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Boehringer Ingelheim. (11/14/17). "Press Release: Jardiance Reduced Risk of Cardiovascular Death in Adults with Type 2 Diabetes and Peripheral Artery Disease". Ingelheim & Indianapolis, IN.

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 American Heart Association (AHA)
Products Product Jardiance®
  Product 2 clinical research
     


> Empagliflozin (marketed as Jardiance®) reduced the risk of cardiovascular death by 43 percent versus placebo in patients with type 2 diabetes and peripheral artery disease1

> In a population at high risk for amputations, no increased risk in lower-limb amputation was observed with empagliflozin treatment1


New data showed that empagliflozin reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. These results, from a post-hoc analysis of the landmark EMPA-REG OUTCOME® trial, were shared as an oral presentation on behalf of Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, Calif. and simultaneously published online in the AHA’s journal Circulation.1

“Peripheral artery disease, one of the most common cardiovascular complications associated with type 2 diabetes, increases the risk of death from cardiovascular causes,” said Subodh Verma, M.D., cardiac surgeon-scientist at St. Michael’s Hospital and professor at the University of Toronto. “There is an urgent need for treatment options that can improve cardiovascular-related outcomes in people with type 2 diabetes and peripheral artery disease.”

Approximately one in three people with diabetes over the age of 50 have peripheral artery disease, a narrowing of the arteries outside the heart, usually those leading to the arms, legs and feet, due to a buildup of fatty deposits.2 Peripheral artery disease can be life-threatening when blockages restrict circulation causing damage to limbs and can also be associated with damage to vital organs such as the heart, kidneys and brain.3 If peripheral artery disease is not managed properly, it can also lead to amputation, which may result in hospitalization, disability and death.4

At study start, 21 percent of the more than 7,000 EMPA-REG OUTCOME® trial participants had existing peripheral artery disease. The analysis in this patient population showed that compared with placebo, on top of standard of care:

> Empagliflozin reduced the risk of cardiovascular death by 43 percent

> Death from any cause was reduced by 38 percent and hospitalisation for heart failure by 44 percent

> Risk for the composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke was reduced by 16 percent

> New or worsening kidney disease, known as nephropathy, was reduced by 46 percent

> Overall, the cardiovascular and renal effects observed in patients with peripheral artery disease were consistent with previously reported results of the overall trial population in EMPA-REG OUTCOME®

Overall side effects and serious side effects were balanced between the empagliflozin and placebo groups in adults with and without peripheral artery disease. In the group with peripheral artery disease, lower-limb amputations occurred in 5.5 percent of those treated with empagliflozin and 6.3 percent of those treated with placebo. In the group without peripheral artery disease, lower-limb amputations occurred in 0.9 percent of those treated with empagliflozin and 0.7 percent of those treated with placebo.

“Through ongoing sub-analyses of the EMPA-REG OUTCOME® data, we are gaining a better understanding of how empagliflozin may help a wide range of people living with type 2 diabetes and its complications,” said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “The data presented and published at the AHA Scientific Sessions showed that empagliflozin reduced the risk for cardiovascular death and kidney disease in this highly vulnerable population of people with type 2 diabetes and peripheral artery disease.”


About Diabetes and Cardiovascular Disease

More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed.5 By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide.5 T2D is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries.5 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.5

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, CV disease is a major complication and the leading cause of death associated with diabetes.6,7 People with diabetes are two to four times more likely to develop CV disease than people without diabetes.7 In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause.5,7 Approximately 50 percent of deaths in people with T2D worldwide are caused by CV disease.8,9

Having a history of diabetes at age 60 can shorten a person’s lifespan 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 lifespan by as much as 12 years compared with someone without these conditions.10


About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.

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 (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.11
Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).


About EMPA-REG OUTCOME®12

EMPA-REG OUTCOME® 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 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.

Over a median of 3.1 years, empagliflozin significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. The risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of empagliflozin was consistent with that of previous trials.


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

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

More information about Boehringer Ingelheim can be found on http://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 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 (link is external).


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 (link is external) and newsroom.lilly.com/social-channels (link is external).


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 Jardiance 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.


CONTACT:

Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877

Molly McCully
Communications
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423


References

1. Verma Subodh, et al. Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients with Type 2 Diabetes and Peripheral Artery Disease: A Sub-Analysis of the EMPA-REG OUTCOME Trial. Oral Presentation at the American Heart Association Scientific Sessions 2017. Nov. 11 – 15, Anaheim, California.
2. American Diabetes Association. Peripheral Arterial Disease (PAD). Available at: http://www.diabetes.org/living-with-diabetes/complications/heart-disease/peripheral-arterial-disease.html. Last Accessed November 2017.
3. American Heart Association. Why PAD Matters. Available at: http://www.heart.org/HEARTORG/Conditions/VascularHealth/PeripheralArteryDisease/Why-PAD-Matters_UCM_301303_Article.jsp#.Wfxnr7acZGO . Last accessed November 2017.
4. University of Maryland Medical Center. Peripheral artery disease and intermittent claudication. Available at: http://www.umm.edu/health/medical/reports/articles/peripheral-artery-disease-and-intermittent-claudication
Last accessed November 2017.
5. International Diabetes Federation. IDF Diabetes Atlas, 7th edition. Brussels, Belgium 2015. Available at: www.diabetesatlas.org. Last accessed November 2017.
6. World Health Organisation. Diabetes: fact sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/# . Last accessed November 2017.
7. 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 November 2017.
8. Nwaneri C, et al. 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;13:192–207.
9. 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.
10. The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.
11. European Summary of Product Characteristics Jardiance®, approved January 19, 2017. Data on file. Available at: https://ec.europa.eu/health/documents/community-register/html/h930.htm. Last accessed November 2017.
12. Zinman B., et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med; 2015;10.1056.

   
Record changed: 2017-11-26

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