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 studies
15,16
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.
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.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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210827005316/en/
Contact information
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172 209
Anna Bergmann
Global Business Communications
Eli Lilly and Company
Email: anna.bergmann@lilly.com
Phone: +1 317 864 3143
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Westlake Announces Proposed Offering of Senior Notes4.11.2025 16:15:00 EET | Press release
Westlake Corporation (NYSE: WLK) (“Westlake”) announced today the commencement of an underwritten public offering, subject to market and other conditions, of senior unsecured notes (the “Notes”) under its existing shelf registration statement. The timing of pricing and terms of the Notes are subject to market conditions and other factors. Westlake intends to use the net proceeds from the proposed public offering of the Notes to fund the repurchase of its outstanding 3.600% Senior Notes due 2026 (the “2026 Senior Notes”) pursuant to a concurrent cash tender offer (the “Tender Offer”) for any and all of the 2026 Senior Notes. Westlake anticipates using any remaining net proceeds to fund the purchase price of its pending acquisition of the global compounding solutions businesses of the ACI/Perplastic Group (the “ACI Acquisition”) and for general corporate purposes, including working capital management. The offering of the Notes is not contingent upon the successful completion of the Tende
Westlake Announces Cash Tender Offer4.11.2025 16:13:00 EET | Press release
Westlake Corporation (NYSE: WLK) (“Westlake”) announced today the commencement of a cash tender offer to purchase (the “Offer”) any and all of the outstanding 3.600% Senior Notes due 2026 (the “Notes”) as set forth in the table below. The tender offer is being made solely pursuant to the terms and conditions set forth in an Offer to Purchase, dated November 4, 2025 (the “Offer to Purchase”). Holders of the Notes are urged to carefully read the Offer to Purchase before making any decision with respect to the tender offer. The tender offer is not conditioned on any minimum amount of the Notes being tendered. Subject to applicable law, Westlake may amend, extend or terminate the tender offer in its sole discretion. Capitalized terms used but not defined in this announcement have the meanings given to them in the Offer to Purchase. Series of Notes CUSIP Numbers(1) Aggregate Principal Amount Outstanding U.S. Treasury Reference Security(2) Bloomberg Reference Page(2) Fixed Spread(3) 3.600% S
In-House Counsel Warn of Mounting Risks as Service of Process Volume Surges4.11.2025 16:00:00 EET | Press release
The volume of service of process (SOP)—the legal procedure by which one party formally notifies another of a legal action—is surging across the U.S., amplifying operational pressure and compliance risk for in-house legal teams. This is according to a new nationwide study commissioned by CSC, industry-leading registered agent and compliance service provider. CSC surveyed 250 senior in-house counsel across the U.S. and found that rising SOP volume and growing concerns around data accuracy are intensifying both risk and workload pressure.1 Respondents cited data accuracy as a significant challenge to SOP management (61%), followed by rising SOP volume (56%). More than three-quarters (76%) said their departments are spending “too much” or “excessive” time managing SOP, underscoring the growing operational demands placed on legal teams. The rising complexity of SOP, driven by new and differing state rules is increasing compliance exposure. Most respondents (59%) indicated that managing SOP
ITRS Named a Visionary in 2025 Gartner® Magic Quadrant™ for Digital Experience Monitoring for Second Consecutive Year4.11.2025 16:00:00 EET | Press release
ITRS today announced it has been named a Visionary in the 2025 Gartner® Magic Quadrant™ for Digital Experience Monitoring (DEM) for the second year in a row. ITRS is a pioneer in real-time monitoring and observability for mission-critical industries. Uptrends, its DEM solution, enables customers to deliver reliable, high-performing digital experiences across regulated and globally distributed environments. “We’re deeply committed to our clients’ success and proud to be named a Visionary for the second year in a row,” commented Ryan Terpstra, CEO of ITRS. “Digital Experience Monitoring connects IT system health to end-user satisfaction — empowering our clients to deliver world-class digital products that build loyalty, strengthen trust, and drive business growth.” Reducing Complexity, Enriching Observability: Agentic AI-Enabled DEM ITRS is infusing agentic AI into its DEM platform to enable customers to deploy holistic monitoring and adapt faster at enterprise scale. This minimizes the
Mobile Developers Enter a New Era of Platform Freedom With the Latest Updates to Xsolla Web Shop and Buy Button4.11.2025 16:00:00 EET | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, announces new features and capabilities to the industry-leading web shop solution. Arriving as the U.S. market moves toward a new open era for external payments, new enhancements to the Xsolla Web Shop and Buy Button provide developers with the tools to drive higher margins and more player engagement across iOS and Android. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251104283284/en/ (Graphic: Xsolla) The U.S. is now leading the push for more open app ecosystems, with similar moves in the UK, Europe, Japan, Brazil, and beyond to allow external payments. The Xsolla Web Shop enables studios to embrace this shift, increasing margins on every transaction as monetization options expand beyond app stores. Key benefits of the new plug-in features in Xsolla Web Shop include: Unlock higher margins via seamless purchases with
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom