/g) at trial entry, and 9.7 percent had severe kidney impairment (eGFR below 30 mL/min/1.73 m² ).¹ The new prespecified sub-analysis of EMPEROR-Preserved^® demonstrated that the benefits seen in the overall population were consistent in adults with and without chronic kidney disease.¹ Empagliflozin consistently improved cardiovascular outcomes and slowed kidney function decline across the full range of kidney function down to an eGFR of 20 mL/min/1.73 m² .¹ Empagliflozin was well tolerated regardless of the level of baseline kidney function.¹

“This data marks an important milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom are in need of additional treatment options for these interconnected, complex conditions,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We look forward to continuing research with the goal of addressing the unmet needs of those with kidney impairment, including through our EMPA-KIDNEY Phase III trial of empagliflozin, from which we eagerly await a readout next year.”

Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.^6,7,8 Additionally, empagliflozin is approved for the treatment of adults with heart failure with reduced ejection fraction in the European Union and the U.S..^6,7 Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure.⁹ Empagliflozin is also currently being investigated in chronic kidney disease.¹⁰

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About the EMPEROR heart failure studies ^11,12

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies were two Phase III, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes:

• EMPEROR-Reduced^® [NCT03057977 ] investigated the safety and efficacy of empagliflozin in patients with chronic 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 ] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF.

• Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
• Number of patients: 5,988
• Completion: 2021
• Link to lay summary

About the EMPOWER program

The Alliance has developed the EMPOWER program to explore the impact of empagliflozin 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.¹³ Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 400,000 adults enrolled worldwide in clinical trials, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.

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.¹⁴ To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.¹⁵ It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.^4,5 Heart failure is highly prevalent 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-sided heart failure have either a reduced or a preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction.¹⁸ When the heart relaxes, the ventricle refills with blood.

• Heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out 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 pushed out to the body.¹⁸

People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.¹⁹ Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.²⁰

About cardio-renal-metabolic conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one 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 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, improvements in one system can lead to positive effects throughout the others.^21,22,23

Through our research and treatments, our goal is to support people’s health, restoring the balance 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 empagliflozin

Empagliflozin (marketed as Jardiance^® ) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several 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

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