RIDGEFIELD, INDIANAPOLIS - 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 Jardiance (empagliflozin) versus placebo, which did not reach statistical significance.
Jardiance 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. 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 Jardiance over placebo. 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. Results were announced in collaboration with Duke Clinical Research Institute (DCRI) and simultaneously published in The New England Journal of Medicine.
'These results add to our understanding of SGLT2 inhibitors and contribute to the body of evidence across six clinical studies examining the potential for Jardiance to impact major outcomes in a broad population of adults with heart failure, chronic kidney disease or type 2 diabetes,' said Mohamed Eid, M.D., M.Sc., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolic Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 'Building on this strong foundation, we remain committed to leading efforts aimed at increasing awareness, generating real-world evidence and advancing care for people affected by interconnected cardiovascular, renal and metabolic diseases.'
The EMPACT-MI phase III trial investigated Jardiance 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.
'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, Jardiance 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 Jardiance 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.
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 Jardiance on all-cause mortality and hospitalization due to heart failure in adults who have had a heart attack. Participants had no history of chronic heart failure and were eligible regardless of type 2 diabetes and chronic kidney disease status. EMPACT-MI included more than 6,500 adults from 22 countries. Study participants were randomized to receive either Jardiance 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 is being conducted, analyzed, and reported in partnership with the Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim and Lilly providing funding.
About the EMPOWER program
The Alliance has developed the EMPOWER program to explore the impact of Jardiance 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 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.
Boehringer Ingelheim and Eli Lilly and Company
The Boehringer Ingelheim and Lilly Alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate their commitment, not only to the care of people with type 2 diabetes, but also to address areas of unmet medical need like heart failure and chronic kidney disease.
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.
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.
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.
Cautionary Statement Regarding Forward-Looking Statements
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 beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date or that Jardiance will receive additional regulatory approvals.
Contact:
Jennifer Forsyth
Email: jennifer.forsyth@boehringer-ingelheim.com
Tel: +1 (203) 791-5889
Niki Smithers
Email: smithersniki@lilly.com
Tel: +1 317-358-9074
ELI LILLY AND COMPANY 
