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
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.
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).
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’:
Boehringer Ingelheim GmbH
Product Communication Manager
Phone: +49 (151) 689 46812
Phone: +1 (317) 478 5423