Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance® (empagliflozin) following stabilization and prior to discharge compared with placebo in the phase III EMPULSE trial, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.
RIDGEFIELD, Conn. and INDIANAPOLIS, March 1, 2022 /PRNewswire/ -- Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance® (empagliflozin) following stabilization and prior to discharge compared with placebo in the phase III EMPULSE trial, Boehringer Ingelheim and Eli Lilly and Company(NYSE: LLY) announced today. Clinical benefit reflected a composite primary endpoint that included all-cause mortality, frequency of heart failure events, time to first heart failure event and symptoms as measured by the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS). The findings were published in Nature Medicine and presented at the American Heart Association’s Late-Breaking Scientific Sessions 2021. “The first months following hospitalization for heart failure are a particularly vulnerable time for patients,” said Adriaan Voors, Professor of Cardiology, University Medical Center, Groningen, Netherlands, and EMPULSE principal investigator. “Current outcomes are poor, underscoring the urgent need for improved in-patient clinical management to prevent further hospitalizations or death. This significant clinical benefit with empagliflozin compared with placebo will advance our understanding of the treatment of heart failure during the early discharge phase.” Heart failure is a leading cause of hospitalizations, accounting for more than 1 million per year in the U.S. Outcomes for those who have been admitted to the hospital for heart failure are poor, with over 30% of patients readmitted within 90 days between 2010 and 2017, according to the National Readmission Database. The overall clinical benefit with Jardiance was consistent for those with either new or pre-existing heart failure, for those with or without diabetes and for those with either preserved or reduced ejection fraction. In an exploratory secondary endpoint, Jardiance significantly improved KCCQ-TSS from baseline to day 90 by 4.5 points versus placebo. The EMPULSE safety results were consistent with the well-established safety profile of Jardiance. Investigator-reported acute renal failure rates were 7.7% for Jardiance versus 12.1% for placebo, and there was a similar low incidence of hypoglycemia in both groups (1.9% for Jardiance vs. 1.5% for placebo). Volume depletion rates were 12.7% versus 10.2%, respectively. “We are encouraged by the early and significant clinical benefit seen in EMPULSE with Jardiance when initiated in adults with heart failure with either preserved or reduced ejection fraction prior to hospital discharge, including improvements in an endpoint combining mortality, hospitalizations and quality of life,” 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. “We remain committed to trials such as this that help us better understand how this therapy may benefit people with a range of cardio-renal-metabolic conditions for whom additional treatment options are greatly needed.” “The EMPULSE results add to the growing weight of evidence from our EMPOWER program supporting the potential role of Jardiance in a range of conditions affecting the heart, kidneys and metabolic system,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “The clinical benefit and consistent safety results demonstrated in the vulnerable phase following hospital discharge suggest that in-hospital initiation with Jardiance for appropriate patients can improve outcomes during these critical months.” Recently, the U.S. Food and Drug Administration (FDA) approved Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure based on data from the EMPEROR-Preserved® trial. This decision marks the third U.S. FDA approval for Jardiance stemming from the EMPOWER program. About EMPULSE The win ratio estimates the odds that a participant in the Jardiance arm will have a better clinical benefit than a participant in the placebo group; higher win ratios suggest a greater clinical benefit with Jardiance. For EMPULSE, patients were stratified by de novo versus decompensated chronic heart failure. Within each stratum, every individual in the Jardiance group was compared with every individual in the placebo group. The win ratio was determined by the total number of wins for Jardiance divided by the total number of losses. The components of the primary endpoint were evaluated in order of clinical importance, so that deaths are prioritized over heart failure events and symptoms. About the EMPOWER program The development program encompasses:
About Heart Failure Prioritizing Cardio-Renal-Metabolic Care
The cardiovascular, renal (kidney) and metabolic systems are closely intertwined and share many of the same disease-related pathways. Dysfunction in one system may accelerate the onset of dysfunction in others, resulting in the progression of comorbid diseases such as type 2 diabetes, heart failure and chronic kidney disease. Conversely, improving the health of one system can lead to positive effects across the others and can help reduce the risk for further complications. Understanding their interconnected nature, we are working to advance treatments that can protect the organs of the cardio-renal-metabolic systems. It is only through a holistic approach to care that we can truly transform outcomes and restore the harmony between these critical systems. What is JARDIANCE? JARDIANCE is a prescription medicine used to:
JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine). JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work. IMPORTANT SAFETY INFORMATION Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Do not take JARDIANCE if you are on dialysis. JARDIANCE can cause serious side effects, including:
Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
If you have any of these symptoms, stop taking JARDIANCE and contact your healthcare provider or go to the nearest emergency room right away. The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist. Before taking JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, please see Prescribing Information and Medication Guide. CL-JAR-100113 02.28.2022 Boehringer Ingelheim and Eli Lilly and Company About Boehringer Ingelheim As a world-leading, research-driven pharmaceutical company, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020, Boehringer Ingelheim achieved net sales of around 22.33 billion USD (19.57 billion EUR). Our significant investment of over 4.2 billion USD (3.7 billion EUR) in 2020 (18.9% of net sales) 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. Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA. Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. About Lilly Diabetes About Eli Lilly and Company This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance as a treatment for adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction, and as a potential treatment for adults with cardio-renal-metabolic conditions and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. Jardiance®, EMPEROR-Reduced®, EMPEROR-Preserved® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim. P-LLY CONTACT: Stephan Thalen
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