Jardiance® reduced risk of cardiovascular death in adults with type 2 diabetes and peripheral artery disease

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2017 — New data presented today showed that Jardiance^® 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.

"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 has 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. 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. If peripheral artery disease is not managed properly, it can also lead to amputation, which may result in hospitalization, disability and death.

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:

• Jardiance reduced the risk of cardiovascular death by 43 percent
• Death from any cause was reduced by 38 percent and hospitalization 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 Jardiance 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 Jardiance 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 Jardiance 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 Jardiance may help a wide range of people living with type 2 diabetes and its complications," said Rogelio Braceras, M.D., therapeutic area head, Clinical Development & Medical Affairs, Metabolism, Boehringer Ingelheim Pharmaceuticals, Inc. "The data presented and published at the AHA Scientific Sessions showed that Jardiance reduced the risk for cardiovascular death and kidney disease in this highly vulnerable population of people with type 2 diabetes and peripheral artery disease."

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.

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.