Boehringer Ingelheim and Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial examining empagliflozin’s effects following an acute myocardial infarction
Ingelheim, Germany and Indianapolis, US,
- Ischemic heart disease, including myocardial infarction, is the leading cause of death in the world1
- EMPACT-MI is the first trial in the SGLT2 inhibitor class to investigate the prevention of heart failure after acute myocardial infarction in adults with and without diabetes
- The trial is part of the EMPOWER clinical trial program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions
Ingelheim, Germany and Indianapolis, US, 26 May 2020 – Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction). The collaboration will investigate whether empagliflozin can improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction, more commonly known as a heart attack. This randomized clinical trial will be conducted, analyzed and reported in partnership with the DCRI, with Boehringer Ingelheim and Lilly providing funding.
EMPACT-MI will include approximately 3,300 adults across at least 16 countries who have had an acute myocardial infarction. The primary endpoint of the trial is to assess the effect of empagliflozin on all-cause mortality and hospitalization for heart failure. The trial will be part of the EMPOWER program, the broadest and most comprehensive clinical trial program exploring the impact of empagliflozin on the lives of people with cardio-renal-metabolic conditions.
“This collaboration represents an important step in understanding how to safeguard and protect the lives of patients with acute myocardial infarction,” said Adrian Hernandez, M.D., M.H.S., Co-Chair of the EMPACT-MI trial and DCRI Executive Director. “Myocardial infarction is the leading cause of death in cardiology, and this is the first trial in the SGLT2 inhibitor class to investigate the potential to increase survival and decrease progression to heart failure in people who have had a recent myocardial infarction.”
Javed Butler, M.D., M.P.H., M.B.A., Chair of the EMPACT-MI trial and Professor and Chairman of the Department of Medicine at the University of Mississippi, added, “We are delighted to lead the EMPACT-MI trial to find out whether empagliflozin could become a new standard of care option to improve the outcomes and lives of people with acute myocardial infarction.”
Pragmatic clinical trials focus on the relationship between treatments and outcomes in real-world health system practice. This partnership will leverage the DCRI’s experience in pragmatic trials by implementing innovative and efficient trial elements, including remote follow-up and a focused data collection approach, which enable a strong patient focus while maintaining high data quality.
“We are pleased to collaborate with the Duke Clinical Research Institute on the EMPACT-MI trial to investigate the potential to increase survival and prevent heart failure from developing in adults who have had a heart attack. Despite current therapies, these patients have a high residual risk that could be addressed by the multiple benefits we have observed with SGLT2 inhibition,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“The EMPACT-MI trial is part of our broad and comprehensive clinical development program, which aims to explore how empagliflozin can improve health outcomes and fill therapeutic gaps for a broad range of patients suffering from cardio-renal-metabolic conditions,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly.
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.
About EMPACT-MI
EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction) is a streamlined, randomized, blinded, placebo-controlled, multi-center trial exploring the efficacy and safety of empagliflozin in adults hospitalized with an acute myocardial infarction.
About EMPOWER
The EMPOWER program reinforces the long-term commitment of the Boehringer Ingelheim and Eli Lilly and Company Alliance to improve outcomes for people living with cardiovascular and renal disease. EMPOWER is one of the largest cardiovascular clinical trial programs for an SGLT2 inhibitor to date with more than 13,000 adults worldwide. The aim of the program is preventing major clinical cardiovascular and renal outcomes that affect millions of adults worldwide as well as families and healthcare systems.
In addition to EMPACT-MI, the development program encompasses:
- EMPEROR reduced, in adults with chronic heart failure with reduced ejection fraction to prevent cardiovascular death and hospitalization due to heart failure
- EMPEROR preserved, in adults with chronic heart failure with preserved ejection fraction to prevent cardiovascular death and hospitalization due to heart failure
- EMPULSE, in adults hospitalized for acute heart failure to improve clinical and patient reported outcomes
- EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death
- EMPERIAL reduced, in adults with chronic heart failure with reduced ejection fraction to improve functional ability and patient reported outcomes
- EMPERIAL preserved, in adults with chronic heart failure with preserved ejection fraction to improve functional ability and patient reported outcomes
- EMPA-REG OUTCOME®, in adults with type 2 diabetes and established cardiovascular disease to prevent major adverse cardiovascular events, including cardiovascular death
- EMPRISE, a comparative effectiveness and safety study in routine clinical care.
About Acute Myocardial Infarction
Ischemic heart disease, including acute myocardial infarction (heart attack), is the leading cause of death and disability in the world,1 with over 7 million acute myocardial infarctions occurring every year.2 People who suffer an acute myocardial infarction are at a high risk of heart failure and death. Heart attacks occur when the blood supply to an area of the heart is blocked by a blood clot or by atherosclerosis (fatty deposits or plaques lining vessel walls) causing heart tissue to die. Rapid diagnosis and treatment to restore blood flow through the affected vessel are vital to save as much of the heart tissue as possible.3
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 It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.5 Heart failure is highly prevalent in people with diabetes;6 however, approximately half of all people with heart failure do not have diabetes.3,7
The empagliflozin heart failure program was initiated based on data from the EMPA-REG OUTCOME® trial, which assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care.8 EMPA-REG OUTCOME® was the first SGLT2 inhibitor trial to show a relative risk reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This population was comprised of more than 45% of adults with a prior myocardial infarction.8
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.9,10,11
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.12
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease.
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, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.
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.
More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to 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 http://www.lilly.com/ and https://newsroom.lilly.com/social-channels.
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 clinical trials to evaluate empagliflozin as a treatment for adults with acute myocardial infarction 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:
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Phone: +49 (6132) 77 172209
Stephan Thalen
Global Business Communications
Lilly Diabetes
Email: stephan.thalen@lilly.com
Phone: +1 (317) 276 8304
Kaitlin Jansen
DCRI Communications
Email : kaitlin.jansen@duke.edu
Phone : +1 (704) 995 2384
Susan Landis
DCRI Communications
Email : susan.landis@duke.edu
Phone : +1 (919) 668 5769
References
1 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–59.
2 Reed GW, Rossi JE, Cannon CP. Acute myocardial infarction. Lancet. 2017;389(10065):197–210.
3 National Heart, Lung and Blood Institute. Heart Attack. Available at: https://www.nhlbi.nih.gov/health-topics/heart-attack. Accessed: May 2020.
4 American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed: May 2020.
5 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):1789–1858.
6 Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;128(16):e240–e327.
7 Suskin N, McKelvie RS, Burns RJ, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. Eur Heart J. 2000;21:1368–75.
8 Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117–28.
9 Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: May 2020.
10 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
11 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
12 Vallon V and Thompson SC. Targeting renal glucose reabsorption to treat hyperglycaemia: the pleiotropic effects of SGLT2 inhibition. Diabetologia. 2017;60(2):215–25.
