Results from an analysis of the EMPA-REG OUTCOME® trial were

presented in a late-breaking session at the 2015 Scientific Sessions of the

American Heart Association

INGELHEIM, Germany & INDIANAPOLIS, US - Monday,

November 9th 2015 [ME NewsWire]

(BUSINESS WIRE)-- New sub-analysis data presented today show the

reduction in risk for hospitalisation for heart failure or cardiovascular

(CV) death with Jardiance®, compared with placebo when added to

standard of care in patients with type 2 diabetes (T2D) at high risk of

CV events, was consistent across all sub-groups analysed, including

those who had heart failure at baseline and those who did not. These

results were presented on behalf of Boehringer Ingelheim and Eli Lilly

and Company (NYSE: LLY) at the 2015 Scientific Sessions of the

American Heart Association (AHA) in Orlando, U.S. The data were

part of a pre-specified analysis of secondary endpoints of the landmark

EMPA-REG OUTCOME® trial.

“Cardiovascular disease, including heart failure, is the leading cause of

death associated with diabetes,” said Prof. Silvio Inzucchi, Professor of

Medicine, Yale School of Medicine. “People with diabetes are two- to

three-times more likely to develop heart failure than those individuals

without diabetes. We need treatments that can help reduce the high

rates of heart failure—and the resulting hospitalisations and deaths—in

this population.”

New data, also presented today, demonstrate Jardiance® (empagliflozin)

reduced the risk of the composite endpoint of rates of hospitalisation

for heart failure or death from heart failure by 39 percent compared

with placebo when added to standard of care in patients with T2D at

high risk of CV events.

“To date, no glucose-lowering medication has been shown to reduce the

risk of hospitalisation for heart failure or death from heart failure in a

cardiovascular outcomes study,” said Prof. Hans-Juergen Woerle,

Global Vice President Medicine, Boehringer Ingelheim. “These results

with Jardiance® show the importance of continuing to advance research

that will help our understanding of how to manage and mitigate the risk

of cardiovascular disease in people with type 2 diabetes.”

About EMPA-REG OUTCOME®

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

double-blind, placebo-controlled trial of more than 7,000 patients from

42 countries with T2D at high risk for CV events.

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

CV drugs (including for blood pressure and cholesterol). The primary

endpoint was defined as time to first occurrence of CV death, non-fatal

heart attack or non-fatal stroke.

Over a median of 3.1 years, Jardiance® significantly reduced the risk of

CV death, non-fatal heart attack or non-fatal stroke by 14 percent

versus placebo. 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. Treatment with Jardiance® also resulted in a 32 percent reduced

risk of all-cause mortality and a 35 percent reduced risk of

hospitalisation for heart failure.

The overall safety profile of Jardiance® was consistent with that of

previous trials. The incidence of diabetic ketoacidosis was at or below

0.1 percent and similar across all treatment groups.

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.

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

https://www.boehringer-

ingelheim.com/news/news_releases/press_releases/2015/09_november_2

015diabetes.html

Contacts

Boehringer Ingelheim GmbH

Marco Winkler

Product Communication Manager

Email: press@boehringer-ingelheim.com

Phone: +49 (151) 689 46812

Lilly Diabetes

Molly McCully

Communications Manager

Email: mccully_molly@lilly.com

Phone: +1 (317) 478 5423

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