RIDGEFIELD, Conn. and INDIANAPOLIS, June 5, 2022 /PRNewswire/ -- Two analyses of the final U.S. data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study show that Jardiance® (empagliflozin) was associated with a reduction in risk of hospitalization for heart failure compared with two other classes of glucose-lowering therapies in adults with type 2 diabetes in routine care. Relative risk reductions were 50% versus dipeptidyl peptidase-4 (DPP-4) inhibitors and 30% versus glucagon-like peptide 1 (GLP-1) receptor agonists. The results were presented on behalf of Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the American Diabetes Association Scientific Sessions 2022 in New Orleans.
"With more than 29 million people in the U.S. diagnosed with type 2 diabetes, up to 22% of whom may also have heart failure, it is critical that healthcare professionals caring for this population have treatments that demonstrate cardiovascular effectiveness in routine care," said Elisabetta Patorno, M.D., Dr.P.H., Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and associate professor of medicine, Harvard Medical School, and study co-investigator. "These five-year results from EMPRISE, showing empagliflozin was associated with a decreased risk of hospitalization for heart failure and for death, are encouraging data for adults with type 2 diabetes and their care team."
Compared with DPP-4 inhibitors, Jardiance was also associated with a 40% reduction in relative risk of all-cause mortality in people who had Medicare. In the overall EMPRISE population, Jardiance was associated with a 12% reduction in the risk of the composite outcome of myocardial infarction or stroke compared with DPP-4 inhibitors.
Compared with GLP-1 receptor agonists, Jardiance was associated with similar risks of heart attack, stroke and all-cause mortality. All results for Jardiance compared with GLP-1 receptor agonists, and with liraglutide (a GLP-1 receptor agonist) specifically, were consistent for people with and without cardiovascular disease.
Results from the EMPRISE real-world study, which assessed the first five years of use of Jardiance in the U.S., complement previously reported data from the landmark EMPA-REG OUTCOME® trial, in which Jardiance showed a 35% relative risk reduction in hospitalization for heart failure compared with placebo in adults with type 2 diabetes and established cardiovascular disease. EMPA-REG OUTCOME also showed a 38% relative risk reduction in cardiovascular death with Jardiance versus placebo.
"People with type 2 diabetes are four times as likely to be hospitalized for heart failure, and repeated hospitalizations lead to worse outcomes, making treatment options that improve clinical outcomes crucial," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "These findings suggest that treatment with Jardiance can help reduce heart failure hospitalizations compared to other classes of diabetes therapies, with a well-understood safety and tolerability profile."
The EMPRISE findings confirmed the well-established safety profile of Jardiance. Compared with DPP-4 inhibitors, Jardiance was associated with a reduction in relative risk of acute kidney injury. There was an increase in relative risk of hospitalization for diabetic ketoacidosis, which is consistent with Jardiance's known safety information. Risks for lower-limb amputations, fractures and renal and bladder cancers were similar.
"We are pleased to present the final data from EMPRISE in the U.S., which encompasses information from nearly 500,000 adults in a real-world care setting," said Leonard Glass, M.D., F.A.C.E., vice president of Diabetes Global Medical Affairs, Lilly. "As we strive to help fill unmet treatment needs, this study reinforces our longstanding commitment to people living with cardio-metabolic conditions. Building upon our robust clinical trial program, EMPRISE highlights the potential of Jardiance to improve health outcomes in routine clinical practice."
About EMPRISE
EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME trial results by providing data on the comparative effectiveness and safety of Jardiance in routine clinical care versus DPP-4 inhibitors or GLP-1 receptor agonists.
The final analyses of EMPRISE U.S. data assessed the first five years of Jardiance use in nearly 500,000 adults with type 2 diabetes, with and without cardiovascular disease, in the U.S. between 2014 and 2019: the first included more than 230,000 adults who initiated either Jardiance or a DPP-4 inhibitor (115,116 adults in each treatment arm); the second included more than 260,000 adults who initiated either Jardiance or a GLP-1 receptor agonist (130,408 adults in each treatment arm).
Additional EMPRISE studies including Asia and Europe will provide insights from different regions of the world with an international perspective on the use of Jardiance in routine clinical care.
EMPRISE U.S. was initiated and led by academic researchers from the Division of Pharmacoepidemiology at Brigham and Women's Hospital and Harvard Medical School, Boston. The study is part of an academic collaboration between Brigham and Women's Hospital and Boehringer Ingelheim.
Prioritizing Cardio-Renal-Metabolic Care
Through research and educational initiatives, Boehringer Ingelheim and Lilly are driven to redefine care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.
The cardiovascular, renal (kidney) and metabolic systems are closely intertwined and share many of the same disease-related pathways. Dysfunction in one system may accelerate the onset of dysfunction in others, resulting in the progression of comorbid diseases such as type 2 diabetes, heart failure and chronic kidney disease. Conversely, improving the health of one system can lead to positive effects across the others and can help reduce the risk for further complications.
Understanding their interconnected nature, we are working to advance treatments for people with cardio-renal-metabolic conditions. It is only through a holistic approach to care that we can truly transform outcomes and restore the harmony among these critical systems.
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).
JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.
IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you are on dialysis.
JARDIANCE can cause serious side effects, including:
You may be at a higher risk of dehydration if you:
Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
If you have any of these symptoms, stop taking JARDIANCE and contact your healthcare provider or go to the nearest emergency room right away.
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.
These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist.
Before taking JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
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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.
About Lilly
Lilly unites caring with discovery to create medicines that 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 47 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. To learn more, visit lilly.com and lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn.
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, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020, Boehringer Ingelheim achieved net sales of around 22.33 billion USD (19.57 billion EUR). Our significant investment of over 4.2 billion USD (3.7 billion EUR) in 2020 (18.9% of net sales) 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.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance as a treatment for adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, and as a potential treatment for adults with cardio-renal-metabolic conditions 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 can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
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CONTACTS:
Sheryl van der Hilst
Senior Associate Director, Communications
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: [email protected]
Phone: (914) 772-7973
Stephan Thalen
Global Business Communications
Lilly Diabetes and Lilly USA, LLC
Email: [email protected]
Phone: (317) 903-5640
SOURCE Eli Lilly and Company
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