RIDGEFIELD, Conn. and
INDIANAPOLIS, March 6, 2018 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced
plans to expand their clinical trial program for
Jardiance® in chronic heart failure with the EMPERIAL
clinical trials. These trials will evaluate the effect of Jardiance
on exercise ability and heart failure symptoms in people with
chronic heart failure independent of whether they have type 2
diabetes. EMPERIAL comprises two Phase III trials that will assess
the effect of 12 weeks of treatment with Jardiance on the ability
of people with heart failure to perform daily exercise.
The plans for the EMPERIAL trials follow initiation of the
EMPEROR trials in March 2017. While
the EMPEROR outcome trials focus on long-term morbidity and
mortality outcomes in people with heart failure, the EMPERIAL
functional trials will investigate possible benefits on exercise
capacity and heart failure symptoms. These studies are based
on data obtained from the landmark EMPA-REG OUTCOME®
trial, where the effect of Jardiance on heart failure outcomes was
evaluated.
"Symptoms of heart failure can have a profound effect on quality
of life, with more than three-quarters of people with heart failure
finding it difficult to carry out routine activities," said
Jeff Emmick, M.D., Ph.D., vice
president, Product Development, Lilly Diabetes. "Currently, there
are limited treatment options that can help improve the everyday
lives of people living with chronic heart failure. We look forward
to seeing whether Jardiance can help address this unmet need."
Heart failure is a serious condition where the heart is unable
to pump enough blood around the body. It affects 26 million people
worldwide, including more than 6 million Americans, and is
associated with high morbidity and mortality. Approximately 50
percent of people who develop heart failure die within five years,
and it is a leading cause of hospitalization in the United States and Europe.
"Boehringer Ingelheim and Lilly are committed to exploring how
Jardiance can improve patient health outcomes and fill treatment
gaps to serve as a broad cardiometabolic treatment option," said
Thomas Seck, M.D., vice president of Clinical Development and
Medical Affairs – Primary Care, Boehringer Ingelheim
Pharmaceuticals, Inc. "We were encouraged by the heart failure
findings with Jardiance in the EMPA-REG OUTCOME trial and look
forward to the additional data from our other ongoing trials."
About EMPERIAL
EMPERIAL consists of two Phase III
randomized, double-blind trials. The trials evaluate the effect of
12 weeks' treatment of once-daily Jardiance 10 mg compared with
placebo on exercise ability and heart failure symptoms in patients
with chronic heart failure with preserved or reduced ejection
fraction.* This will be measured by the 6-minute walk test, a
common measure of functional exercise capacity.
- EMPERIAL-preserved [NCT03448406]: will investigate
Jardiance in patients with chronic heart failure with preserved
ejection fraction (HFpEF). The study looks at a functional endpoint
— how far patients can walk in 6 minutes — and at heart failure
symptoms.
-
- Primary endpoint: Change from baseline to week 12 in exercise
capacity as measured by the distance walked in 6 minutes
- Anticipated number of patients: approx. 300
- Estimated completion: 2019
- EMPERIAL-reduced [NCT03448419]: will investigate
Jardiance in patients with chronic heart failure with reduced
ejection fraction (HFrEF). The study looks at a functional
endpoint — how far patients can walk in 6 minutes — and at heart
failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise
capacity as measured by the distance walked in 6 minutes
- Anticipated number of patients: approx. 300
- Estimated completion: 2019
*Ejection fraction is a measurement of the
percentage of blood leaving the heart each time it contracts.
During each heartbeat pumping cycle, the heart contracts and
relaxes. When the heart contracts, it ejects blood from the two
pumping chambers (ventricles). When the heart relaxes, the
ventricles refill with blood.
HFpEF occurs when the heart muscle contracts
normally but the ventricle muscles are stiff. They do not relax as
they should when the ventricle fills with blood, so less blood can
enter the heart compared to a normally functioning heart.
HFrEF occurs when the heart muscle does not contract
effectively and less blood is pumped out to the body compared to a
normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure,
specifically difficulty breathing, swelling and fatigue.
About Heart Failure
Heart failure is a progressive,
debilitating and potentially fatal condition that occurs when the
heart cannot pump enough blood around the body. Symptoms of heart
failure include difficulty breathing, swelling — most commonly in
feet, legs and ankles — and fatigue, among others. Heart failure is
a prevalent disease; 26 million people around the world and more
than 6 million people in the United
States have chronic heart failure. There is a high
unmet need in the treatment of heart failure, as approximately 50
percent of people diagnosed with heart failure will die within five
years. Additionally, heart failure represents the most common cause
of hospitalization among individuals aged 65 years and over in
the United States and
Europe. Heart failure is highly prevalent in people with
diabetes, but approximately half of all people with heart failure
do not have 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.
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 plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your doctor right away if you become
pregnant during treatment with JARDIANCE.
- are breastfeeding, or plan to breastfeed. JARDIANCE may pass
into your breast milk and may harm your baby. Do not breastfeed
while taking JARDIANCE.
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.
- Allergic (hypersensitivity) reactions. Symptoms of
serious allergic reactions to JARDIANCE may include:
-
- swelling of your face, lips, throat and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms,
stop taking JARDIANCE and contact your doctor or go to the nearest
emergency room right away.
- 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.
CL-JAR-100002 12.19.17
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 the expansion of clinical trials to evaluate
Jardiance as a treatment for adults with heart failure 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-100250
CONTACT:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Grant Smith
Communications
Lilly Diabetes
Email: grant.smith@lilly.com
Phone: (317) 954-9907
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SOURCE Eli Lilly and Company; Boehringer Ingelheim