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EMPA-REG OUTCOME®: Top-line renal data to be presented during American Society of Nephrology (ASN) Kidney Week 2015

Boehringer Ingelheim and Eli Lilly and Company today announced that top-line renal results from the EMPA-REG OUTCOME® study (compound empagliflozin, marketed under the name Jardiance® ) will be presented during American Society of Nephrology (ASN) Kidney Week 2015 in San Diego.

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The data will be presented during the oral abstract session:

High Impact Clinical Trials

Saturday 7 November, 10:30–10:45 a.m. PT, Oral Presentation: Empagliflozin and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Chronic Kidney Disease (Christoph Wanner)

Kidney disease (nephropathy) is far more common in people with diabetes than in people without diabetes; and diabetes is one of the leading causes of chronic kidney disease.

The full renal data set is currently being analysed and comprehensive study results on renal outcomes of patients in EMPA-REG OUTCOME® are expected to be published in a peer-reviewed journal in due course.

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 type 2 diabetes at high risk for cardiovascular (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.

About Jardiance ®

Jardiance® (empagliflozin) is an oral, once daily, highly selective 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.

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

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/06_november_2015diabetes.html

Contact:

Boehringer Ingelheim GmbH
Marco Winkler
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (151) 689 46812
or
Lilly Diabetes
Molly McCully
Communications Manager
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423

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