Business Wire

Boehringer Ingelheim and Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial examining empagliflozin’s effects following an acute myocardial infarction

Share

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200526005445/en/

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

Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/dcri-collaboration-empact-mi

Contact information

Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
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

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CESTPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing

BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CESTPress release

Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China

U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CESTPress release

Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th

Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CESTPress release

Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp

Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CESTPress release

Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k

Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CESTPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom