RIDGEFIELD, Conn., and
INDIANAPOLIS, Nov. 13, 2016 /PRNewswire/ -- New data presented
today at the American Heart Association Scientific Sessions
2016 showed that Jardiance® (empagliflozin) tablets
consistently reduced the risk for cardiovascular death, regardless
of the type of cardiovascular disease at baseline, compared with
placebo when added to standard of care in adults with type 2
diabetes and established cardiovascular disease. The findings are
part of the landmark EMPA-REG OUTCOME® trial, which is
the first trial of a diabetes medication to show a reduction in
cardiovascular death in adults with type 2 diabetes and established
cardiovascular disease. This study is supported by Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY).
"Cardiovascular disease is two to four times more common in
people with type 2 diabetes and is an umbrella term consisting of
several different vascular outcomes, including heart attack, heart
failure, peripheral vascular disease and stroke," said lead
investigator of the trial Bernard
Zinman, M.D., director, Diabetes Centre, Mount Sinai
Hospital, Toronto; senior
scientist, Lunenfeld Tanenbaum Research Institute, and professor of
medicine, University of Toronto. "Since
approximately two out of three deaths in people with type 2
diabetes in the U.S. are attributed to cardiovascular causes, we
need diabetes therapies that help reduce this complication in
individuals who have an underlying cardiovascular issue."
For this post hoc analysis, trial participants were grouped
based on type of cardiovascular disease at baseline, which included
history of heart attack, stroke, heart failure, atrial fibrillation
and existing peripheral artery disease. Lower rates of
cardiovascular death were seen in the JARDIANCE group independent
of cardiovascular disease type. Observed adverse events were
consistent with the known safety profile of JARDIANCE.
"JARDIANCE is the only oral type 2 diabetes medicine shown in a
clinical trial to reduce the risk of cardiovascular death," said
Professor Hans-Juergen Woerle,
global vice president medicine, Metabolism, Boehringer Ingelheim.
"These results provide further evidence and reinforce the strength
of the EMPA-REG OUTCOME data demonstrating a reduction in risk of
cardiovascular death in adults with type 2 diabetes and established
cardiovascular disease."
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.
Over a median of 3.1 years, JARDIANCE significantly reduced the
risk of cardiovascular death, non-fatal heart attack or non-fatal
stroke by 14 percent versus placebo. Risk of cardiovascular 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 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
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 cardiovascular disease than people
without diabetes. Approximately 50 percent of deaths in people with
type 2 diabetes worldwide and 68 percent of deaths in people with
type 2 diabetes in the U.S. are caused by cardiovascular
disease. In the U.S., health care costs for managing
cardiovascular conditions in patients with diabetes totaled more
than $23 billion in 2012.
Having diabetes can shorten a person's lifespan by as much as
six years compared with someone without diabetes.* And having both
diabetes and a history of heart attack or stroke can shorten a
person's lifespan by as much as 12 years compared with someone
without these conditions.**
* Based on having a history of diabetes at age 60.
** Based on having a history of diabetes and heart attack or stroke
at age 60.
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 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 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 7.18.16
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 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 (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 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 JARDIANCE as a treatment of adults
with type 2 diabetes and established cardiovascular 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
PC-JAR-0040-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/20031219/LLYLOGO
Logo -
http://photos.prnewswire.com/prnh/20110825/DE57898LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/jardiance-empagliflozin-consistently-reduced-the-risk-of-cardiovascular-death-in-adults-with-type-2-diabetes-regardless-of-the-type-of-cardiovascular-disease-at-baseline-300361702.html
SOURCE Eli Lilly and Company