Landmark trial, EMPEROR-Preserved, demonstrates empagliflozin is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction

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Beirut, Lebanon, 01 November 2021 Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed an impressive 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo.1The benefit was independent of left ventricular ejection fraction (LVEF) or diabetes status,1 establishing empagliflozin as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients. The results were presented earlier this year at the European Society of Cardiology (ESC) Congress 20212 and published in The New England Journal of Medicine,1 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent and significantly slowed kidney function decline.1

“For people with heart failure with preserved ejection fraction, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition,” said Professor Stefan Anker, EMPEROR-Preserved Principal Investigator and Heart Failure Cardiologist at Charité Berlin, Germany. “This data brings hope for millions of patients suffering from heart failure with a preserved ejection fraction. The primary endpoint was similarly improved in all subgroups of patients, in men and women, with and without diabetes, and regardless of their ejection fraction and kidney function level. This underlines the breadth of empagliflozin’s efficacy and its potential overall impact.”   

More than 60 million people worldwide have heart failure and approximately half of them have HFpEF, which is also known as diastolic heart failure.[3],[4]

“While the prevalence of HFpEF continues to increase, mainly due to aging populations, its prognosis has not improved.[5] We aim to make significant contributions to healthcare, by focusing on serious health issues, like the full spectrum of heart failure, which has so far not been satisfactorily treated,” said Mohammed Al-Tawil, Regional Managing Director and Head of Human Pharma at Boehringer Ingelheim Middle East, Turkey and Africa (‘META’), “The impressive results provide conclusive evidence for the significant reduction in the risk of cardiovascular death or hospitalization for heart failure in all adults with HFpEF, an important achievement for Boehringer Ingelheim, and an opportunity to better serve the needs of patients.”

“Heart failure is a major concern in cardiovascular medicine and is challenging to treat. It is a progressive, debilitating and potentially fatal condition and often patients have overlapping comorbidities. Recently, HFpEF has been identified as a disease in itself rather than the result of all its comorbidities[6], clearly demonstrating a need for treatment options that improve outcomes for patients living with this disease, ” said Prof. Hadi Skouri, Director Heart Failure Program, Director Cardiac Care Unit, American University of Beirut Medical Centre.  

“In the past, treatment options to meet clinical needs were not available, particularly to reduce hospitalization among heart failure patients with preserved ejection fraction[7]. Considering the results of the EMPEROR Preserved trials, there is a clinically proven therapy for a highly prevalent type of heart failure, that accounts for almost half of all heart failure3,4. We have the opportunity to address the largest unmet need in cardiology and tackle the growing disease burden,” said Prof. Rabih Azar, Head of Cardiology Department at Hotel Dieu de France Hospital & Professor of Medicine, St. Joseph University, Beirut.

EMPEROR-Preserved included 5,988 people with heart failure.1 Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50 percent or above and 1,983 had a LVEF below 50 percent.1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.1 The overall safety data was consistent with previous findings, confirming the well-established safety profile of empagliflozin.[8]

The benefits demonstrated in the EMPEROR-Preserved trial are similar to those in the EMPEROR-Reduced trial, in which empagliflozin significantly reduced the relative risk of the composite endpoint of cardiovascular death or hospitalization for heart failure by 25 percent, compared with placebo, in adults with heart failure with reduced ejection fraction (HFrEF).[9] Together, these studies demonstrate the benefits of empagliflozin for patients across the full heart failure spectrum.

Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.[10],[11],[12]Additionally, empagliflozin is approved for the treatment of adults with HFrEF in the European Union and the U.S.13,[13]Following global approvals, Boehringer Ingelheim plans for local regulatory submissions for HFpEF across countries in the META region to ensure the treatment is readily available to patients at the earliest. 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.[14] Empagliflozin is also currently being investigated in chronic kidney disease.[15]

# Ends #

About the EMPEROR heart failure studies[16],[17] 
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 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.[18] To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.[19] It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.3,4 Heart failure is highly prevalent in people with diabetes;[20]however, more than half of all people with heart failure do not have diabetes.[21]

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.[22] 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.22
  • 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.22

People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.[23]Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.[24]

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.4,17

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.[25],[26],[27]

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 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. 9,10,11

About Boehringer Ingelheim 

Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

About Eli Lilly and Company 
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

Intended audiences

This press release is issued from the Boehringer Ingelheim Regional Headquarters in Dubai, UAE, and is intended to provide information about Boehringer Ingelheim’s global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and other press releases on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about clinical trials to evaluate empagliflozin as a treatment for adults with heart failure and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 

CONTACTS:

Hazar Alzaki

Head of Communications and Public Affairs 

Middle East, Turkey and Africa
Boehringer Ingelheim 
Email: [email protected]

References


[1] Anker S, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021;10.1056/NEJMoa2107038.

[2] Anker S. EMPEROR-Preserved: effect of empagliflozin on cardiovascular death and heart failure hospitalisations in patients with heart failure with a preserved ejection fraction, with and without diabetes. Presented on 27 August 2021 at the European Society of Cardiology (ESC) Congress 2021 – The Digital Experience.

[3] Andersen MJ, Borlaug BA. Heart failure with preserved ejection fraction: current understandings and challenges. Curr Cardiol Rep. 2014;16(7):501.

[4] GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858.

[5] Upadhya B, Kitzman DW. Heart failure with preserved ejection fraction: New approaches to diagnosis and management. Clin Cardiol. 2020; 43(2):145–55.

[6] Mohammed SF, Borlaug BA, Roger VL, et al. Comorbidity and ventricular and vascular structure and function in heart failure with preserved ejection fraction: a community-based study. Circ Heart Fail. 2012 Nov;5(6):710-9.

[7] Gevaert AB, Boen JRA, Segers VF, Van Craenenbroeck EM. Heart Failure With Preserved Ejection Fraction: A Review of Cardiac and Noncardiac Pathophysiology. Front Physiol. 2019;10:638. Published 2019 May 29. doi:10.3389/fphys.2019.00638

[8] Boehringer Ingelheim. Data on file.

[9] Packer M, Anker SD, Butler J, et al. Cardiac and Renal Outcomes With Empagliflozin in Heart Failure With a Reduced Ejection Fraction. N Engl J Med.2020;383:1413–24.

[10] Jardiance® (empagliflozin) tablets. European Product Information, approved April 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf. Accessed: August 2021.

[11] Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: August 2021.

[12] Jardiance® (Full Prescribing Information). Egypt, Jordan, Oman, UAE ; Boehringer Ingelheim

Middle East & North Africa (Scientific Office); Access July 2021.

[13] Boehringer Ingelheim. Press release. US FDA approves Jardiance® (empagliflozin) to treat adults living with heart failure with reduced ejection fraction. Available at: https://www.boehringer-ingelheim.us/press-release/us-fda-approves-jardiance-empagliflozin-treat-adults-living-heart-failure-reduced. Accessed: August 2021.  

[14] ClinicalTrials.gov. EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction). Available at: https://clinicaltrials.gov/ct2/show/NCT04509674. Accessed: August 2021.

[15] ClinicalTrials.gov. EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin). Available at:https://www.clinicaltrials.gov/ct2/show/NCT03594110. Accessed: August 2021.

[16] ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03057977. Accessed: August 2021.

[17] ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03057951. Accessed: August 2021.

[18] American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: August 2021.

[19] American Heart Association. Types of Heart Failure. Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/types-of-heart-failure. Accessed: August 2021.

[20] Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019;124(1):121–41.

[21] Dunlay SM, Givertz MM, Aguilar D, et al. Type 2 Diabetes Mellitus and Heart Failure: A Scientific Statement From the American Heart Association and the Heart Failure Society of America. Circulation. 2019;140:e294–e324.

[22] American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement. Accessed: August 2021.

[23] Calvert MJ, Freemantle N, Cleland JGF. The impact of chronic heart failure on health‐related quality of life data acquired in the baseline phase of the CARE‐HF study. Eur J Heart Fail. 2005;7(2):243–51.

[24] Sarnak MJ. A patient with heart failure and worsening kidney function. Clin J Am Soc Nephrol. 2014;9(10):1790–98.

[25] García-Donaire JA, Ruilope LM. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol. 2011;2011:975782.

[26] Leon BM, Maddox TM. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World J Diabetes. 2015;6(13):1246–58.

[27] Thomas M, Cooper M, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol. 2015;12:73–81.

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