RIDGEFIELD, Conn. and
INDIANAPOLIS, March 17, 2017 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced
that the EMPEROR HF clinical trial program was initiated.
EMPEROR HF comprises two phase III outcome studies that will
investigate empagliflozin for the treatment of adults with chronic
heart failure. The trials will involve not only adults with type 2
diabetes who have heart failure, but also heart failure patients
who do not have diabetes.
Heart failure is a condition where the heart cannot pump enough
blood around the body, and is associated with high morbidity and
mortality. Approximately 26 million people worldwide, and 5.7
million people in the U.S. suffer from heart failure. It is the
leading cause of hospitalizations in the
United States and Europe,
with more than 1 million admissions annually for heart failure as
the primary diagnosis. Readmission rates after a hospital stay for
heart failure are as high as 30 percent within 60 to 90 days, and
approximately 50 percent of patients diagnosed with heart failure
will die within five years.
"Heart failure is a global health burden. We need to explore new
treatment options, especially for those types of heart failure
where treatments are currently limited," said Professor
Milton Packer, MD, Baylor Heart and Vascular Institute,
Baylor University Medical Center,
USA, lead investigator of both
trials. "The EMPA-REG OUTCOME® trial demonstrated a
significant reduction in the risk of cardiovascular death with
empagliflozin in adults with type 2 diabetes and cardiovascular
disease. And now these new EMPEROR HF clinical trials will
take a dedicated look at the effects of empagliflozin in heart
failure patients."
Jardiance® (empagliflozin) is the first type 2
diabetes medicine approved by the U.S. Food and Drug Administration
(FDA) to reduce the risk of cardiovascular death in adults with
type 2 diabetes and established cardiovascular disease. EMPA-REG
OUTCOME demonstrated that JARDIANCE reduced the risk of
cardiovascular death by 38 percent versus placebo in patients with
type 2 diabetes and established cardiovascular disease when added
to standard of care (including glucose-lowering agents and
cardiovascular drugs). As one of the secondary endpoints, the trial
also showed a reduction in the risk of hospitalization for heart
failure by 35 percent with JARDIANCE in this patient population.
These data are not included in the current JARDIANCE
label.
Heart failure can be categorized by ejection fraction, a
measurement used to determine how well the heart pumps blood around
the body. The EMPEROR HF program consists of two event-driven phase
III clinical trials that will investigate empagliflozin for the
treatment of adults with chronic heart failure with either
preserved ejection fraction or reduced ejection fraction. Both
trials will assess the impact of treatment with empagliflozin on
cardiovascular death and hospitalization for heart failure as
primary endpoints. The two trials will involve approximately 7,000
patients in total and are anticipated to complete in 2020.
"Despite currently available therapies, about half of people who
develop heart failure die within 5 years of diagnosis. This
highlights a real need for progress in the treatment of this
condition," said Prof. Hans-Juergen
Woerle, Global Vice President Medicine, Therapeutic Area
Metabolism, Boehringer Ingelheim. "Our new studies aim to explore
the potential of empagliflozin for patients affected by heart
failure. At the same time, these studies mark the first time
empagliflozin will be evaluated in people without type 2 diabetes.
So we are very excited about the initiation of these two new
studies."
JARDIANCE is not for people with type 1 diabetes or people
with diabetic ketoacidosis (increased ketones in the blood or
urine).
About the EMPEROR HF Clinical Trial Program
The EMPEROR (EMPagliflozin outcomE tRial in patients with
chrOnic heaRt failure) HF clinical trial program will investigate
once daily empagliflozin compared with placebo in heart failure
patients both with and without type 2 diabetes receiving current
standard of care. The program comprises the following two phase
III, randomized, double-blind trials which assess heart failure in
patients with preserved ejection fraction or patients with reduced
ejection fraction*:
- EMPEROR HF-Preserved [NCT03057951]: will
investigate the safety and efficacy of empagliflozin in patients
with chronic heart failure with preserved ejection fraction
(HFpEF).
- Primary endpoint: time to first event of adjudicated
cardiovascular death or adjudicated hospitalization for heart
failure (HHF) [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 4,100
- Estimated completion: 2020
- EMPEROR HF-Reduced [NCT03057977]: will investigate the
safety and efficacy of empagliflozin in patients with chronic heart
failure with reduced ejection fraction (HFrEF).
- Primary endpoint: time to first event of adjudicated
cardiovascular death or adjudicated HHF [Time Frame: up to 38
months]
- Anticipated number of patients: approx. 2,800
- Estimated completion: 2020
*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 with a normally functioning heart.
HFrEF occurs when the heart muscle does not contract
effectively and less blood is pumped out to the body compared with
a normally functioning heart.
About Heart Failure
Heart failure is a debilitating and potentially fatal condition
that occurs when the heart cannot pump enough blood around the
body. Heart failure is a prevalent disease; 26 million people
around the world, and 5.7 million people in the U.S. have chronic
heart failure. There is a high unmet need in the treatment of heart
failure as there remains a significant morbidity and mortality
associated with the condition. Heart failure is the leading cause
of hospitalization in the United
States and Europe, with
over 1 million admissions. Readmission rates after a hospital stay
for heart failure are as high as 30 percent within 60 to 90 days,
and approximately 50 percent of patients diagnosed with heart
failure will die within five years. Heart failure is highly
prevalent in patients with diabetes; however, approximately half of
all heart failure patients 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. 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 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with
145 affiliates and about 50,000 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 2015, Boehringer Ingelheim achieved net sales of about
$15.8 billion (14.8 billion euros). R&D expenditure
corresponds to 20.3 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
www.lilly.com/newsroom/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 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
PC-02802
CONTACT:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
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