RIDGEFIELD, Conn. and
INDIANAPOLIS, Nov. 9, 2015 /PRNewswire/ -- New
sub-analysis data presented today showed the reduction in risk for
hospitalization for heart failure or cardiovascular death with
Jardiance® (empagliflozin) compared with placebo when added to
standard of care in patients with type 2 diabetes (T2D) at high
risk of cardiovascular (CV) events was consistent across all
sub-groups analyzed, including those who had heart failure at
baseline and those who did not. These results were presented
on behalf of Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and
Eli Lilly and Company (NYSE: LLY) at the 2015 Scientific Sessions
of the American Heart Association in Orlando, Fla. 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 Silvio Inzucchi, M.D., 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 hospitalizations and deaths—in this population."
New data also presented today demonstrate JARDIANCE reduced the
risk of the composite endpoint of rates of hospitalization 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 hospitalization 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, multicenter, randomized,
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 hospitalization 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 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
PR-JAR-0008
CONTACT:
Emily Baier
Geary
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: emily.geary@boehringer-ingelheim.com
Phone: (203) 297 1464
Molly
McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478 5423
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
Pharmaceuticals, Inc.