Landmark trial demonstrates empagliflozin is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction
Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed an impressive 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo.1 The benefit was independent of ejection fraction or diabetes status,1 establishing empagliflozin as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients. The results were presented today at the European Society of Cardiology (ESC) Congress 20212 and published in The New England Journal of Medicine,1 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210827005316/en/
Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent and significantly slowed kidney function decline.1
“For people with heart failure with preserved ejection fraction, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition,” said Professor Stefan Anker, EMPEROR-Preserved Principal Investigator and Heart Failure Cardiologist at Charité Berlin, Germany. “This data brings hope for millions of patients suffering from heart failure with a preserved ejection fraction. The primary endpoint was similarly improved in all subgroups of patients, in men and women, with and without diabetes, and regardless of their ejection fraction and kidney function level. This underlines the breadth of empagliflozin’s efficacy and its potential overall impact.”
More than 60 million people worldwide have heart failure and approximately half of them have HFpEF, which is also known as diastolic heart failure.3,4 HFpEF has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the absence of clinically proven therapies to date.5,6
EMPEROR-Preserved included 5,988 people with heart failure.1 Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50 percent or above and 1,983 had a LVEF below 50 percent.1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.1 The overall safety data was consistent with previous findings, confirming the well-established safety profile of empagliflozin.7
“Heart failure is a complex, serious health issue and a leading cause of hospitalization,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “The risk of death in people with heart failure rises with each hospital admission and with kidney function decline. The landmark EMPEROR-Preserved trial shows that empagliflozin brings significant benefit, which is incredibly exciting and welcome news for both the medical and patient communities.”
“These impressive results will bring hope for the millions of people who currently have limited therapeutic options for a very serious, life-threatening condition,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Now there is a light at the end of the tunnel. If approved, empagliflozin would become the first clinically proven therapy across the full heart failure spectrum. The results of EMPEROR-Preserved offer an opportunity to fundamentally change the future for people with heart failure.”
The benefits demonstrated in the EMPEROR-Preserved trial are similar to those in the EMPEROR-Reduced trial, in which empagliflozin significantly reduced the relative risk of the composite endpoint of cardiovascular death or hospitalization for heart failure by 25 percent, compared with placebo, in adults with heart failure with reduced ejection fraction (HFrEF).8 Together, these studies demonstrate the benefits of empagliflozin for patients across the full heart failure spectrum.
Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.9,10,11 Additionally, empagliflozin is approved for the treatment of adults with HFrEF in the European Union and the U.S.9,12 Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of empagliflozin on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure.13 Empagliflozin is also currently being investigated in chronic kidney disease.14
# Ends #
About the EMPEROR heart failure studies15,16
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies were two Phase III, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes:
- EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic 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] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF.
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 5,988
- Completion: 2021
- Link to lay summary
About the EMPOWER program
The Boehringer Ingelheim and Lilly 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.17 Through the EMPOWER program, the Alliance is working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine 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 400,000 adults enrolled worldwide in clinical studies, 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.18 To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.19 It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.3,4 Heart failure is highly prevalent in people with diabetes;20 however, more than half of all people with heart failure do not have diabetes.21
There are different types of heart failure. People with left-sided heart failure have either a reduced or a preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction.22 When the heart relaxes, the ventricle refills with blood.
- Heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out to the body.22
- Heart failure with reduced ejection fraction occurs when the left ventricle of the heart is not able to contract effectively, which means that the heart cannot pump with enough force, so less blood is pushed out to the body.22
People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.23 Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.24
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.4,17
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, improvements in one system can lead to positive effects throughout the others.25,26,27
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.
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.9,10,11
Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/emperor-preserved-heart-failure-full-data
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Product Communication Manager
Phone: +49 (6132) 77 172 209
Global Business Communications
Eli Lilly and Company
Phone: +1 317 864 3143
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
i2c Outlines Key Growth Opportunities for UK and Europe22.9.2021 12:12:00 CEST | Press release
i2c Inc., a leading provider of digital payment and banking technology, today disclosed what it sees as key opportunities for growth in the UK and European markets, highlighting digital first, B2B commercial payments, cryptocurrency and credit as high-demand areas in which it is favorably positioned to compete. “In the past 18 months, we’ve seen increased opportunities as well as validation and acceptance of our offering in initiatives where these criteria and related use cases play heavily to customers’ requirements,” said Jonathan Vaux, general manager for UK and EU at i2c. He also noted that the driving forces appear to be a combination of continued bank digitization, a surge in payments and financial innovation in the commercial space, heightened competition among crypto players to achieve faster innovation cycles and market expansion, and broad interest in reconstructing credit as an embedded feature. According to the company, its platform features distinct characteristics that UK
TransferMate Global Payments Selects ComplyAdvantage For The Company’s Award-Winning AML And Risk Screening Solutions22.9.2021 10:57:00 CEST | Press release
Today ComplyAdvantage, a global data technology company transforming financial crime detection announced that TransferMate Global Payments, a leading global B2B-payments technology solution provider, has selected the reg tech innovator’s award-winning customer onboarding, transaction screening and monitoring solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005398/en/ Charles Delingpole, CEO of ComplyAdvantage (Photo: Business Wire) Headquartered out of Kilkenny, Ireland, TransferMate is a subsidiary of Clune Technology Group founded by Terry Clune and is a leading global B2B payments technology firm enabling companies to send and receive cross-border payments faster and easier. Now more than ever before, fast growing enterprises like TransferMate are implementing the best technologies and processes not only to reduce their risk profile as it relates to financial crimes but also to help accelerate service expan
Investable Universe Launches Provocative Polar Futures Media Series22.9.2021 10:15:00 CEST | Press release
The real assets news site Investable Universe announces the launch of Polar Futures, a media series that examines the eight-nation Arctic region’s growing geopolitical importance and its potential for attracting hundreds of billions of dollars in direct investment to develop the region and its bounty of natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005180/en/ Institutional investors, pension funds and other investors are eyeing the potential of developing infrastructure, shipping, logistics, telecommunications, mining, aquaculture and marine resources and of incubating technologies that aid the transition to renewable energy. Additionally, new trans-Arctic shipping lanes made more accessible by climate change will focus competing political and military interests on the polar zone. Nuanced insights from pivotal figures Against this fluid strategic backdrop, the weekly newsletter and podcast series, c
Aqara Introduces Smart Roller Blind Retrofit Solution22.9.2021 10:00:00 CEST | Press release
Aqara, a provider for smart home products, announced the launch of the Aqara Roller Shade Driver E1, a retrofit roller shade controller to automate the existing beaded chain roller shades. The roller shade driver fits beaded cord roller shades with the bead thickness of 3 - 6 millimeter, and works with both plastic and metal beads. The driver has been available on Amazon UK starting from September 22, 2021, and it is expected to land on Amazon France in the next few weeks. It will also be made available via authorized Aqara retailers in Europe and Asia in the following months. Shades are necessary for almost all homes, as they block harmful UV rays, save energy (for ACs and lights) and protect privacy. Automated shades save users the trouble of manually controlling the shades day in and day out, while helping to cut energy bills and enhance indoor comfort. The Roller Shade Driver E1 provides a quick, easy and cost-effective way to automate the existing roller blinds. The installation i
Flawed: Cayman Finance Challenges Credibility Of Tax Justice Network’s Biannual Financial Secrecy Index22.9.2021 09:10:00 CEST | Press release
Cayman Finance has today released a new study that critically assesses the methodology and data used to assess the Cayman Islands in Tax Justice Network’s (TJN) ‘Financial Secrecy Index’ (FSI). Significant flaws in TJN’s choice of data and scoring have rendered the 2020 report an unreliable source for accurate information about the Cayman Islands financial services industry. Future TJN reports’ will also lack credibility without critical changes in the application of their own methodology – and Cayman Finance will continue to scrutinise and analyse future editions to ensure continued accountability. Ahead of the anticipated publication of the other TJN reports this fall, Cayman Finance commissioned the review to analyse the calculations of the previous report published in 2020, which incorrectly placed the Cayman Islands first globally in its secrecy ranking. This analysis, by accomplished economist Julian Morris, identified significant flaws in how TJN applied its own original methodo
Forty Leading Organizations, Including 11 of the 20 Largest Dairy Companies in the World, Among First to Support New Global “Pathways to Dairy Net Zero” Climate Initiative22.9.2021 09:00:00 CEST | Press release
Pathways to Dairy Net Zero, a ground-breaking new climate initiative, is launching today during Climate Week and just prior to the United Nations (UN) Food Systems Summit. Forty leading organizations, including 11 of the 20 largest dairy companies in the world, have already declared their support for the effort. Collectively, these supporters represent approximately 30 percent of total milk production worldwide. The new climate initiative demonstrates the global dairy sector’s commitment to reducing GHG emissions while continuing to produce nutritious foods for six billion people and provide for the livelihoods of one billion people. “Pathways to Dairy Net Zero will accelerate climate efforts already underway and drive further necessary action to reduce dairy’s emissions over the next decades. The dairy sector has a lot to offer to lead this transition,” said Hein Schumacher, Chief Executive Officer of Royal FrieslandCampina and Chairman of Global Dairy Platform. “Mengniu is proud to j
Hughes and SES Demonstrate First Multi-Orbit SATCOM for Remotely Piloted Aircraft22.9.2021 08:50:00 CEST | Press release
Hughes Network Systems, LLC (HUGHES) and SES today announced the successful first demonstration of a new multi-orbit satellite communications (SATCOM) capability for remotely piloted aircraft. Conducted for General Atomics Aeronautical Systems, Inc. (GA-ASI), the demonstration paired Hughes HM series software-defined modems and Resource Management System (RMS) with SES’s satellites that operate in geosynchronous (GEO) and medium earth (MEO) orbits. SES’s unique multi-orbit fleet, which delivers global coverage, high throughput and security, was leveraged to show how unmanned aerial vehicles, such as the GA-ASI MQ-9 series, can maintain crucial connectivity and resiliency, even in contested environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921006196/en/ Hughes and SES Demonstrate First Multi-Orbit SATCOM for Remotely Piloted Aircraft (Photo: Business Wire) The demonstration replicated a typical unmanned Intellig