BOEHRINGER-INGELHEIM
6.11.2021 09:04:10 CET | Business Wire | Press release
Empagliflozin reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40 percent regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved® Phase III trial.1 In EMPEROR-Preserved® , two thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50 percent) and one third had mildly reduced LVEF (greater than 40 percent but less than 50 percent).2 The results were presented today at the American Society of Nephrology Kidney Week 2021, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211106005123/en/
“Heart failure and chronic kidney disease are intimately linked — the risk of death in people with heart failure increases with kidney function decline,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program Clinical Investigator and Emeritus Professor of Therapeutics and Cardiology at the University of Lorraine, France. “The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for both patients and physicians. The findings underscore the potential value of empagliflozin across a wide range of kidney function in this heart failure population that includes people with preserved ejection fraction.”
Nearly half of adults with heart failure also have chronic kidney disease.3 Together, these conditions are associated with high mortality rates and risk for hospital admission.3 More than 60 million people worldwide have heart failure, and approximately half of them have HFpEF.4,5 No currently approved treatments have been clinically proven to significantly improve outcomes across the full spectrum of heart failure.
“In those living with heart failure, including those with preserved ejection fraction, chronic kidney disease poses an additional challenge to managing these patients and contributes to the worsening and progression of heart failure,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “It is very encouraging to see the evidence from EMPEROR-Preserved® , which shows cardiovascular and kidney benefits in these patients with heart failure, including those with HFpEF, and concomitant chronic kidney disease.”
As previously reported, EMPEROR-Preserved® showed that empagliflozin significantly reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF over 40 percent compared with placebo.2 Empagliflozin also significantly reduced the risk of first and recurrent hospitalizations for heart failure and slowed kidney function decline.2
Over half (53.5 percent) of adults in EMPEROR-Preserved® had chronic kidney disease (defined as eGFR below 60 mL/min/1.73 m2 or UACR above 300 mg/g) at trial entry, and 9.7 percent had severe kidney impairment (eGFR below 30 mL/min/1.73 m2 ).1 The new prespecified sub-analysis of EMPEROR-Preserved® demonstrated that the benefits seen in the overall population were consistent in adults with and without chronic kidney disease.1 Empagliflozin consistently improved cardiovascular outcomes and slowed kidney function decline across the full range of kidney function down to an eGFR of 20 mL/min/1.73 m2 .1 Empagliflozin was well tolerated regardless of the level of baseline kidney function.1
“This data marks an important milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom are in need of additional treatment options for these interconnected, complex conditions,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We look forward to continuing research with the goal of addressing the unmet needs of those with kidney impairment, including through our EMPA-KIDNEY Phase III trial of empagliflozin, from which we eagerly await a readout next year.”
Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.6,7,8 Additionally, empagliflozin is approved for the treatment of adults with heart failure with reduced ejection fraction in the European Union and the U.S..6,7 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.9 Empagliflozin is also currently being investigated in chronic kidney disease.10
# Ends #
About the EMPEROR heart failure studies 11,12
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 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.13 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 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 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.14 To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.15 It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.4,5 Heart failure is highly prevalent in people with diabetes;16 however, more than half of all people with heart failure do not have diabetes.17
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.18 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.18
- 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.18
People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.19 Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.20
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.5,13
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.21,22,23
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.6,7,8
Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/emperor-preserved-kidney-subanalysis
View source version on businesswire.com: https://www.businesswire.com/news/home/20211106005123/en/
About Business Wire
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
AI: The New Insider Threat Facing Organizations25.2.2026 09:00:00 CET | Press release
Thales 2026 Data Threat Report Finds 70% of Organizations Rank AI as Top Data Security Risk As AI systems gain broader access to enterprise data across environments, organizations must treat data visibility and encryption as core security elements. AI-enabled deepfakes and misinformation are increasing the effectiveness of identity-based attacks. Today, credential theft is the leading attack technique against cloud infrastructure (67%). Nearly 60% of companies report deepfake-driven incidents, and 48% experience damage from AI-generated misinformation Investment in AI security is growing, with 30% of companies allocating dedicated budgets; however, 53% are still relying on existing security budget According to the Thales 2026 Data Threat Report, organizations across various markets including automotive, energy, finance and retail say the rapid pace of AI-driven transformation is now their biggest security challenge. Based on the report’s research, conducted by S&P Global 451 Research,
Zuper and Vonage Reimagine Network Connectivity for Skilled Trades with Quality on Demand25.2.2026 09:00:00 CET | Press release
Zuper to receive early access to Vonage Quality on Demand network API, for high-stakes field workflows - ensuring reliable network performance for live video, wearables, and inspections across industries like HVAC, electrical, general construction, roofing, manufacturing, and more Zuper, the AI operating system for the trades, and Vonage, part of Ericsson, have entered into a Memorandum of Understanding (MoU) to enter into a collaboration to integrate Vonage’s network APIs into the Zuper platform. The collaboration will provide Zuper with early access to Vonage network powered solutions, starting with Quality on Demand (QoD), where mobile network performance can be selectively applied to support critical field workflows, delivering improved latency, reliability, and connected experiences for mobile workforces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260225852261/en/ QoD is the first advanced network API being integrat
Industrial Decarbonization: Calderion, WenCo and Terravent Invest in Graforce to Scale Plasma Pyrolysis Globally25.2.2026 08:07:00 CET | Press release
The investor consortium comprising the Paris-based Next Generation Fuels Industrial & Technological fund Calderion (Audacia), alongside infrastructure developer Terravent and WenCo Family Office, announces the closing of a strategic double-digit million-euro financing round for Berlin-based Graforce GmbH. The investment is dedicated to the industrial scale-up of Graforce’s proprietary plasma pyrolysis technology, addressing the growing global demand for cost-efficient low-carbon hydrogen, syngas, and carbon removal solutions that are compatible with existing industrial infrastructures. Disruptive alternative to conventional processes Graforce’s technology aims at replacing CO₂-intensive legacy routes such as steam reforming and classical gasification. By applying plasma to methane, biogas, flare gas, and landfill gas, the process converts these streams into their valuable molecular components instead of emitting them. The result is a high-efficiency production of clean hydrogen and syn
Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy25.2.2026 08:00:00 CET | Press release
CE Marking enables marketing and clinical use of the world’s first and only LINAC vault-ready proton therapy system across the European Union Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has received CE Marking under Regulation (EU) 2017/745 (EU MDR). This regulatory milestone enables the marketing, sale, and clinical use of the MEVION S250-FIT system throughout the European Union, building on the system’s existing U.S. FDA 510(k) clearance granted in September 2025. The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION S250-FIT dramatically reduces the cost, complexity, and timeline traditionally associated with proton therapy adoption. This opens a new pathway for hospitals and cancer centers a
Bureau Veritas:Sector-Leading Organic Revenue Growth of 6.5% in FY 202525.2.2026 07:30:00 CET | Press release
Strong margin improvement to 16.3% in FY 2025Positive growth outlook with continued margin expansion in 2026New EUR 200 million share buyback Bureau Veritas (BOURSE:BVI): 2025 key figures1 › Full-year revenue of EUR 6,466.4 million, up 6.5% organically (with 6.3% organic growth in Q4). At constant currency, the growth was up 7.3% year-on-year and up 3.6% on a reported basis, › Adjusted operating profit of EUR 1,052.9 million, up 5.7% versus EUR 996.2 million in FY 2024, representing an adjusted operating margin of 16.3%, up 32 basis points year-on-year and up 51 basis points at constant currency, › Operating profit of EUR 992.4 million, up 6.3% versus EUR 933.4 million in FY 2024, › Adjusted net profit of EUR 631.4 million, up 1.7% versus EUR 620.7 million in FY 2024, › Adjusted EPS stood at EUR 1.42 in 2025, with a 2.8% increase versus FY 2024 (EUR 1.38 per share) and up 9.2% at constant currency, › Attributable net profit of EUR 588.0 million, up 3.3% versus EUR 569.4 million in FY 2
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