RIDGEFIELD, Conn. and
INDIANAPOLIS, June 12, 2016
/PRNewswire/ -- New analyses showed risk reductions were consistent
across age groups for cardiovascular (CV) outcomes, including CV
death, with Jardiance® (empagliflozin) compared with placebo when
added to standard of care in adults with type 2 diabetes (T2D) and
established CV disease. These data, which were presented at the
American Diabetes Association (ADA) 76th Scientific
Sessions® in New Orleans, are from
the Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)
EMPA-REG OUTCOME® trial.
"As people with type 2 diabetes age, their risk for
cardiovascular events increases," said lead investigator of the
trial Bernard Zinman, M.D.,
director, Diabetes Centre, Mount Sinai Hospital; senior scientist,
Lunenfeld Tanenbaum Research Institute, and professor of medicine,
University of Toronto, Canada. "These
sub-analyses suggest that empagliflozin is associated with reducing
cardiovascular events regardless of age when starting treatment.
These data provide additional information about the EMPA-REG
OUTCOME trial."
Data presented at the ADA Scientific Sessions examined the
effect of treatment with JARDIANCE by age in the EMPA-REG OUTCOME
trial. Trial participants were grouped based on their age at
baseline: under 65 years, from 65 to 74, and 75 years and older.
Consistent reduction in the risk of CV death was seen independent
of age groups. Further analysis demonstrated similar
consistency by age group in reducing risk for hospitalization for
heart failure, as well as for the combination of hospitalization
for heart failure or CV death. Adverse events were consistent
with the known safety profile of JARDIANCE.
Furthermore, the reduction in risk for CV events did not differ
among sub-groups of adults in the EMPA-REG OUTCOME trial based on
their LDL ("bad") cholesterol levels at baseline (<70 mg/dL;
70-<85 mg/dL; 85-<100 mg/dL; 100-115 mg/dL; and >115
mg/dL). The risk reduction with JARDIANCE was consistent across the
LDL sub-groups (indicated by a lack of statistical interaction by
sub-group) for the combination of CV death, non-fatal heart attack
or non-fatal stroke, as well as for the individual outcomes of CV
death, hospitalization for heart failure and death from any
cause.
"These analyses from the landmark EMPA-REG OUTCOME trial further
demonstrate that JARDIANCE reduced the risk of cardiovascular death
and hospitalization for heart failure in adults with type 2
diabetes," said Professor Hans-Juergen
Woerle, global vice president medicine, Boehringer
Ingelheim. "Through our ongoing research, the BI-Lilly Diabetes
alliance is proud to continue to advance the understanding of how
to improve the management of cardiovascular risk in this
population."
Additional insight into the EMPA-REG OUTCOME findings will be
presented at an ADA Scientific Sessions symposium on Tuesday, June 14 at 8:00
a.m. CT.
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 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 totaled more than $23 billion dollars in 2012.
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.
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 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 their
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.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-0010-PR
CONTACT:
Lauren Murphy,
MBA
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: lauren.murphy@boehringer-ingelheim.com
Phone: (203) 448-1982
Molly
McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478-5423
Logo -
http://photos.prnewswire.com/prnh/20110825/DE57898LOGO
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/new-jardiance-empagliflozin-data-show-that-reduced-risk-for-cardiovascular-cv-death-was-consistent-across-age-groups-in-adults-with-type-2-diabetes-300283296.html
SOURCE Eli Lilly and Company; Boehringer Ingelheim