RIDGEFIELD, Conn. and
INDIANAPOLIS, June 14, 2016 /PRNewswire/ -- New data
showed Jardiance® (empagliflozin) reduced the risk for new-onset or
worsening kidney disease by 39 percent versus placebo when added to
standard of care in adults with type 2 diabetes with established
cardiovascular disease. Boehringer Ingelheim and Eli Lilly and
Company (NYSE: LLY) announced today that the findings have been
published in The New England Journal of Medicine and also
presented at the American Diabetes Association (ADA) 76th
Scientific Sessions® in New
Orleans.
"These findings are clinically important, given that more than a
third of people with type 2 diabetes will develop kidney disease,
which can lead to kidney failure and eventually the need for
dialysis. In the United States,
the cost to treat chronic kidney disease is estimated to exceed
$48 billion annually," said
Christoph Wanner, M.D., chief of the
Division of Nephrology and Hypertension at the University Hospital
of Würzburg, Germany. "Since
diabetes is the number one cause of kidney failure in the U.S.,
novel treatments that may have the potential to help address this
crucial medical need are necessary."
These findings were part of a pre-specified exploratory analysis
plan of additional endpoints of the landmark EMPA-REG OUTCOME®
trial. New-onset or worsening kidney disease was a pre-specified
composite endpoint that included the below clinical events.
Compared with placebo, JARDIANCE led to the following statistically
significant changes in outcomes:
- 55 percent reduction in the initiation of renal replacement
therapy (such as dialysis)
- 44 percent reduction in doubling of creatinine (a waste product
usually filtered by the kidneys) in the blood
- 38 percent reduction in progression to macroalbuminuria (very
high levels of a protein called albumin in the urine)
JARDIANCE also significantly slowed the decline in kidney
function over time compared with placebo. Most patients in this
trial were already taking the recommended standard treatment for
kidney disease in type 2 diabetes, renin angiotensin aldosterone
system blockade; the renal effects of JARDIANCE were apparent on
top of these agents.
Consistent risk reductions in kidney outcomes with JARDIANCE
were seen in adults who had impaired kidney function, or increased
levels of albumin in the urine, at baseline and in those who did
not, according to a post hoc sub-group analysis. Serious adverse
events (AEs) and AEs leading to treatment discontinuation for
JARDIANCE versus placebo were comparable for those with or without
impaired kidney function at baseline. Death due to renal disease
was rare and occurred in three patients treated with JARDIANCE (0.1
percent) and none treated with placebo.
"With these new EMPA-REG OUTCOME data, JARDIANCE is the only
SGLT2 inhibitor associated with evidence of slowing the progression
of kidney disease in adults with type 2 diabetes and established
cardiovascular disease in a cardiovascular outcome study," said
Professor Hans-Juergen Woerle,
global vice president medicine, Boehringer Ingelheim.
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 (CV) 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 CV drugs (including for blood pressure
and cholesterol). The primary endpoint was defined as time to first
occurrence of CV death, non-fatal heart attack or non-fatal
stroke.
Over a median of 3.1 years, JARDIANCE significantly reduced the
risk of CV death, non-fatal heart attack or non-fatal stroke by 14
percent versus placebo. Risk of CV death was reduced by 38 percent,
with no significant difference in the risk of non-fatal heart
attack or non-fatal stroke.
The overall safety profile of JARDIANCE in the EMPA-REG OUTCOME
trial was consistent with that of previous trials.
About Diabetes and Cardiovascular Disease
Approximately 29 million Americans and an estimated 415 million
people worldwide have diabetes, and nearly 28 percent of Americans
with diabetes—totaling 8 million people—are undiagnosed. In the
U.S., approximately 12 percent of those aged 20 and older have
diabetes. Type 2 diabetes (T2D) 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 either 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 (CV)
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 CV disease than people without
diabetes. In 2015, diabetes caused 5 million deaths worldwide, with
CV disease as the leading cause. Approximately 50 percent of
deaths in people with T2D worldwide are caused by CV disease. In
the U.S., health care costs for managing cardiovascular conditions
in patients with diabetes totalled more than $23 billion dollars in 2012.
About Diabetes and Kidney Disease
Kidney disease
develops in approximately 35 percent of patients with type 2
diabetes (T2D) and is associated with increased risk of death.
Long-term kidney problems, known as chronic kidney disease, can
lead to kidney failure in its final stages and typically
necessitates either dialysis or a kidney transplant. Nearly 44
percent of new cases of kidney failure are due to diabetes, and up
to 40 percent of people with T2D in the U.S. will eventually suffer
from kidney failure.
What is JARDIANCE?
JARDIANCE is a prescription
medicine used along with diet and exercise to lower blood sugar in
adults with type 2 diabetes. 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 can be life threatening and may need to be treated in
the hospital. 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 heart beat
- Sweating
- Shaking or feeling jittery
- Kidney Problems, especially in people 75 years of age or
older and people who already have kidney problems
- 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,
including Patient Information.
JAR CONS ISI 12.8.15
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 Pharmaceuticals,
Inc.
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 more than 47,000 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 dollars (14.8 billion euros). R&D expenditure
corresponds to 20.3 percent of its net sales.
For more information please
visit www.us.boehringer-ingelheim.com, 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 broad and
growing product portfolio 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
or follow @LillyDiabetes.
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 as a treatment for patients with type
2 diabetes along with diet and exercise 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® is a registered trademark of Boehringer Ingelheim
P-LLY
PC-JAR-0012-PR
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