Jardiance® (empagliflozin) tablets reduced risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease independent of background blood sugar control

- Three sub-analyses of the EMPA-REG OUTCOME® trial in adults with type 2 diabetes and established cardiovascular disease presented at the 53rd European Association for the Study of Diabetes Annual Meeting 2017
- Irrespective of their blood sugar control at study start, participants taking Jardiance had a lower risk of cardiovascular death compared to placebo
- Jardiance also reduced the risk of cardiovascular death compared to placebo regardless of background metformin or sulfonylurea use

RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I September 12, 2017 I New analyses of the landmark EMPA-REG OUTCOME® trial showed that Jardiance® (empagliflozin) tablets reduced the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study. A reduction in cardiovascular death was also seen when Jardiance was added to common first and second-line diabetes medications, such as metformin or sulfonylurea. These results from post-hoc analyses were presented by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.

"Now that we have a new option for reducing the risk of cardiovascular death among adults with type 2 diabetes, we are striving to better understand if there are differences in how adults with type 2 diabetes can benefit," said Silvio Inzucchi, M.D., professor of medicine, Yale School of Medicine, who presented the data today. "These new analyses of the EMPA-REG OUTCOME trial showed empagliflozin was effective in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments."

In all four blood sugar level groups at study start (A1C levels of < 7.0 percent, 7.0 percent to < 8.0 percent, 8.0 percent to < 9.0 percent and ≥9.0 percent), patients receiving Jardiance demonstrated a reduction in the risk of cardiovascular death compared with placebo. This was consistent with the risk reduction seen in the overall trial population and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decrease in A1C level of ≥ 0.5 percent at week 12).

Additional post-hoc analyses showed that when Jardiance was added to metformin or sulfonylurea, the reduction of cardiovascular death compared with placebo was consistent with the overall trial population. These analyses also showed the proportion of patients with hypoglycemic side effects were similar between the placebo and Jardiance groups in the EMPA-REG OUTCOME trial.

Jardiance is the first and only oral type 2 diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance in EMPA-REG OUTCOME was consistent with that of previous studies of Jardiance and current label information.

"Cardiovascular disease remains the leading cause of death in people with type 2 diabetes and contributes significantly to the burden of diabetes care," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "The results presented at EASD add further evidence of the benefit Jardiance can provide to adults with type 2 diabetes with different background blood sugar control."

"Boehringer Ingelheim and Lilly are committed to advancing the understanding of the EMPA-REG OUTCOME data to help physicians better tailor their treatment approach, since proper type 2 diabetes management requires a personalized plan," said Rogelio Braceras, M.D., therapeutic area head, Clinical Development & Medical Affairs, Metabolism, Boehringer Ingelheim Pharmaceuticals, Inc. "We're pleased that Jardiance's life-saving cardiovascular benefit to reduce the risk of cardiovascular death was consistent in the trial regardless of the baseline variables we tested, including blood sugar levels."

About Diabetes and Cardiovascular Disease
Approximately 30 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 24 percent of Americans with diabetes—or more than 7 million people—are undiagnosed. In the U.S., approximately nine percent of those aged 18 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

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. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and approximately two-thirds of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., healthcare costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.

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.

About the EMPA-REG OUTCOME Trial (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, 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 Jardiance (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 Jardiance was consistent with that of previous trials.

About Educational Initiatives
Given the critical connection between diabetes and cardiovascular disease, Boehringer Ingelheim and Eli Lilly and Company are committed to providing a wide range of diabetes therapies along with programs and support to raise awareness, understanding and action toward reducing the impact of cardiovascular disease in people with type 2 diabetes.

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

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. This alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

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.   

SOURCE: Eli Lilly

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