Results announced from EMPACT-MI phase III trial investigating the effect of Jardiance® (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack
The EMPACT-MI phase III clinical trial showed a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure or all-cause mortality for empagliflozin versus placebo, which did not reach statistical significance.1,2 Empagliflozin was initiated in adults within 14 days of an acute myocardial infarction, commonly known as a heart attack, and demonstrated a reassuring safety profile in this population.1,2 Additional pre-specified exploratory analyses revealed relative risk reductions of 23% for time to first hospitalization due to heart failure and 33% for total hospitalizations due to heart failure with empagliflozin over placebo.1,2 Detailed results from Boehringer Ingelheim and Eli Lilly and Company’s (NYSE: LLY) phase III EMPACT-MI trial were announced today at the American College of Cardiology’s 2024 Scientific Session & Expo.1 Results were announced in collaboration with the Duke Clinical Research Institute (DCRI) and simultaneously published in The New England Journal of Medicine.2
“These results add to the body of evidence, across six clinical trials, which examined empagliflozin’s potential to achieve reductions in hospitalization due to heart failure in a broad population, including those with chronic heart failure, chronic kidney disease and/ or type 2 diabetes,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “We continue to be fully committed to improving outcomes for people and families impacted by interconnected cardiovascular, renal, and metabolic diseases.”
The EMPACT-MI phase III trial investigated empagliflozin 10 mg compared with placebo, given once daily on top of standard of care, in more than 6,500 adults within 14 days of hospital admission for heart attack. The primary endpoint of the study was the composite of time to first hospitalization due to heart failure or all-cause mortality up to 26 months. Participants had no history of chronic heart failure and were eligible regardless of type 2 diabetes and chronic kidney disease status.1,2
"Despite remarkable advances in treatment, heart attack remains the most common cause of heart failure,” said Jeff Emmick, M.D., Ph.D., senior vice president, Product Development, Lilly. “There is still an unmet need to reduce the risk of new onset heart failure and other common complications after a heart attack. However, in adults who have chronic heart failure, empagliflozin has proven to be an important therapy for reducing the risk of cardiovascular death and heart failure hospitalizations, and has the potential to meet the needs of millions of people worldwide."
EMPACT-MI is part of the EMPOWER program, launched by the Boehringer Ingelheim and Lilly Alliance to explore the impact of empagliflozin on major patient outcomes across the spectrum of cardiovascular, renal and metabolic conditions including type 2 diabetes, chronic heart failure, heart attack and chronic kidney disease. Globally, more than 1 billion people live with these interconnected disorders, which are a leading cause of death worldwide.3
About EMPACT-MI
EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction) is a multicenter, randomized, parallel-group, double-blind, placebo-controlled superiority trial investigating the effect of empagliflozin on all-cause mortality and hospitalization due to heart failure in adults who have had a heart attack.1,2 Participants had no history of chronic heart failure and were eligible regardless of type 2 diabetes and chronic kidney disease status.1,2 EMPACT-MI included more than 6,500 adults from 22 countries. Study participants were randomized to receive either empagliflozin 10 mg or placebo, once daily, both on top of standard of care within 14 days of hospital admission for heart attack. The EMPACT-MI clinical trial was conducted, analysed, and reported in partnership with the Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim and Lilly providing funding.1,2
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.4,5 It is a widespread condition affecting over 15 million people in Europe and over 60 million people worldwide and expected to increase as the population ages.6,7 Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.8
About cardiovascular, renal and metabolic conditions
Boehringer Ingelheim and Lilly are committed to transform care for people with cardiovascular, renal and metabolic conditions, a group of interconnected disorders that affect more than 1 billion people worldwide and are a leading cause of death.3
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.9,10,11
Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardiovascular, renal and metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardiovascular, renal and metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
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 cardiovascular, renal and metabolic conditions. Cardiovascular, renal and 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 Lilly are working to advance knowledge of these interconnected systems and create care which that 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 cardiovascular, renal and metabolic conditions. With more than 700,000 adults enrolled worldwide in studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.
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 for people with type 2 diabetes and cardiovascular disease in its label in several countries.12,13 Empagliflozin is indicated in the EU in adults with type 2 diabetes, heart failure and most recently chronic kidney disease.14
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. 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, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn.
About the Duke Clinical Research Institute
The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative research. The institute conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany, and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release 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 Jardiance® 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 Jardiance® 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:
Melody Mileur
Boehringer Ingelheim
Email: melody.mileur@boehringer-ingelheim.com
Phone: +49 (6132) 77-171567
Niki Smithers
Eli Lilly and Company
Email: smithers_niki@lilly.com
Phone: +1 317-358-9074
References
1 EMPACT-MI full data presentation, presented on 6 April 2024 at the American College of Cardiology (ACC) Congress 2024 Scientific Session & Expo.
2 Butler, J. et al. Empagliflozin after Acute Myocardial Infarction. N Engl J Med, online publication on April 6, 2024, at NEJM.org. DOI: 10.1056/NEJMoa2314051.
3 Schechter M, et al. Cardiovasc Diabetol,2022: 21:104.
4 American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Last accessed: April 2024.
5 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. Last accessed: April 2024.
6 Lippi G, Sanchis-Gomar F. Global epidemiology and future trends of heart failure. AMJ. 2020;5:15
7 Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019;124(1):121-41.
8 Dunlay SM, Givertz MM. Aguilar E, 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.
9 Usman M, et al. Chronic Kidney Disease and Type 2 Diabetes. Arlington (VA): American Diabetes Association; 2021. DOI: 10.2337/db20211.
10 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.
11 García-Donaire A, Ruilope M. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol. 2011:975782.
12 Leon M, Maddox M. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World J Diabetes. 2015;6(13):1246–58.
13 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. Last accessed: April 2024.
14 Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Last accessed: April 2024.
