RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I December 13, 2019 I Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to functional endpoints with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. The safety profile seen in the EMPERIAL trials was similar to the currently known safety profile of Jardiance and no new safety risks were identified.
The EMPERIAL trials, which included people with and without diabetes, deliver novel safety data for Jardiance in non-diabetic patients with heart failure. In addition, EMPERIAL-Preserved is the first trial to deliver safety data for Jardiance in heart failure with preserved ejection fraction.
“Our large heart failure clinical program underscores our dedication to researching new options for people living with this condition,” 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 EMPERIAL trials set a high bar for Jardiance to demonstrate an improvement in exercise ability in people with chronic heart failure, and we continue to believe in its potential to improve clinical outcomes. The ongoing EMPEROR trials—which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life—remain the cornerstone of our heart failure program, and we look forward to sharing initial results in 2020.”
The EMPERIAL trials used the six-minute walk test, which measures the distance a person can walk in six minutes, to evaluate changes in exercise ability over 12 weeks. For other heart failure guideline-recommended therapies, there have been divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.
The ongoing empagliflozin heart failure program also includes the EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE and EMPA-VISION studies. The program, which will include more than 10,000 adults, investigates the effects of empagliflozin on heart failure-related outcomes and patient-related outcomes in people with heart failure. The EMPERIAL studies were initiated based on data obtained from the EMPA-REG OUTCOME® trial, in which Jardiance showed a 38% relative risk reduction in cardiovascular death and a 35% relative risk reduction in hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease, compared to placebo.
“The EMPERIAL trials highlight our commitment to listening to patients’ needs and studying the impact of our treatments on important measures such as quality of life,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for people with cardiorenal metabolic conditions, including adults with chronic heart failure.”
Full results from the EMPERIAL trials will be shared in 2020.
About EMPERIAL
EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks’ treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.
- EMPERIAL-preserved [NCT03448406]: investigated Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 315
- Completed: October 9, 2019
- EMPERIAL-reduced [NCT03448419]: investigated Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 312
- Completed: October 7, 2019
*Ejection fraction is a measurement expressed as a percentage of the amount of blood that leaves the heart each time it contracts, related to the total blood volume of the heart chambers. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.
HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.
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. It is a widespread condition affecting 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. Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S.
There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the U.S. and Europe.
About Cardiorenal Metabolic Conditions
Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. A team approach to optimize patient care by coordinating treatment of related comorbidities, including the use of emerging therapies with broad cardiorenal metabolic effects, may improve outcomes for people with serious chronic conditions such as these.
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).
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 to help those living with heart failure or chronic kidney disease.
Currently, no Boehringer Ingelheim and Lilly products are approved for the treatment of heart failure or chronic kidney disease.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients’ lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.
In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 percent of net sales.
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 Diabetes
Lilly 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 and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly 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.
SOURCE: Eli Lilly
Post Views: 167
RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I December 13, 2019 I Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to functional endpoints with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. The safety profile seen in the EMPERIAL trials was similar to the currently known safety profile of Jardiance and no new safety risks were identified.
The EMPERIAL trials, which included people with and without diabetes, deliver novel safety data for Jardiance in non-diabetic patients with heart failure. In addition, EMPERIAL-Preserved is the first trial to deliver safety data for Jardiance in heart failure with preserved ejection fraction.
“Our large heart failure clinical program underscores our dedication to researching new options for people living with this condition,” 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 EMPERIAL trials set a high bar for Jardiance to demonstrate an improvement in exercise ability in people with chronic heart failure, and we continue to believe in its potential to improve clinical outcomes. The ongoing EMPEROR trials—which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life—remain the cornerstone of our heart failure program, and we look forward to sharing initial results in 2020.”
The EMPERIAL trials used the six-minute walk test, which measures the distance a person can walk in six minutes, to evaluate changes in exercise ability over 12 weeks. For other heart failure guideline-recommended therapies, there have been divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.
The ongoing empagliflozin heart failure program also includes the EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE and EMPA-VISION studies. The program, which will include more than 10,000 adults, investigates the effects of empagliflozin on heart failure-related outcomes and patient-related outcomes in people with heart failure. The EMPERIAL studies were initiated based on data obtained from the EMPA-REG OUTCOME® trial, in which Jardiance showed a 38% relative risk reduction in cardiovascular death and a 35% relative risk reduction in hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease, compared to placebo.
“The EMPERIAL trials highlight our commitment to listening to patients’ needs and studying the impact of our treatments on important measures such as quality of life,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for people with cardiorenal metabolic conditions, including adults with chronic heart failure.”
Full results from the EMPERIAL trials will be shared in 2020.
About EMPERIAL
EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks’ treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.
- EMPERIAL-preserved [NCT03448406]: investigated Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 315
- Completed: October 9, 2019
- EMPERIAL-reduced [NCT03448419]: investigated Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 312
- Completed: October 7, 2019
*Ejection fraction is a measurement expressed as a percentage of the amount of blood that leaves the heart each time it contracts, related to the total blood volume of the heart chambers. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.
HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.
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. It is a widespread condition affecting 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. Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S.
There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the U.S. and Europe.
About Cardiorenal Metabolic Conditions
Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. A team approach to optimize patient care by coordinating treatment of related comorbidities, including the use of emerging therapies with broad cardiorenal metabolic effects, may improve outcomes for people with serious chronic conditions such as these.
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).
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 to help those living with heart failure or chronic kidney disease.
Currently, no Boehringer Ingelheim and Lilly products are approved for the treatment of heart failure or chronic kidney disease.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients’ lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.
In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 percent of net sales.
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 Diabetes
Lilly 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 and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly 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.
SOURCE: Eli Lilly
Post Views: 167
