RIDGEFIELD, Conn and
INDIANAPOLIS, Aug. 20, 2015 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced
positive top-line results from EMPA-REG OUTCOME®. This
is a long-term clinical trial investigating cardiovascular (CV)
outcomes for Jardiance® (empagliflozin) in more than
7,000 adults with type 2 diabetes (T2D) at high risk for CV events.
EMPA-REG OUTCOME met its primary endpoint and demonstrated
superiority of JARDIANCE, when added to standard of care, in CV
risk reduction. The primary endpoint was defined as time to first
occurrence of either CV death, or non-fatal myocardial infarction
or non-fatal stroke.
JARDIANCE is the only glucose-lowering agent to have
demonstrated CV risk reduction in a dedicated cardiovascular
outcomes trial.
"The cardiovascular risk reduction JARDIANCE demonstrated in the
EMPA-REG OUTCOME trial is exciting and we look forward to sharing
the full results," said Prof. Hans-Juergen
Woerle, global vice president medicine, Boehringer
Ingelheim. "Approximately 50 percent of deaths in people with type
2 diabetes worldwide are caused by cardiovascular disease. Reducing
cardiovascular risk is an essential component of diabetes
management."
The safety profile of JARDIANCE was consistent with previous
studies. Detailed study results will be presented on September
17 at the 51st European Association for the Study
of Diabetes Annual Meeting in Stockholm,
Sweden.
About the Study
EMPA-REG OUTCOME was a
multicenter, randomized, double-blind, placebo-controlled trial
that involved more than 7,000 individuals from 42 countries
observed for a median duration of 3.1 years. The study was designed
to assess the effect of JARDIANCE (10mg or 25mg once daily) added
to standard of care compared with placebo added to standard of care
on CV events in adults with T2D at high risk of CV events and with
less than optimized blood glucose control. The study was designed
to first test for non-inferiority and then for superiority.
Standard of care was comprised of glucose lowering agents and
cardiovascular drugs (including antihypertensive and lipid lowering
agents).
What is JARDIANCE
JARDIANCE is a once-daily pill taken in the morning, used along
with diet and exercise, to lower blood sugar (A1C) in adults with
type 2 diabetes.
JARDIANCE is not for people with type 1 diabetes or for people
with diabetic ketoacidosis (increased ketones in the blood or
urine).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
JARDIANCE?
JARDIANCE can cause serious side effects,
including:
Dehydration. JARDIANCE can
cause some people to have dehydration (the loss of body water and
salt).
Dehydration may cause you to feel dizzy, faint, light-headed, or
weak, especially when you stand up.
You may be at a higher risk of dehydration if you:
-
- have low blood pressure
- take medicines to lower your blood pressure, including water
pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older.
- Vaginal yeast infection. Women who take JARDIANCE may get
vaginal yeast infections. Talk to your doctor if you experience
vaginal odor, white or yellowish vaginal discharge (discharge may
be lumpy or look like cottage cheese), and/or vaginal itching.
- Yeast infection of the penis. Men who take JARDIANCE may
get a yeast infection of the skin around the penis, especially
uncircumcised males and those with chronic infections. Talk to your
doctor if you experience redness, itching or swelling of the penis,
rash of the penis, foul smelling discharge from the penis, and/or
pain in the skin around the penis.
Who should not take JARDIANCE?
- Do not take JARDIANCE if you are allergic to
empagliflozin or any of the ingredients in JARDIANCE.
- Symptoms of serious allergic reactions to JARDIANCE may
include:
- skin rash
- raised red patches on your skin (hives)
- swelling of the face, lips, tongue, and throat that may cause
difficulty breathing or swallowing.
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
- Do not take JARDIANCE if you have severe kidney
problems or are on dialysis.
What should I tell my doctor before using JARDIANCE?
Tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check
your kidneys before and during your treatment with JARDIANCE.
- have liver problems
- have a history of urinary tract infections or problems with
urination
- have any other medical conditions
- are pregnant or planning to become pregnant. It is unknown if
JARDIANCE will harm your unborn baby.
- are breastfeeding, or plan to breastfeed. It is unknown if
JARDIANCE passes into your breast milk.
Tell your doctor about all the medicines you
take including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Especially tell your
doctor if you take water pills (diuretics) or medicines that can
lower your blood sugar such as insulin.
What are other possible side effects of JARDIANCE?
- Low blood sugar (hypoglycemia): if you take
JARDIANCE with another medicine that can cause low blood sugar,
such as sulfonylurea or insulin, your risk of low blood sugar is
higher. The dose of your sulfonylurea or insulin may need to be
lowered. Symptoms of low blood sugar may include:
- Headache
- Confusion
- Sweating
- Drowsiness
- Irritability
- Shaking or feeling jittery
- Weakness
- Hunger
- Dizziness
- Fast heart beat
- Kidney Problems, especially in people 75 years of
age or older and people who already have kidney problems.
- Urinary Tract Infection: symptoms may include
burning feeling when passing urine, pain in the pelvis or back, or
urine that looks cloudy.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE include
urinary tract infections and yeast infections in females.
You are encouraged to report negative side effects of
prescription drugs to the
FDA.
Visit www.fda.gov/medwatch or call
1‑800‑FDA‑1088.
For more information, please see Full Prescribing
Information, including Patient Information.
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance in diabetes that
centers on compounds representing several of the largest diabetes
treatment classes. This alliance leverages the strengths of two of
the world's leading pharmaceutical companies. By joining forces,
the companies demonstrate commitment in the care of patients with
diabetes and stand together to focus on patient needs. Find out
more about the alliance at http://www.boehringer-ingelheim.com or
www.lilly.com.
About Boehringer Ingelheim Pharmaceuticals,
Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.,
based in Ridgefield, CT, is the
largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with
146 affiliates and more than 47,000 employees. Since its founding
in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel
treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and
providing valuable services and support to patients and
families. Our employees create and engage in programs that
strengthen our communities.
To learn more about how we make more health for more people,
visit our Corporate Social Responsibility Report.
In 2014, Boehringer Ingelheim achieved net sales of about
$16.96 billion dollars (13.3 billion euros). R&D expenditure
corresponds to 19.9 percent of its net sales.
For more information please
visit www.us.boehringer-ingelheim.com, or follow us on Twitter
@BoehringerUS.
About Lilly Diabetes
Lilly has been a global
leader in diabetes care since 1923, when we introduced the world's
first commercial insulin. Today we are building upon this heritage
by working to meet the diverse needs of people with diabetes and
those who care for them. Through research and collaboration, a
broad and growing product portfolio and a continued determination
to provide real solutions—from medicines to support programs and
more—we strive to make life better for all those affected by
diabetes around the world. For more information, visit
www.lillydiabetes.com or follow @LillyDiabetes.
About Eli Lilly and Company
Lilly is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about empagliflozin as a treatment for patients with
type 2 diabetes along with diet and exercise 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 empagliflozin 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.
CONTACTS:
|
|
Emily Baier
Geary
|
Molly
McCully
|
Director, Public
Relations
|
Communications
Manager
|
Boehringer Ingelheim
Pharmaceuticals Inc.
|
Lilly
Diabetes
|
Email:
emily.geary@boehringer-ingelheim.com
|
Email:
mccully_molly@lilly.com
|
Phone: +1 (203) 791
5997
|
Phone: +1 (317) 478
5423
|
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
Pharmaceuticals, Inc.