New analysis estimates the positive impact of empagliflozin on prolonging life expectancy in adults with type 2 diabetes and established cardiovascular disease

Survival estimates from the EMPA-REG OUTCOME^® trial data demonstrate potential long-term benefit of empagliflozin on life expectancy of adults with type 2 diabetes and cardiovascular disease¹

BURLINGTON, ON and TORONTO, Nov. 6, 2018 /CNW/ - 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.²

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.³

"Studies show that people with diabetes develop heart disease up to 15 years earlier and have more heart failure than individuals without diabetes. This results in a substantial reduction of life expectancy in patients with diabetes especially when they have heart disease," says Dr. David Fitchett, cardiologist at St Michael's Hospital in Toronto, and a coauthor of the Circulation paper. "Our research indicates empagliflozin can prevent an early death in patients with diabetes, extending life expectancy by as much as 4.5 years."

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.⁴ Modelling based on the EMPA-REG OUTCOME^® trial data was used to quantify the potential benefit of empagliflozin on residual life span.

"For people with type 2 diabetes and a history of heart disease, this analysis illustrates the benefit of treating with medication that not only lowers glucose but reduces cardiovascular risk," says Dr. Jan Hux, President and CEO of Diabetes Canada. "Diabetes contributes to 30 per cent of strokes and 40 per cent of heart attacks in this country, which is why Diabetes Canada has updated its guidelines in recent years to reflect the importance of identifying and managing cardiovascular risk."

*Actuarial methods refer to the statistical techniques and analysis used to prepare mortality and other analytical tables

About Diabetes and Cardiovascular Disease
Canada has the second highest rate of type 2 diabetes in the developed world,⁵ with over 3.5 million Canadians currently living with the disease, and another seven million at risk of diagnosis.⁶ Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes.⁷

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.^{8, 9, 10} Research from the recent My Heart Matters survey reveals that, although most Canadians with type 2 diabetes (93 per cent) feel they are knowledgeable about their disease management, one in two are unaware their diabetes alone significantly increases the risk of heart attack, heart failure and stroke.^{11, 12}

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.¹³

Diabetes Canada recommends 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).¹⁴

About the EMPA-REG OUTCOME^® trial ¹⁵
The EMPA-REG OUTCOME^® trial was a long-term, multicentre, randomized, 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.

About Empagliflozin
Empagliflozin 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.^{16, 17, 18}

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. For more information about the Alliance visit www.boehringer-ingelheim.ca or www.lilly.ca.

About Boehringer Ingelheim (Canada) Ltd.
Improving the health and quality of life of patients is the goal of Boehringer Ingelheim, a research-driven pharmaceutical company. In doing so, the focus 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 top 20 companies in the pharmaceutical industry. 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. Research and development 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, rather than short-term profit. 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.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.ca or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Eli Lilly Canada
Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

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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 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

³ 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

⁴ Zinman B. et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-2128.

⁵ Canadian Institute for Health Information. International Comparisons: A Focus on Diabetes. November 4, 2015.

⁶ Diabetes Canada. "Diabetes in Canada".  Backgrounder, March 2018. Available at: https://www.diabetes.ca/getmedia/6960f8d5-0869-4233-8ac2-6c669dae7c59/2018-Backgrounder-Canada_KH_AB_KB-edited-13-March-2018_2.pdf.aspx

⁷ Diabetes Canada. "Types of Diabetes".  Diabetes, 2018. Available at: https://www.diabetes.ca/about-diabetes/types-of-diabetes

⁸ Diabetes Canada. "Complications". Diabetes and You, 2018. Available at: https://www.diabetes.ca/diabetes-and-you/complications/heart-disease-stroke

⁹ Nwaneri C, Cooper H, Bowen-Jones D. Mortality in type 2 diabetes mellitus: magnitude of the evidence from a systematic review and meta-analysis. The British Journal of Diabetes & Vascular Disease. 2013;13(4):192–207.

¹⁰ Morrish NJ, et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44 Suppl 2:S14–21.

¹¹ Environics Research Group. "My Heart Matters Survey": Online survey conducted among 1,500 Canadians over 18 years of age was completed online between April 13 and May 4, 2018. Slide 5. Table S9 (row 293) in 2018.

¹² Environics Research Group. "My Heart Matters Survey": Online survey conducted among 1,500 Canadians over 18 years of age was completed online between April 13 and May 4, 2018. Slide 11.

¹³ The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.

¹⁴ 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.

¹⁵ Zinman B. et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-2128.

¹⁶ Jardiance Product Monograph. Boehringer Ingelheim (Canada) Ltd. April 16, 2018. Last accessed August 2018.

¹⁷  European Summary of Product Characteristics Jardiance^®, approved May 2018. Data on file. 

¹⁸ Jardiance^® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf

SOURCE Boehringer Ingelheim (Canada) Ltd.

Jennifer Mota, Brand Communications Specialist, Boehringer Ingelheim (Canada) Ltd., Email: [email protected], Phone: [phone]; Helen Stone, Communications Manager, Eli Lilly Canada, Email: [email protected], Phone: [phone]