Consistent cardiovascular benefits shown with empagliflozin treatment regardless of the number of controlled cardiovascular risk factors
- Post-hoc analysis of the EMPA-REG OUTCOME® trial in adults with type 2 diabetes and established cardiovascular disease examined the cardiovascular benefits of empagliflozin based on the number of cardiovascular risk factor goals achieved.1
- Findings from the post-hoc analysis were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes.1
- This analysis suggests that, independent of the number of risk factor goals achieved, empagliflozin demonstrated cardiovascular benefits (risk reduction in cardiovascular death, hospitalisation for heart failure and 3P-MACE) in patients with type 2 diabetes and cardiovascular disease that are consistent with primary outcomes from the EMPA-REG OUTCOME® trial.
Ingelheim, Germany, and Indianapolis, US, 19 September 2019 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results of a post-hoc analysis of the landmark EMPA-REG OUTCOME® trial that were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain. Results suggest that the risk reduction in cardiovascular events, including cardiovascular death and hospitalisation for heart failure, seen with empagliflozin in the EMPA-REG OUTCOME® trial in adults with type 2 diabetes and established cardiovascular disease, were not affected by the number of controlled cardiovascular risk factors.1
“Reducing cardiovascular risk in people with type 2 diabetes can be challenging, particularly in those with uncontrolled cardiovascular risk factors, such as blood sugar levels and blood pressure,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “It is therefore encouraging to see these findings from the EMPA-REG OUTCOME®trial in which empagliflozin was shown to improve cardiovascular outcomes in people with type 2 diabetes and cardiovascular disease, irrespective of whether cardiovascular risk factors were controlled.”
In this post-hoc analysis, the cardiovascular benefits of empagliflozin – including risk reduction for cardiovascular death and hospitalisation for heart failure – were investigated in subgroups of people with type 2 diabetes and established cardiovascular disease based on their cardiovascular risk factor goals. These cardiovascular risk factor goals were: blood sugar levels; cholesterol levels or statin use; blood pressure; presence of albumin in the urine; use of blood pressure medication; use of aspirin; and smoking status.1
In the EMPA-REG OUTCOME®trial, empagliflozin provided a 38 percent reduction in the risk of cardiovascular death (HR 0.62; 95% CI 0.49-0.77), a 35 percent reduction in the risk of hospitalisation for heart failure (HR 0.65; 95% CI 0.50-0.85) and a 14 percent reduction in the risk of 3P-MACE (HR 0.86; 95% CI 0.74-0.99), and this post-hoc analysis demonstrates that these cardiovascular benefits were not affected by the number of risk factor goals achieved.1
“Approximately half of all deaths in people with type 2 diabetes are caused by cardiovascular disease. Therefore, ensuring both patients and healthcare professionals understand the importance of cardioprotection remains an urgent priority,” said Sherry Martin, MD, Vice President, Global Medical Affairs, Lilly. “We are pleased to see that these results demonstrate that empagliflozin can help to address this unmet need by offering benefits to people with type 2 diabetes and cardiovascular disease across the spectrum of cardiovascular risk.”
Recent updates to more than 60 treatment guidelines worldwide now include findings from the EMPA-REG OUTCOME trial® as part of their endorsement of treatments with proven cardiovascular benefits for people with type 2 diabetes and established cardiovascular disease.2 Specifically, in the new 2019 ESC Guidelines on diabetes, pre-diabetes and cardiovascular disease – developed in collaboration with EASD – and an Expert Consensus Decision Pathway issued by the American College of Cardiology in 2018, empagliflozin is the recommended SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.3,4
About EMPA-REG OUTCOME® (NCT01131676)5
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.
The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.
The overall safety profile of empagliflozin was consistent with that of previous trials.
About Diabetes and Cardiovascular Disease
More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.6 By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.6 Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.6
Due to complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes.7,8 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.8 In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.6 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.9,10
Having a history of diabetes at age 60 can shorten a person’s life span by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke by age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.11
Worldwide, more than 60 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a Consensus Report initiated by the American Diabetes Association® and European Association for the Study of Diabetes, recommending that, in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, SGLT2 inhibitors (such as empagliflozin) or GLP1 receptor agonists with proven cardiovascular benefits are recommended as part of glycaemic management. 2,12
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.13,14,15
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces 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.
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.
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.
More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.
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:
Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
Stephan Thalen
Global Business Communications
Lilly Diabetes
Email: stephan.thalen@lilly.com
Phone: +1 (317) 276 8304
References
1 Inzucchi SE, Khunti K, Fitchett DH et al. 19-LB: Consistent cardiovascular (CV) benefits from empagliflozin across the spectrum of CV risk factor control: post hoc analysis from EMPA-REG OUTCOME. Diabetes 2019; 68(1).
2 Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
3 Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2019;00:1-69.
4 Das SR, Evertt BM, Birtcher KK, et al. 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2018;72(24):3200-23.
5 Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-28.
6 International Diabetes Foundation. Diabetes Atlas 8th Edition. Available at: https://diabetesatlas.org/resources/2017-atlas.html. Accessed: September 2019.
7 World Health Organisation. Diabetes: Fact Sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Accessed: September 2019.
8 World Heart Federation. Diabetes as a Risk Factor for Cardiovascular Disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes. Accessed: September 2019.
9 Einarson TR, Acs A, Ludwig C, et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007–2017. Cardiovasc Diabetol. 2018;17:83.
10 Morrish NJ, Wang SL, Stevens LK, et al. Mortality and Causes of Death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(2):S14-21.
11 The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.
12 Davies MJ, D’Alessio DA, Fradkin J, et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669-01.
13 Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: September 2019.
14 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
15 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.