RIDGEFIELD, Conn., and
INDIANAPOLIS, Sept. 17, 2015 /PRNewswire/ -- Boehringer
Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company's
(NYSE: LLY) Jardiance® (empagliflozin) significantly
reduced the risk of the combined endpoint of cardiovascular (CV)
death, non-fatal heart attack or non-fatal stroke by 14 percent
when added to standard of care in patients with type 2 diabetes
(T2D) at high risk of CV events. There was a 38 percent reduction
in CV death, with no significant difference in the risk of
non-fatal heart attack or non-fatal stroke.
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7617351-bi-lilly-empa-reg-cv-results
In addition, treatment with JARDIANCE resulted in a lower risk
of all-cause mortality (32 percent reduction) and hospitalization
for heart failure (35 percent reduction).
"These results are both novel and exciting for the millions of
people living with type 2 diabetes at risk for cardiovascular
disease. Addressing the burden of cardiovascular events, including
death, is at the core of diabetes care, and until now no single
diabetes medication has been associated with a reduction in
mortality," said lead investigator of the trial Bernard Zinman, M.D., Director, Diabetes Centre,
Mount Sinai Hospital; Senior Scientist, Lunenfeld Tanenbaum
Research Institute, and Professor of Medicine, University of Toronto, Canada. "In this study,
empagliflozin was shown to prevent one out of three cardiovascular
deaths."
Life expectancy of people with T2D at high CV risk is, on
average, decreased by up to 12 years with approximately 50 percent
of deaths in people with T2D caused by CV disease. The effect of
JARDIANCE in this trial was observed on top of standard of care.
This means the benefit was seen over and above other treatments
patients were already receiving for diabetes and/or cardiovascular
disease (such as blood pressure and cholesterol
lowering-medications).
"The EMPA-REG OUTCOME trial results are encouraging for
healthcare professionals and their patients," said Christopher P. Cannon, M.D., Cardiovascular
Division, Brigham and Women's
Hospital and Professor of Medicine, Harvard Medical School, who was not involved in the
study. "Patients in the study were already being treated with
medications that have been proven to reduce cardiovascular events.
The observation that empagliflozin provided additional
cardiovascular death reduction on top of these other medications is
a very important finding."
The overall safety profile of JARDIANCE was consistent with
previous trials. The incidence of diabetic ketoacidosis was at or
below 0.1 percent and similar across all treatment groups.
These data were presented today at the 51st European
Association for the Study of Diabetes Annual Meeting in
Stockholm, Sweden, and
simultaneously published in the New England Journal of
Medicine.
"The Boehringer Ingelheim and Lilly Diabetes Alliance is very
pleased to share the results of the EMPA-REG OUTCOME trial with the
healthcare community," said Prof. Hans-Juergen Woerle, Global Vice President
Medicine, Boehringer Ingelheim. "Cardiovascular disease is the
number one cause of death in people with type 2 diabetes worldwide
and reducing cardiovascular risk, including death, is an essential
component of diabetes management."
About EMPA-REG OUTCOME
EMPA-REG OUTCOME was a
long-term, multicenter, randomized, double-blind,
placebo-controlled trial that involved more than 7,000 patients
from 42 countries with type 2 diabetes at high risk for
cardiovascular events. There were 772 primary outcome events in the
EMPA-REG OUTCOME trial over a median observation period 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. The primary endpoint was defined as time
to first occurrence of either CV death, or non-fatal heart attack
or non-fatal stroke. 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 blood pressure and
cholesterol-lowering medications).
Of the 7,020 treated patients, more than 97 percent completed
the trial and vital status was available for more than 99 percent
of these patients at study end. Analyses and results were
independently validated and confirmed by the University of Freiburg, Germany, an internationally
renowned academic center specializing in statistical analyses.
About Diabetes
Approximately 29 million Americans and
an estimated 387 million people worldwide have type 1 or type 2
diabetes, and nearly 28 percent of Americans with diabetes—totaling
8 million people—are undiagnosed. In the U.S., approximately 12
percent of those aged 20 and older have diabetes. T2D is the most
common type, accounting for an estimated 90 to 95 percent of all
diagnosed adult diabetes cases in the U.S. Diabetes is a chronic
condition that occurs when the body either does not properly
produce, or use, the hormone insulin.
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.
JAR CONS ISI 8.1.2014
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 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.
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.
Jardiance® is a registered trademark of Boehringer Ingelheim
P-LLY
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and
Company