RIDGEFIELD, Conn. and
INDIANAPOLIS, Nov. 13, 2017 /PRNewswire/ -- New
data presented today showed that Jardiance® reduced the
risk of cardiovascular death compared with placebo when added to
standard of care in adults with type 2 diabetes and peripheral
artery disease. These results, from a post-hoc analysis of the
landmark EMPA-REG OUTCOME® trial, were shared as an oral
presentation on behalf of Boehringer Ingelheim and Eli Lilly and
Company (NYSE: LLY) at the American Heart Association® (AHA)
Scientific Sessions 2017 in Anaheim,
Calif. and simultaneously published online in the AHA's
journal, Circulation.
"Peripheral artery disease, one of the most common
cardiovascular complications associated with type 2 diabetes,
increases the risk of death from cardiovascular causes," said
Subodh Verma, M.D., cardiac
surgeon-scientist at St. Michael's
Hospital and professor at the University of
Toronto. "There is an urgent need for treatment options that
can improve cardiovascular-related outcomes in people with type 2
diabetes and peripheral artery disease."
Approximately one in three people with diabetes over the age of
50 has peripheral artery disease, a narrowing of the arteries
outside the heart, usually those leading to the arms, legs and
feet, due to a buildup of fatty deposits. Peripheral artery disease
can be life-threatening when blockages restrict circulation,
causing damage to limbs, and can also be associated with damage to
vital organs such as the heart, kidneys and brain. If peripheral
artery disease is not managed properly, it can also lead to
amputation, which may result in hospitalization, disability and
death.
At study start, 21 percent of the more than 7,000 EMPA-REG
OUTCOME trial participants had existing peripheral artery disease.
The analysis in this patient population showed that compared with
placebo, on top of standard of care:
- Jardiance reduced the risk of cardiovascular death by 43
percent
- Death from any cause was reduced by 38 percent and
hospitalization for heart failure by 44 percent
- Risk for the composite endpoint of cardiovascular death,
non-fatal heart attack or non-fatal stroke was reduced by 16
percent
- New or worsening kidney disease, known as nephropathy, was
reduced by 46 percent
- Overall, the cardiovascular and renal effects observed in
patients with peripheral artery disease were consistent with
previously reported results of the overall trial population in
EMPA-REG OUTCOME
Overall side effects and serious side effects were balanced
between the Jardiance and placebo groups in adults with and without
peripheral artery disease. In the group with peripheral artery
disease, lower-limb amputations occurred in 5.5 percent of those
treated with Jardiance and 6.3 percent of those treated with
placebo. In the group without peripheral artery disease, lower-limb
amputations occurred in 0.9 percent of those treated with Jardiance
and 0.7 percent of those treated with placebo.
"Through ongoing sub-analyses of the EMPA-REG OUTCOME data, we
are gaining a better understanding of how Jardiance may help a wide
range of people living with type 2 diabetes and its complications,"
said Rogelio Braceras, M.D.,
therapeutic area head, Clinical Development & Medical Affairs,
Metabolism, Boehringer Ingelheim Pharmaceuticals, Inc. "The data
presented and published at the AHA Scientific Sessions showed that
Jardiance reduced the risk for cardiovascular death and kidney
disease in this highly vulnerable population of people with type 2
diabetes and peripheral artery disease."
Jardiance is the first and only oral type 2 diabetes medicine
approved to reduce the risk of cardiovascular death in adults with
type 2 diabetes and established cardiovascular disease.
About Diabetes and Cardiovascular Disease
Approximately 30 million Americans and an estimated 415 million
people worldwide have diabetes, and nearly 24 percent of Americans
with diabetes—or more than 7 million people—are undiagnosed. In the
U.S., approximately nine percent of those aged 18 and older have
diabetes. Type 2 diabetes 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 does not properly produce or use the hormone insulin.
Due to the complications associated with diabetes, such as high
blood sugar, high blood pressure and obesity, cardiovascular
disease is a major complication and the leading cause of death
associated with diabetes. People with diabetes are two to four
times more likely to develop cardiovascular disease than people
without diabetes. Approximately 50 percent of deaths in people
with type 2 diabetes worldwide and approximately two-thirds of
deaths in people with type 2 diabetes in the U.S. are caused by
cardiovascular disease. In the U.S., healthcare costs for managing
cardiovascular conditions in patients with diabetes totaled more
than $23 billion in 2012.
Having a history of diabetes at age 60 can shorten a person's
lifespan by as much as six years compared with someone without
diabetes. And having both diabetes and a history of heart attack or
stroke at age 60 can shorten a person's lifespan by as much as 12
years compared with someone without these conditions.
About the EMPA-REG OUTCOME Trial
(NCT01131676)
EMPA-REG OUTCOME was a
long-term, multicenter, randomized, double-blind,
placebo-controlled trial of more than 7,000 patients from 42
countries with type 2 diabetes and established cardiovascular
disease.
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 cardiovascular drugs (including for
blood pressure and cholesterol). The primary endpoint was defined
as time to first occurrence of cardiovascular death, non-fatal
heart attack or non-fatal stroke.
The overall safety profile of Jardiance was consistent with that
of previous trials.
About Educational Initiatives
Given the critical
connection between diabetes and cardiovascular disease, Boehringer
Ingelheim and Eli Lilly and Company are committed to providing a
wide range of diabetes therapies along with programs and support to
raise awareness, understanding and action toward reducing the
impact of cardiovascular disease in people with type 2
diabetes.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and
exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular
death in adults with type 2 diabetes who have known cardiovascular
disease.
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.
- Ketoacidosis (increased ketones in your blood or urine).
Ketoacidosis is a serious condition and may need to be treated in
the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs
in people with type 1 diabetes and can also occur in people with
type 2 diabetes taking JARDIANCE, even if blood sugar is less than
250 mg/dL. Stop taking JARDIANCE and call your doctor right away
if you get any of the following symptoms, and if possible,
check for ketones in your urine:
-
- nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- Serious urinary tract infections. Serious urinary tract
infections can occur in people taking JARDIANCE and may lead to
hospitalization. Tell your doctor if you have symptoms of a urinary
tract infection such as a burning feeling when passing urine, a
need to urinate often or right away, pain in the lower part of your
stomach or pelvis, or blood in the urine. Sometimes people also may
have a fever, back pain, nausea or vomiting.
- 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 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
- are going to have surgery
- are eating less due to illness, surgery, or a change in your
diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term ("binge" drinking)
- 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
- Drowsiness
- Weakness
- Dizziness
- Confusion
- Irritability
- Hunger
- Fast heartbeat
- Sweating
- Shaking or feeling jittery
- Kidney Problems. Sudden kidney injury has happened in
people taking JARDIANCE. Talk to your doctor right away if you
reduce the amount you eat or drink, or if you lose liquids; for
example, from vomiting, diarrhea, or being in the sun too
long.
- 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
and Patient Information.
JAR CONS ISI 1.11.17
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
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 top 20 pharmaceutical
companies. Headquartered in Ingelheim, Germany, the company operates globally with
approximately 50,000 employees. Since its founding in 1885, the
company has remained family-owned and today creates value through
innovation for three business areas including human
pharmaceuticals, animal health and biopharmaceutical contract
manufacturing.
Boehringer Ingelheim is committed to improving lives and
providing valuable services and support to patients and their
families. Our employees create and engage in programs that
strengthen our communities. Please visit our website to learn more
about how we make more health for more people through our Corporate
Social Responsibility initiatives.
In 2016, Boehringer Ingelheim achieved net sales of about
$17.6 billion (15.9 billion euros). R&D expenditure
corresponds to 19.6 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us,
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 wide range of therapies 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.
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 Jardiance 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 Jardiance 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® and EMPA-REG OUTCOME® are
registered trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-100131
CONTACT:
Lauren Murphy,
MBA
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: lauren.murphy@boehringer-ingelheim.com
Phone: (203) 448-1982
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