RIDGEFIELD, Conn., and
INDIANAPOLIS, June 13, 2017 /PRNewswire/ -- An analysis of
pooled safety data from 19 studies, including the EMPA-REG
OUTCOME® trial, involving more than 12,500 adults with
type 2 diabetes demonstrated treatment with Jardiance®
(empagliflozin) tablets (10 mg or 25 mg) was well tolerated, with
no imbalance in lower limb amputations or bone fractures compared
with placebo, Boehringer Ingelheim and Eli Lilly and Company (NYSE:
LLY) announced today. The analysis was published this month in
Advances in Therapy.
"This is an exciting time in the advancement of treatment
options for people living with type 2 diabetes and cardiovascular
disease," said Thomas Seck, M.D., vice president, Clinical
Development and Medical Affairs, Primary Care, Boehringer Ingelheim
Pharmaceuticals, Inc. "Boehringer Ingelheim and Lilly are committed
to providing available data about the efficacy and safety of our
treatment options. In this light, we are proud to share the most
comprehensive analysis of the safety data for Jardiance."
Jardiance is the first and only type 2 diabetes medicine
approved to reduce the risk of cardiovascular death in adults with
type 2 diabetes and established cardiovascular disease. The
landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced
the risk of cardiovascular death by 38 percent versus placebo in
people with type 2 diabetes and established cardiovascular disease
when added to standard of care (including glucose-lowering agents
and cardiovascular drugs). The overall safety profile of Jardiance
in EMPA-REG OUTCOME was consistent with that of previous
studies of Jardiance and current label information.
Pooled data for this analysis, which included 15 randomized
Phase I-III trials and four extension studies, were analyzed from
adults with type 2 diabetes treated with placebo (N=4203),
Jardiance 10 mg (N=4221) or Jardiance 25 mg (N=4196). Adverse
events were assessed in people who took at least one dose of
Jardiance or placebo.
The analysis demonstrated that the incidences of any adverse
events, severe adverse events, serious adverse events and adverse
events leading to discontinuation were no higher in adults treated
with Jardiance compared with those treated with placebo. The rate
of lower limb amputations was similar across treatment groups (1.1
percent in all treatment groups). In EMPA-REG OUTCOME, the
proportion of people with lower limb amputations was similar in
those treated with placebo (1.8 percent) and Jardiance (1.9
percent). The incidences of other events potentially related to
amputations (i.e., peripheral artery obstructive disease events,
diabetes foot-related events, relevant infections and wounds) were
similar in the placebo and Jardiance groups.
The incidence of bone fractures was also similar across
treatment groups (2.9, 2.8 and 2.5 percent in the placebo,
Jardiance 10 mg and Jardiance 25 mg groups, respectively). Events
consistent with genital infection occurred more frequently in
participants treated with Jardiance 10 mg and 25 mg (6.1 and 6.0
percent, respectively) than placebo (1.6 percent). The incidence of
events consistent with urinary tract infection was similar across
treatment groups (14.5-15.1 percent).
Jardiance was not associated with an increased risk of
hypoglycemia compared with placebo, except in those who were on
background sulfonylurea therapy (21.9, 24.5 and 23.4 percent in the
placebo, Jardiance 10 mg and Jardiance 25 mg groups,
respectively).
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 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.
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. 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 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
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 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-04689
CONTACT:
Lauren Murphy,
MBA
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: lauren.murphy@boehringer-ingelheim.com
Phone: (203) 448-1982
Grant
Smith
Communications
Lilly Diabetes
Email: grant.smith@lilly.com
Phone: (317) 954-9907
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visit:http://www.prnewswire.com/news-releases/jardiance-empagliflozin-analysis-reinforces-established-safety-profile-300473289.html
SOURCE Eli Lilly and Company; Boehringer Ingelheim