RIDGEFIELD, Conn. and
INDIANAPOLIS, April 16, 2018 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced an
academic collaboration with the University of
Oxford to investigate the effects of Jardiance®
on the progression of kidney disease and the occurrence of
cardiovascular death, in adults with established chronic kidney
disease with and without diabetes. EMPA-KIDNEY will be
independently conducted, analyzed and reported by the Medical
Research Council Population Health Research Unit at the
University of Oxford (MRC PHRU), which
is based in the Clinical Trial Service Unit and Epidemiological
Studies Unit (CTSU), in partnership with the Duke Clinical Research
Institute. Boehringer Ingelheim and Lilly will provide the funding
for the study.
The plan to conduct a dedicated outcomes study in adults with
chronic kidney disease is based on insights previously obtained
from the EMPA-REG OUTCOME® trial. This landmark
trial investigated the effect of Jardiance, when added to the
standard of care, on cardiovascular outcomes in adults with type 2
diabetes and established cardiovascular disease, compared with
placebo. Approximately one third of patients in the EMPA-REG
OUTCOME trial also had established chronic kidney disease at
baseline. A secondary exploratory endpoint of the study provided
promising data relating to the reduction in the relative risk of
new onset or worsening kidney disease. EMPA-KIDNEY will help
further our understanding of these data.
"We need to explore new treatment options that can help slow the
progression of chronic kidney disease, given that 30 million adults
in the United States are living
with this condition," said Jennifer
Green, M.D., endocrinologist and associate professor of
medicine at the Duke Clinical Research Institute, which is
responsible for U.S. trial operations. "The EMPA-REG OUTCOME trial
findings prompted us to explore further the effects of
empagliflozin on the risk of new or worsening kidney disease in
adults with type 2 diabetes and established cardiovascular disease.
Now, EMPA-KIDNEY will examine whether empagliflozin has the
potential to be a new treatment option for people with chronic
kidney disease."
EMPA-KIDNEY will include approximately 5,000 adults with
established chronic kidney disease, with and without diabetes. The
primary outcome of the study is to assess the effect of Jardiance
on time to clinically relevant kidney disease progression or
cardiovascular death. The study will be part of the empagliflozin
clinical development program, the largest clinical development
program of an SGLT2 inhibitor.
"Boehringer Ingelheim and Lilly are committed to exploring how
Jardiance can potentially fill gaps where unmet treatment needs
exist," said Thomas Seck, M.D., vice president of Clinical
Development and Medical Affairs – Primary Care, Boehringer
Ingelheim Pharmaceuticals, Inc. "Given the institution's knowledge
and history of prestigious research in chronic kidney disease, we
are excited to collaborate with the University
of Oxford on this initiative to help address a pressing need
for people with chronic kidney disease."
"The EMPA-KIDNEY study, which will build on results of the
EMPA-REG OUTCOME trial, will continue to expand our understanding
of how Jardiance can impact the lives of a broad range of people
with and without diabetes," said Jeff
Emmick, M.D., Ph.D., vice president, Product Development,
Lilly Diabetes. "We look forward to this new partnership and the
opportunity to follow the progress of the EMPA-KIDNEY study."
About the MRC PHRU at the University of
Oxford
The focus of MRC PHRU at the University of Oxford
(https://www.mrc-phru.ox.ac.uk/), which is led by Professor
Colin Baigent, is to improve
treatment and prevention of chronic diseases, particularly
cardiovascular disease and metabolic disease (e.g. diabetes
mellitus and chronic kidney disease), which collectively account
for a large proportion of premature adult deaths and the burden of
disability worldwide. MRC PHRU leads innovative clinical trials and
meta-analyses to identify important advances that could have a
major impact on health. Its worldwide approach, involving the study
of large numbers of people, provides reliable information about the
causes of disease and the effects of treatments, which can have a
major impact on global health.
About EMPA-KIDNEY: The study of heart and kidney
protection with empagliflozin
EMPA-KIDNEY is a multinational
randomized, double-blind, placebo-controlled clinical trial. It is
designed to evaluate the effect of empagliflozin on clinically
relevant outcomes: kidney disease progression and cardiovascular
mortality risk. The primary outcome is defined as time to a first
event of either a cardiovascular death or kidney disease
progression, defined as end stage kidney disease (the need for
kidney replacement therapy such as, dialysis or kidney
transplantation), a sustained decline in eGFR to
<10mL/min/1.73m2, renal
death or a sustained decline of ≥40% in eGFR from randomization.
EMPA-KIDNEY will include people with established chronic kidney
disease both with and without diabetes receiving current standard
of care.
The study will be conducted in selected countries representing a
global footprint and aims to randomize approximately 5,000
participants to receive either empagliflozin 10 mg once daily or
placebo, on top of standard of care.
About Chronic Kidney Disease
Chronic kidney disease
is defined as a progressive decline of kidney function over time.
About two thirds of chronic kidney disease cases are attributable
to metabolic diseases such as diabetes, hypertension and obesity.
Notably, chronic kidney disease is associated with increased
morbidity and mortality. The majority of deaths among people with
chronic kidney disease occur as a result of cardiovascular
complications, often before reaching end stage renal disease.
Chronic kidney disease affects approximately 15 percent of adults
in the United States and treatment
costs are estimated to exceed $48
billion annually. Since there are currently only few
treatment options, the overarching unmet medical need for new
treatment options in chronic kidney disease is evident.
About EMPA-REG OUTCOME®
(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.
Although the EMPA-REG OUTCOME trial was not designed to assess
the potential mechanisms behind the effect of Jardiance on kidney
outcomes, the kidney assessment was part of a pre-specified
exploratory analysis plan of additional endpoints.
The overall safety profile of Jardiance was consistent with that
of previous trials.
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 chronic kidney disease 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-100312
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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