Ingelheim, Germany, and Indianapolis, US, 11 November 2019 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the initiation of EMPULSE, the sixth Phase III study in the empagliflozin heart failure programme. The study will assess whether in-hospital administration of empagliflozin 10 mg daily improves heart failure outcomes when initiated in people hospitalised for any type of acute heart failure event once they have been stabilised. The study will include participants both with and without type 2 diabetes.
Heart failure is the leading cause of hospitalisation in Europe and the US, and half of people with heart failure are expected to die within five years of diagnosis.2,3 However, outcomes for patients after they have been hospitalised for heart failure are poor, with a 15 percent mortality and 30 percent readmission rate within 60 to 90 days of discharge from hospital.4 Initiating treatment in hospital is one of the best predictors of long-term improved prognosis and patient treatment adherence.5 The EMPULSE study aims to understand whether empagliflozin has the potential to improve outcomes in this population.
“Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalisation. Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure,” said Adriaan Voors, Professor of Cardiology, University Medical Center Groningen, Netherlands. “The beneficial effects of SGLT2 inhibitors, as seen in three large randomised trials in type 2 diabetes patients, are thought to be at least partly explained by the diuretic/natriuretic effects of SGLT2 inhibitors. The EMPULSE study will investigate whether empagliflozin, due to its mode of action, can alleviate symptoms associated with heart failure and improve outcomes after discharge from the hospital.”
The primary outcome of the study will be net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalisations, urgent heart failure visits and unplanned patient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS), an instrument for measuring disease-specific quality of life in heart failure.1
“We are particularly delighted to announce the addition of EMPULSE as the first-ever study to assess the effects of empagliflozin in people who have been hospitalised for acute heart failure,” 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 study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure programme.”
EMPULSE is part of the empagliflozin heart failure programme, which also consists of the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies. These studies are investigating the effects of empagliflozin on heart failure-related outcomes and functional capacity in more than 9,500 adults with heart failure, including those with and without diabetes.6,7,8,9,10
About EMPULSE (NCT04157751)
The EMPULSE study is a multicentre, randomised, double-blind, 90-day superiority study to evaluate the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd (EMPULSE).
- Primary endpoint: Net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalisations for heart failure, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 90 days of treatment.
- Anticipated number of patients: approximately 500.
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.11 It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.12 Heart failure is highly prevalent in people with diabetes;13 however, approximately half of all people with heart failure do not have diabetes.2,14
Symptoms of heart failure include difficulty breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others.15 People with heart failure experience a substantial reduction in quality of life, approximately 76 percent of whom find it difficult to carry out usual activities.16 This is, in part, due to the limitation of physical activity.
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.17 Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the US and Europe.2
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 the label in several countries.18,19,20
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.21
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 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.
Boehringer Ingelheim
Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.
Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 percent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
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 programmes 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.
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 chronic kidney disease and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialisation. 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.
CONTACT:
Stefanie Dölz
Product Communication Manager
Boehringer Ingelheim
Phone: +49 (6132) 77-172209
Stephan Thalen
Global Business Communications
Lilly Diabetes
Phone: +1 (317) 276 8304
