October 10, 2018
Today, the journal Circulation published novel results based on data from the landmark EMPA-REG OUTCOME® trial, which suggest that treatment with empagliflozin positively impacts life expectancy in adults with type 2 diabetes and established cardiovascular disease. Using actuarial methods*, and assuming that the demonstrated beneficial effects of empagliflozin remain consistent with long-term use, empagliflozin was estimated to extend life expectancy by 1 to 4.5 years on average, depending on age, when compared with placebo.1 This analysis suggests that treatment with empagliflozin could add years of life.
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In an analysis of data from 7,020 patients included in the EMPA-REG OUTCOME® trial, estimated life expectancy increased across all ages when adults were treated with empagliflozin as compared to those treated with placebo. Specifically, estimated mean survival in people aged 45 years was 32.1 years with empagliflozin versus 27.6 years with placebo, resulting in a mean survival difference of 4.5 years. In people aged 50, 60, 70 and 80 years old, the mean survival difference with empagliflozin compared to placebo was an additional 3.1 years, 2.5 years, 2 years and 1 year, respectively.1
The primary EMPA-REG OUTCOME® trial results, published in the New England Journal of Medicine in September 2015, demonstrated a 38 percent relative risk reduction in cardiovascular death and a 32 percent relative risk reduction in all-cause mortality with empagliflozin in people with type 2 diabetes and established cardiovascular disease, compared with placebo, over a period of 3.1 years.2 Modelling based on the EMPA-REG OUTCOME® trial data was used to quantify the potential benefit of empagliflozin on residual life span.
*Actuarial methods refer to the statistical techniques and analysis used to prepare mortality and other analytical tables
“For a 60-year-old living with type 2 diabetes, who has already had a cardiovascular event, previous studies estimate that life expectancy could be reduced by up to 12 years compared with someone of the same age without these conditions,” commented Brian Claggett, Ph.D., Division of Cardiovascular Medicine, Brigham and Women’s Hospital and lead author of the Circulation paper. “This latest analysis estimates that empagliflozin could prolong such a person’s life span by, on average, 2.5 years.”
About Diabetes and Cardiovascular Disease
More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.3 By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.3 Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries.3 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.3
Due to the 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.4,5 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.5 In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.3 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.6,7
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 at age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.8
The American Diabetes Association and Diabetes Canada recommend the use of agents that have been proven to reduce the risk of cardiovascular events for patients with type 2 diabetes and established cardiovascular disease (such as empagliflozin).9,10
About the EMPA-REG OUTCOME trial®2
The EMPA-REG OUTCOME® trial was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 people from 42 countries with type 2 diabetes at high risk for cardiovascular events.
The trial 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.
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.11,12,13
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.
Empagliflozin is not approved for people with type 1 diabetes.
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres 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.
About Boehringer Ingelheim
Improving the health and quality of life of patients 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 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent 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.
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 programs 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 healthcare leader that unites caring with discovery to 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 www.lilly.com and newsroom.lilly.com/social-channels.
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 empagliflozin and its safety profile, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that JARDIANCE 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.
1 Claggett B, et al. Long-Term Benefit of Empagliflozin on Life Expectancy in Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease. Circulation. 2018;138:1599-1601.
2 Zinman B. et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-2128.
3 International Diabetes Foundation. Diabetes Atlas 8th Edition. Available at: http://www.diabetesatlas.org. Accessed: March 2018.
4 World Health Organisation. Diabetes: Fact Sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Last accessed March 2018.
5 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. Last accessed March 2018.
6 Morrish NJ et al. Mortality and Causes of Death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(2):S14–21.9.
7 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.
8 The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.
9 American Diabetes Association. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes – 2018. Diabetes Care. 2018;41[Suppl.1]:S86-S104.
10 Diabetes Canada Clinical Practice Guidelines Expert Committee. Diabetes Canada 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2018;42(Suppl 1):S1-S325.
11 Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Last accessed August 2018.
12 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
13 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.