BOEHRINGER-INGELHEIM

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

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“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.

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/AHA-2017-Empagliflozin .

View source version on businesswire.com: http://www.businesswire.com/news/home/20171114005733/en/

Contact:

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Lilly Diabetes
Molly McCully
Communications
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423