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RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 29, 2020 /PRNewswire/ -- Full results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that Jardiance® (empagliflozin) was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure. The trial evaluated the effect of adding Jardiance (10 mg) versus placebo to standard of care. The results will be presented today at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30%. Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with Jardiance than with placebo.
"Heart failure is a devastating and debilitating cardiovascular condition. Not only does it limit quality of life, but it is also a progressive disease that requires repeated hospitalizations and is accompanied by a loss in kidney function," said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas. "Results from the EMPEROR-Reduced trial show that, when given to adults with heart failure with reduced ejection fraction, empagliflozin reduces the number of heart failure hospitalizations while slowing the decline of kidney function. These results are highly statistically significant and clinically important."
In an exploratory analysis, the absolute risk reduction observed in the primary endpoint of EMPEROR-Reduced corresponded to a number needed to treat of 19 patients over 16 months to prevent one cardiovascular death or hospitalization for heart failure. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint*, including end stage kidney disease and a profound loss of kidney function, by 50%.
In EMPEROR-Reduced, the efficacy results were achieved with a simple dosing regimen, with once daily dosing and no need for titration. The safety profile was similar to the well-established safety profile of Jardiance. There were no clinically meaningful differences in adverse events, including hypovolemia (decreased blood volume), hypotension (low blood pressure), volume depletion (loss of fluids), renal insufficiency (poor kidney function), hyperkalemia (high potassium levels) or hypoglycemic events (low blood sugar) compared with placebo.
Heart failure affects over 60 million people worldwide, with more than one million people being hospitalized due to the condition every year in the U.S. Heart failure occurs when the heart cannot pump sufficient blood to the rest of the body and is the most common and severe complication of a heart attack. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life. Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.
"Jardiance transformed the treatment paradigm as the first and only oral diabetes medicine proven to significantly reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, based on the EMPA-REG OUTCOME® trial," 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. "The positive results from EMPEROR-Reduced build on this legacy and demonstrate the potential of Jardiance to improve cardiovascular outcomes and slow kidney function decline in adults with heart failure, with and without diabetes. We look forward to submitting these data to regulatory authorities later this year."
"Tens of millions of people live with heart failure and kidney disease," said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "Results from EMPEROR-Reduced show that Jardiance can help improve heart failure outcomes while also slowing kidney function decline. We are excited to share these data and, through our ongoing EMPOWER program, hope to redefine how people living with these conditions are treated."
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options. EMPEROR-Preserved results are expected in 2021.
Additionally, the ongoing EMPA-KIDNEY study is evaluating the effect of Jardiance on the progression of kidney disease and occurrence of cardiovascular death in adults with established chronic kidney disease, with and without diabetes. The FDA has also granted Fast Track designation to Jardiance for the treatment of chronic kidney disease, demonstrating the urgent need for new treatment options for people living with the condition worldwide. Results from EMPA-KIDNEY are expected in 2022.
The EMPEROR and EMPA-KIDNEY studies are part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions. The program also includes the EMPACT-MI study, which will investigate the effect of Jardiance on all-cause mortality and hospitalization for heart failure in adults, with and without diabetes, who have had a heart attack, and the EMPULSE study, which is exploring Jardiance in adults, with and without diabetes, who are hospitalized for acute heart failure and have been stabilized.
*Composite exploratory endpoint included chronic dialysis or renal transplant or sustained reduction of ≥ 40% in eGFR (CKD-EPI) or a sustained eGFR <15 ml min 1.73m2 (for patients with baseline egfr ≥ 30) or sustained < 10 30 1.73m2).< p>
About the EMPEROR Heart Failure Studies The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two phase III, randomized, double-blind trials investigating once-daily Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
About the EMPOWER programThe Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-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 eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 257,000 adults studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.
The development program encompasses:
About Heart FailureHeart 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. It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.
The Jardiance heart failure program was initiated based on data from the EMPA-REG OUTCOME trial, which assessed the effect of Jardiance (10 mg or 25 mg once daily) in adults with type 2 diabetes and established cardiovascular disease when added to standard of care, compared with placebo.
About Cardio-Renal-Metabolic ConditionsBoehringer Ingelheim and Lilly are driven to transform 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 and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.
Through our research and treatments, our goal is to support people's health, restoring the harmony between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
What is JARDIANCE? (www.jardiance.com) JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATIONDo not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you have severe kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
You may be at a higher risk of dehydration if you:
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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 doctor or pharmacist.
Before taking JARDIANCE, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor 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.
CL-JAR-100057 01.27.2020
Boehringer Ingelheim and Eli Lilly and CompanyIn 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. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.
About Boehringer IngelheimMaking 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, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) 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.
About Lilly DiabetesLilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.
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 belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee 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.
P-LLYMPR-US-101351
CONTACT:Jennifer ForsythDirector, Public RelationsBoehringer Ingelheim Pharmaceuticals, Inc.Email: jennifer.forsyth@boehringer-ingelheim.com Phone: (203) 791-5889
Stephan ThalenGlobal Business CommunicationsLilly Diabetes and Lilly USAEmail: stephan.thalen@lilly.com Phone: (317) 903-5640
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