RIDGEFIELD,
Conn., Feb.
24, 2017 /PRNewswire/ -- Boehringer
Ingelheim Pharmaceuticals, Inc. today announced results
from a real-world analysis showing that Pradaxa®
(dabigatran etexilate mesylate) was associated with an improvement
in safety and efficacy outcomes compared to warfarin in patients
with non-valvular atrial fibrillation (NVAF). The results were
presented at the International Stroke Conference.
The study analyzed 7,245 PRADAXA and 14,490
warfarin patients with NVAF who had no prior use of an oral
anticoagulant (OAC), using data from an administrative claims
database from October 1,
2010, to April 30, 2014. The
patients were mostly male (56%), with a mean age of 74 years, and
mean CHADS2 stroke risk score of 2.2.
Compared to warfarin, PRADAXA was associated with a 26
percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a
20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl,
0.69-0.92). PRADAXA was also associated with a lower risk for
serious secondary outcomes, including a 68 percent reduced risk of
hemorrhagic stroke (HR, 0.32; 95% Cl, 0.14-0.76), an 18 percent
reduced risk of major extracranial bleeding (HR, 0.82; 95% Cl,
0.70-0.96), a 48 percent reduced risk of venous thromboembolism
(HR, 0.52; 95% Cl, 0.38-0.70), and a 27 percent reduced risk of
death (HR, 0.73; 95% Cl, 0.61-0.88).
"By combining our deep understanding
of the patient journey with access to robust real-world data, we
are improving the understanding of treatment for patients with
chronic conditions such as NVAF," said Sabine Luik, M.D., senior
vice president, Medicine & Regulatory Affairs, Boehringer
Ingelheim Pharmaceuticals, Inc. "These data offer
valuable real-world insights on patient outcomes, and are an
important complement to our robust clinical trial program, in which
PRADAXA demonstrated superior efficacy and a favorable risk-benefit
profile compared to warfarin."
About Pradaxa® (dabigatran etexilate mesylate)
capsules
What is PRADAXA?
PRADAXA is a prescription blood thinner medicine that
lowers the chance of blood clots forming in your body. PRADAXA is
used to:
- reduce the risk of stroke and blood clots in people who
have a medical condition called atrial fibrillation not caused by a
heart valve problem. With atrial fibrillation, part of the heart
does not beat the way it should. This can lead to blood clots
forming and increase your risk of a stroke.
- treat blood clots in the veins of your legs (deep vein
thrombosis) or lungs (pulmonary embolism) and reduce the risk of
them occurring again.
PRADAXA is not for use in people with artificial
(prosthetic) heart valves.
IMPORTANT SAFETY INFORMATION ABOUT
PRADAXA
For people taking PRADAXA for atrial
fibrillation: Do not stop taking PRADAXA without talking to
the doctor who prescribes it for you. Stopping PRADAXA increases
your risk of having a stroke. PRADAXA may
need to be stopped prior to surgery or a medical or dental
procedure. Your doctor will tell you when you should stop taking
PRADAXA and when you may start taking it again. If you have to stop
taking PRADAXA, your doctor may prescribe another medicine to help
prevent a blood clot from forming.
PRADAXA can cause bleeding which can be serious and
sometimes lead to death. Don't take PRADAXA if
you:
- currently have abnormal
bleeding;
- have ever had an allergic
reaction to it;
- have had or plan to have
a valve in your heart replaced
Your risk of bleeding with PRADAXA may be higher if
you:
- are 75 years old or older
- have kidney problems
- have stomach or intestine bleeding that is recent or
keeps coming back or you have a stomach ulcer
- take other medicines that increase your risk of bleeding,
like aspirin products, non-steroidal anti-inflammatory drugs
(NSAIDs) and blood thinners
- have kidney problems and take dronedarone
(Multaq®) or ketoconazole tablets
(Nizoral®)
Call your doctor or seek immediate medical care if you
have any of the following signs or symptoms of
bleeding:
- any unexpected, severe, or uncontrollable bleeding; or
bleeding that lasts a long time
- unusual or unexpected bruising
- coughing up or vomiting blood; or vomit that looks like
coffee grounds
- pink or brown urine; red or black stools (looks like
tar)
- unexpected pain, swelling, or joint pain
- headaches and feeling dizzy or weak
Spinal or epidural blood clots (hematoma).
People who take PRADAXA and have medicine injected into their
spinal and epidural area, or have a spinal puncture have a risk of
forming a blood clot that can cause long-term or permanent loss of
the ability to move (paralysis). Your risk of developing a spinal
or epidural blood clot is higher if:
- a thin tube called an epidural catheter is placed in your
back to give you certain medicine
- you take NSAIDs or a medicine to prevent blood from
clotting
- you have a history of difficult or repeated epidural or
spinal punctures
- you have a history of problems with your spine or have
had surgery on your spine.
If you take PRADAXA and receive spinal anesthesia or have
a spinal puncture, your doctor should watch you closely for
symptoms of spinal or epidural blood clots. Tell your doctor right
away if you have back pain, tingling, numbness, muscle weakness
(especially in your legs and feet), loss of control of the bowels
or bladder (incontinence).
Take PRADAXA exactly as prescribed.
It is important to tell your doctors about all medicines
(prescription and over-the-counter), vitamins, and supplements you
take. Some medicines may affect the way PRADAXA
works.
PRADAXA can cause indigestion, stomach upset or burning,
and stomach pain.
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.
Please see full Prescribing
Information and Medication
Guide.
About Boehringer Ingelheim
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 about 50,000 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.boehringer-ingelheim.us, or follow us on Twitter
@BoehringerUS.
COPYRIGHT ©2016 BOEHRINGER INGELHEIM PHARMACEUTICALS,
INC. ALL RIGHTS
RESERVED. 2/17 PC-01999
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