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INGELHEIM, GERMANY & INDIANAPOLIS, US--( / ) November 15, 2016 -- New data presented at the American Heart Association Scientific Sessions 2016 showed that Jardiance® (empagliflozin) consistently reduced the risk for cardiovascular death, regardless of the type of cardiovascular disease at baseline, compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. The findings are part of the landmark EMPA-REG OUTCOME® trial, which is the first trial of a diabetes medication to show a reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This study is supported by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).

“Cardiovascular disease is two to four times more common in people with type 2 diabetes and is an umbrella term consisting of several different vascular outcomes, including heart attack, heart failure, peripheral vascular disease and stroke,” said lead investigator of the trial Dr Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital, Toronto; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. “Since approximately 50 percent of deaths in people with type 2 diabetes worldwide are attributed to cardiovascular causes, we need diabetes therapies that help reduce this complication in individuals who have an underlying cardiovascular issue.”

For this post hoc analysis, trial participants were grouped based on type of cardiovascular disease at baseline, which included history of heart attack, stroke, heart failure, atrial fibrillation and existing peripheral artery disease. Lower rates of cardiovascular death were seen in the Jardiance® group independent of cardiovascular disease type. Observed adverse events were consistent with the known safety profile of Jardiance®.

“Jardiance is the only oral type 2 diabetes medicine shown in a clinical trial to reduce the risk of cardiovascular death,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Metabolism, Boehringer Ingelheim. “These results provide further evidence and reinforce the strength of the EMPA-REG OUTCOME data demonstrating a reduction in risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.”

About the EMPA-REG OUTCOME® Trial

EMPA-REG OUTCOME® was a long-term, multicentre, randomised, 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.

Over a median of 3.1 years, Jardiance® significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of cardiovascular death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

The safety profile of Jardiance® in the EMPA-REG OUTCOME® trial was consistent with that of previous trials. The overall incidence of adverse events was similar to placebo.

About Diabetes and Cardiovascular Disease

More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. Type 2 diabetes is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either 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. In 2015, diabetes caused 5 million deaths worldwide, with cardiovascular disease as the leading cause. Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.

About Jardiance®

Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 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.

Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.

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

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 as a treatment of adults with type 2 diabetes and established cardiovascular disease, 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.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

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