Ingelheim, Germany and Indianapolis, US, 30 July 2020 – Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced today by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY). EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10 mg) compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. Overall, the safety profile was similar to the known safety profile of empagliflozin.
“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” 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, Texas, US. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
Heart failure is the leading cause of hospitalization in the US and Europe, and the number of patients across Asia is also increasing.2 The risk of death in people with heart failure rises with each hospital admission.3 Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.4 Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.5
“One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are excited to share the full results and are working tirelessly to explore how empagliflozin can improve the lives of people living with heart failure.”
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020 on 29 August, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction – an area with no approved treatment options.6,7 EMPEROR Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
“These results build upon the already established cardiovascular benefits of empagliflozin in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how empagliflozin can help adults around the world living with these conditions.”
About the EMPEROR Heart Failure Studies6,8
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with chronic heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
- EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF)
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
About the EMPOWER program
The Alliance has developed the EMPOWER program to explore the impact of empagliflozin 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.9 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 nine clinical trials and a real-world evidence study, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 27,000 adults enrolled worldwide in clinical trials, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.
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.10 It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.11 Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.11,13
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.14
About Cardio-Renal-Metabolic Conditions
Boehringer 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.9
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.15,16
Through our research and treatments, our goal is to support people’s health, restoring the balance 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.
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.17,18,19
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.20
About 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. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease.
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, 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 19 billion euros. Our significant investment of almost 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.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to 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
http://www.lilly.com/ and
https://newsroom.lilly.com/social-channels.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about clinical trials to evaluate empagliflozin as a treatment for adults with heart failure and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of 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 empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
CONTACTS:
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Phone: +49 (6132) 77 172209
Stephan Thalen
Global Business Communications
Lilly Diabetes
Phone: +1 (317) 276 8304
Footnotes
- *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.
- HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
- HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
References
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3 Solomon S, Dobson J, Pocock S, et al. Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure. Circulation. 2007;116(13):1482–7.
4 American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement. Accessed July 2020.
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18 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
19 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
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