Duke Clinical Research Institute (DCRI) inked a clinical trials collaborative deal with the world’s largest privately held drug company—Boehringer Ingelheim—and publicly traded Eli Lilly (NYSE:LLY) to launch the EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and mortality after an acute Myocardial Infarction). Duke, a leading academic medical center, will lead the investigation into whether empagliflozin can improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction (heart attack). Done in collaboration with partners Boehringer Ingelheim and Eli Lilly, the ladder industry sponsors will provide the important therapy and funding for the effort.
The Health Challenge: Heart Attacks
Ischemic heart disease, including acute myocardial infarction (heart attack), is the leading cause of death and disability in the world, with over 7 million acute cases every year. Those people suffering from myocardial infarction face 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 as possible.
The EMPACT-MI study involves 3,300 adults across at least 16 countries who have had a heart attack. The primary endpoint of the trial is to assess the effect of the drug on all-cause mortality and hospitalization for heart failure. Part of the EMPOWER program, the broadest and most comprehensive clinical trial exploring the impact of empagliflozin on the lives of people with cardio-renal-metabolic conditions.
Empagliflozin, sold under the name Jardiance (and others) is a medication used together with diet and exercise to treat type 2 diabetes. It can be less preferred than metformin and sulfonylureas. It also may be prescribed with additional medications such as metformin or insulin. In 2016, the U.S. Food and Drug Administration approved the drug to reduce cardiovascular death in adults with type 2 diabetes.
With a focus on the relationship between treatments and outcomes in real-world health system practice, this pragmatic trial-based partnership leverages DCRI’s experience in pragmatic trials by implementing innovative and efficient elements, such as remote follow-up and focused data collection methods enabling strong patient centric focus while ensuring high quality data.
What makes a Pragmatic Trial different?
Put simply, this class of trial focuses on the correlation between treatments and outcomes in real-world health system practice rather than emphasis on proving causative explanations for outcomes, which necessitates extensive deconfounding with inclusion and exclusion criteria so rigid they can make the trial results irrelevant to much of the real-world practice.
According to the NIH, pragmatic trials may test the same intervention as an explanatory trial but are in fact conducted in real-world practice settings, with standard patients and credentialed clinicians who may not have a research background, comments Marcel Salive.
Pragmatic trials are helpful when certain classes of patients need to be part of a study. For example, when eligibility requirements are too strict, researchers can relax eligibility requirements, controlling for exceptions in the study analysis.
Adrian Hernandez, MD, MHS, Co-Chair of the EMPACT-MI trial and DCRI Executive Director, reported on the collaboration representing “an important step in understanding how to safeguard and protect the lives of patients with acute myocardial infarction.” Dr. Hernandez continued, “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 a decrease progression to heart failure in people who have had a recent myocardial infarction.”
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.
About 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.