RIDGEFIELD, Conn. and INDIANAPOLIS, May 26, 2020 /PRNewswire/ -- Boehringer Ingelheim
and Eli Lilly and Company (NYSE:LLY) today announced an academic
research collaboration with the Duke Clinical Research Institute
(DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention
of Chronic heart failure and morTality after an acute Myocardial
Infarction). The collaboration will investigate whether
Jardiance® (empagliflozin) can improve outcomes and
prevent heart failure in adults with and without diabetes who have
had an acute myocardial infarction, more commonly known as a heart
attack. This randomized clinical trial will be conducted, analyzed
and reported in partnership with the DCRI, with Boehringer
Ingelheim and Lilly providing funding.
EMPACT-MI will include approximately 3,300 adults across at
least 16 countries who have had an acute myocardial infarction. The
primary endpoint of the trial is to assess the effect of Jardiance
on all-cause mortality and hospitalization for heart failure. The
trial will be part of the EMPOWER program, the broadest and most
comprehensive clinical trial program exploring the impact of
Jardiance on the lives of people with cardio-renal-metabolic
conditions.
"This collaboration represents an important step in
understanding how to safeguard and protect the lives of patients
with acute myocardial infarction," said Adrian Hernandez, M.D., M.H.S., co-chair of the
EMPACT-MI trial and DCRI executive director. "Myocardial infarction
is the leading cause of death in cardiology, and this is the first
trial in the SGLT2 inhibitor class to investigate the potential to
increase survival and decrease progression to heart failure in
people who have had a recent myocardial infarction."
Javed Butler, M.D., M.P.H.,
M.B.A., chair of the EMPACT-MI trial and professor and
chairman of the Department of Medicine at the University of Mississippi, added, "We are delighted
to lead the EMPACT-MI trial to find out whether Jardiance could
become a new standard of care option to improve the outcomes and
lives of people with acute myocardial infarction."
Pragmatic clinical trials focus on the relationship between
treatments and outcomes in real-world health system practice. This
partnership will leverage the DCRI's experience in pragmatic trials
by implementing innovative and efficient trial elements, including
remote follow-up and a focused data collection approach, which
enable a strong patient focus while maintaining high data
quality.
"We are pleased to collaborate with the Duke Clinical Research
Institute on the EMPACT-MI trial to investigate the potential to
increase survival and prevent heart failure from developing in
adults who have had a heart attack. Despite current therapies,
these patients have a high residual risk that could be addressed by
the multiple benefits we have observed with SGLT2 inhibition,"
said Waheed Jamal, M.D., corporate vice president and head of
CardioMetabolic Medicine, Boehringer Ingelheim.
"The EMPACT-MI trial is part of our broad and comprehensive
clinical development program, which aims to explore how Jardiance
can improve health outcomes and fill therapeutic gaps for a broad
range of patients suffering from cardio-renal-metabolic
conditions," said Jeff Emmick, M.D.,
Ph.D., vice president, Product Development, Lilly.
About the Duke Clinical Research Institute
The DCRI,
part of the Duke University School of
Medicine, is the largest academic clinical research organization in
the world. Its mission is to develop and share knowledge that
improves the care of patients through innovative research. The
institute conducts groundbreaking multinational clinical trials,
manages major national patient registries, and performs landmark
outcomes research. DCRI research spans multiple disciplines, from
pediatrics to geriatrics, primary care to subspecialty medicine,
and genomics to proteomics. The DCRI also is home to the Duke
Databank for Cardiovascular Diseases, the largest and oldest
institutional cardiovascular database in the world, which continues
to inform clinical decision-making 40 years after its founding.
About EMPACT-MI
EMPACT-MI (EMPAgliflozin for
the prevention of Chronic heart failure and morTality after an
acute Myocardial Infarction) is a streamlined, randomized, blinded,
placebo-controlled, multi-center trial exploring the efficacy and
safety of Jardiance in adults hospitalized with an acute myocardial
infarction.
About EMPOWER
The EMPOWER program reinforces the
long-term commitment of Boehringer Ingelheim and Eli Lilly and
Company to improve outcomes for people living with cardiovascular
and renal disease. EMPOWER is one of the largest cardiovascular
clinical trial programs for an SGLT2 inhibitor to date with more
than 13,000 adults worldwide. The aim of the program is preventing
major clinical cardiovascular and renal outcomes that affect
millions of adults worldwide as well as families and healthcare
systems.
In addition to EMPACT-MI, the development program
encompasses:
- EMPEROR reduced, in adults with chronic heart failure with
reduced ejection fraction to prevent cardiovascular death and
hospitalization due to heart failure
- EMPEROR preserved, in adults with chronic heart failure with
preserved ejection fraction to prevent cardiovascular death and
hospitalization due to heart failure
- EMPULSE, in adults hospitalized for acute heart failure to
improve clinical and patient reported outcomes
- EMPA-KIDNEY, in adults with established chronic kidney disease
to reduce the progression of kidney disease and the occurrence of
cardiovascular death
- EMPERIAL reduced, in adults with chronic heart failure with
reduced ejection fraction to improve functional ability and patient
reported outcomes
- EMPERIAL preserved, in adults with chronic heart failure with
preserved ejection fraction to improve functional ability and
patient reported outcomes
- EMPA-REG OUTCOME®, in adults with type
2 diabetes and established cardiovascular disease to prevent major
adverse cardiovascular events, including cardiovascular death
- EMPRISE, a comparative effectiveness and safety study in
routine clinical care.
About Acute Myocardial Infarction
Ischemic heart
disease, including acute myocardial infarction (heart attack), is
the leading cause of death and disability in the United
States, with over 7 million acute myocardial infarctions
occurring every year around the world. People who suffer an acute
myocardial infarction are at a high risk of heart failure and
death. Heart attacks occur when the blood supply to an area of the
heart is blocked by a blood clot or by atherosclerosis (fatty
deposits or plaques lining vessel walls), causing heart tissue to
die. Rapid diagnosis and treatment to restore blood flow through
the affected vessel are vital to save as much of the heart tissue
as possible.
About Heart Failure
Heart failure is a progressive,
debilitating and potentially fatal condition that occurs when the
heart cannot supply adequate circulation to meet the body's demands
for oxygenated blood or to do so requires increased blood volume
leading to fluid accumulation (congestion) in the lungs and
peripheral tissues. It is a widespread condition affecting 60
million people worldwide and expected to increase as the population
ages. Heart failure is highly prevalent in people with diabetes;
however, approximately half of all people with heart failure do not
have diabetes.
The Jardiance heart failure program was initiated based on data
from the EMPA-REG OUTCOME trial, which 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. EMPA-REG OUTCOME
was the first SGLT2 inhibitor trial to show a relative risk
reduction in cardiovascular death in adults with type 2 diabetes
and established cardiovascular disease. This population was
comprised of more than 45% of adults with a prior myocardial
infarction.
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
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.
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 penis.
- 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. Ketoacidosis has also happened in people with diabetes
who were sick or who had surgery during treatment with JARDIANCE.
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
- 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.
- 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.
- 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
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals (perineum). This
bacterial infection has happened in women and men who take
JARDIANCE, and may lead to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have fever or
are feeling very weak, tired or uncomfortable (malaise), and you
develop any of the following symptoms in the area between and
around your anus and genitals: pain or tenderness, swelling, and
redness of skin (erythema).
- 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.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking 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. Your doctor may stop your JARDIANCE
before you have surgery. Talk to your doctor if you are having
surgery about when to stop taking JARDIANCE and when to start it
again
- are eating less or there is 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 are planning 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.
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 Prescribing
Information and Medication Guide.
CL-JAR-100057 01.27.2020
Boehringer Ingelheim and Eli Lilly and Company
In
January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance that centers on
compounds representing several of the largest diabetes treatment
classes. Depending on geographies, the companies either co-promote
or separately promote the respective molecules each contributing to
the alliance. The alliance leverages the strengths of two of the
world's leading pharmaceutical companies to focus on patient needs.
By joining forces, the companies demonstrate their commitment, not
only to the care of people with diabetes, but also to investigating
the potential to address areas of unmet medical need. Clinical
trials have been initiated to evaluate the impact of Jardiance on
people living with heart failure or chronic kidney disease.
About Boehringer Ingelheim
Making new and better
medicines for humans and animals is at the heart of what we do. Our
mission is to create breakthrough therapies that change lives.
Since its founding in 1885, Boehringer Ingelheim is independent and
family-owned. We have the freedom to pursue our long-term vision,
looking ahead to identify the health challenges of the future and
targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, more
than 51,000 employees create value through innovation daily for our
three business areas: Human Pharma, Animal Health, and
Biopharmaceutical Contract Manufacturing. In 2019, Boehringer
Ingelheim achieved net sales of around $21.3
billion (19 billion euros).
Our significant investment of over $3.9
billion (3.5 billion euros) in
R&D drives innovation, enabling the next generation of
medicines that save lives and improve quality of life.
We realize more scientific opportunities by embracing the power
of partnership and diversity of experts across the life-science
community. By working together, we accelerate the delivery of the
next medical breakthrough that will transform the lives of patients
now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
Ridgefield, CT, is the largest
U.S. subsidiary of Boehringer Ingelheim Corporation and is part of
the Boehringer Ingelheim group of companies. In addition, there are
Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont,
Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and
strengthening our communities. Please visit
www.boehringer-ingelheim.us/csr to learn more about Corporate
Social Responsibility initiatives.
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, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes and related conditions. We work to deliver breakthrough
outcomes through innovative solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/ or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
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 drug 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 a further discussion of these
and other risks and uncertainties that could cause actual results
to differ from Lilly's expectations, please see Lilly's most recent
Forms 10-K and 10-Q filed with the U.S. Securities and Exchange
Commission. Lilly undertakes no duty to update forward-looking
statements.
Jardiance® and EMPA-REG OUTCOME® are
registered trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-101254
CONTACT:
Sheryl van der Hilst
Senior
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: Sheryl.van_der_hilst@boehringer-ingelheim.com
Phone: (914) 772-7973
Stephan Thalen
Global Business
Communications
Lilly Diabetes and Lilly USA
Email: stephan.thalen@lilly.com
Phone: (317) 903-5640
Kaitlin Jansen
DCRI Communications
Email : kaitlin.jansen@duke.edu
Phone : +1 (704) 995 2384
Susan Landis
DCRI
Communications
Email : susan.landis@duke.edu
Phone : +1 (919) 668 5769
View original content to download
multimedia:http://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-to-collaborate-with-duke-clinical-research-institute-on-a-pragmatic-trial-examining-jardiances-effects-following-an-acute-myocardial-infarction-301064381.html
SOURCE Eli Lilly and Company