Boehringer Ingelheim Release: New Jardiance (Empagliflozin) Data Show Improved CV Outcomes Regardless Of Heart Failure Status At Baseline

• 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--(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.

“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.”

“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 ß-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_2015diabetes.html

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