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.