Pooled Analysis Confirms XARELTO® has Similar Efficacy and Reduces the
Incidence of Major Bleeding by Nearly Half Compared to Standard of Care in
Treatment of DVT and PE
Analysis Published in the Thrombosis Journal
RARITAN, N.J., Sept. 20, 2013
RARITAN, N.J., Sept. 20, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc.
(Janssen) announced today a newly published, pooled analysis of the Phase III
EINSTEIN trial program, showing XARELTO^® (rivaroxaban) is as effective as the
standard of care in reducing the risk of deep vein thrombosis (DVT) and
pulmonary embolism (PE) in people with symptomatic DVT or PE, while reducing
the incidence of major bleeding by 46 percent. The analysis also found safety
and efficacy outcomes for XARELTO^® were consistent across four subgroups of
participants: fragile subjects, those with cancer, subjects with a history of
a recurrent venous thromboembolism (VTE) and those presenting with a large
clot. These findings were published in Volume 11, Issue21 of the Thrombosis
DVT is a condition in which blood clots form in one of the large, deep veins,
usually in the legs. PE is a serious condition that most commonly occurs when
part or all of a DVT dislodges and travels to the lung, via the heart, where
it can partially or completely block a branch of the pulmonary artery. When PE
occurs with large clots, multiple clots, or when the patient already has
pre-existing heart or lung disease, the event may be fatal. Each year up to
900,000 Americans experience a DVT or PE, resulting in up to 300,000 deaths.
"The current standard of care for treatment of DVT and PE requires a two-drug
regimen: a rapidly acting, injectable anticoagulant followed by long-term
treatment with an oral Vitamin K antagonist, such as warfarin," said Jack E.
Ansell, M.D., MACP, Professor of Medicine at New York University School of
Medicine*. "This analysis confirms an oral, single-drug option like XARELTO^®
can simplify treatment and has a lower incidence of major bleeding compared to
standard of care. It effectively reduces the risk of DVT and PE while
eliminating the need for routine blood monitoring and frequent dose
This pre-specified pooled analysis included results from the EINSTEIN-DVT and
EINSTEIN-PE studies. The analysis included more than 8,000 participants, split
between the DVT (3,449) and PE (4,833) studies, indicating the XARELTO^®
treatment benefit can be expected for subjects with either condition. Results
from this pooled analysis were presented at the 54^th American Society of
Hematology (ASH) Annual Meeting in Atlanta in December 2012.
XARELTO^® is the most-prescribed novel oral anticoagulant in the U.S. market
today and is approved for six clinical uses in the U.S. It has earned the
broadest reimbursement profile among novel anticoagulants, with 85 percent of
patients on Medicare Part D and 85 percent of commercial patients covered at
the lowest branded co-pay. To date, more than 5 million patients have received
XARELTO^® worldwide and more than 3 million prescriptions have been written
for XARELTO^® in the U.S.
The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial.
The trial compared oral rivaroxaban – 15 mg twice daily for three weeks,
followed by 20 mg once daily – with the current standard of care (enoxaparin
followed by a Vitamin K Antagonist [VKA]) in subjects with acute symptomatic
PE with or without symptomatic DVT. Patients received treatment for six or 12
months. EINSTEIN-PE enrolled 4,833 participants and is the largest study ever
conducted in the acute treatment of PE. Results from EINSTEIN-PE were
presented at the American College of Cardiology Annual Scientific Sessions,
and published in the New England Journal of Medicine in March 2012 (n engl j
The EINSTEIN-DVT study compared the safety and efficacy of oral rivaroxaban
–administered at 15 mg twice daily for three weeks followed by 20 mg once
daily – with standard therapy. More than 3,400 participants with acute
symptomatic DVT in the deep veins of the knee or thigh, but without any
symptoms of PE, were enrolled and received treatment for three, six or 12
months. Results from EINSTEIN-DVT were presented at the annual European
Society of Cardiology Congress in August 2010.
This pooled analysis of the EINSTEIN-DVT and -PE studies was pre-specified to
be able to assess the overall efficacy and safety of XARELTO^® for the
treatment of VTE.
*Dr. Ansell was not associated with the EINSTEIN clinical trials and was not
compensated for any media work. He has been a paid consultant to Janssen
About XARELTO^® (rivaroxaban)
XARELTO^® works by blocking the blood clotting Factor Xa. XARELTO^® does not
require routine blood monitoring. Cardiologists start more patients on
XARELTO^® than any other anticoagulant and it is the only Factor Xa inhibitor
approved for six distinct uses:
1.To reduce the risk of blood clots in the legs and lungs of people who have
just had knee replacement surgery.
2.To reduce the risk of blood clots in the legs and lungs of people who have
just had hip replacement surgery.
3.To reduce the risk of stroke and blood clots in people with atrial
fibrillation, not caused by a heart valve problem. For patients currently
well managed on warfarin, there is limited information on how XARELTO^®
and warfarin compare in reducing the risk of stroke.
4.To treat people with deep vein thrombosis (DVT).
5.To treat people with pulmonary embolism (PE).
6.To reduce the risk of recurrence of DVT or PE following an initial six
months of treatment for acute venous thromboembolism.
The extensive program of clinical trials evaluating rivaroxaban makes the
compound the most studied oral, Factor Xa inhibitor in the world today. By the
time of its completion in 2018, more than 100,000 patients will have
participated in EXPLORER, a comprehensive, global research program for
Janssen Research & Development, LLC, and Bayer HealthCare together are
For more information about XARELTO^®, ^ visit www.xarelto-us.com. The
XARELTO^® CarePath™ Support Program is a resource designed for healthcare
providers, patients and caregivers.Visit www.xareltocarepath.com or call
1-888-XARELTO to learn more about the XARELTO^® CarePath™ resources focused on
access, education and adherence.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO^®?
oFor people taking XARELTO^® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) are at an
increased risk of forming a blood clot in the heart, which can travel to the
brain, causing a stroke, or to other parts of the body. XARELTO^® lowers
your chance of having a stroke by helping to prevent clots from forming. If
you stop taking XARELTO^®, you may have increased risk of forming a clot in
Do not stop taking XARELTO^® without talking to the doctor who prescribes it
for you. Stopping XARELTO^® increases your risk of having a stroke.
If you have to stop taking XARELTO^®, your doctor may prescribe another
blood thinner medicine to prevent a blood clot from forming.
oXARELTO^® can cause bleeding, which can be serious, and rarely may lead to
death. This is because XARELTO^® is a blood thinner medicine that reduces
blood clotting. While you take XARELTO^® you are likely to bruise more
easily and it may take longer for bleeding to stop.
You may have a higher risk of bleeding if you take XARELTO^® and take other
medicines that increase your risk of bleeding, including:
oAspirin or aspirin-containing products
oNon-steroidal anti-inflammatory drugs (NSAIDs)
oWarfarin sodium (Coumadin^®, Jantoven^®)
oAny medicine that contains heparin
oOther medicines to prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor or
pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these
signs or symptoms of bleeding:
oUnexpected bleeding or bleeding that lasts a long time, such as:
oNosebleeds that happen often
oUnusual bleeding from gums
oMenstrual bleeding that is heavier than normal, or vaginal bleeding
oBleeding that is severe or that you cannot control
oRed, pink, or brown urine
oBright red or black stools (looks like tar)
oCough up blood or blood clots
oVomit blood or your vomit looks like "coffee grounds"
oHeadaches, feeling dizzy or weak
oPain, swelling, or new drainage at wound sites
Spinal or epidural blood clots (hematoma): People who take a blood thinner
medicine (anticoagulant) like XARELTO^®, 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
oA thin tube called an epidural catheter is placed in your back to give you
oYou take NSAIDs or a medicine to prevent blood from clotting
oYou have a history of difficult or repeated epidural or spinal punctures
oYou have a history of problems with your spine or have had surgery on your
If you take XARELTO^® 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 tingling, numbness, or muscle
weakness, especially in your legs and feet.
XARELTO^® is not for patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO^®?
Do not take XARELTO^® if you:
oCurrently have certain types of abnormal bleeding. Talk to your doctor
before taking XARELTO^® if you currently have unusual bleeding.
oAre allergic to rivaroxaban or any of the ingredients of XARELTO^®.
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO^®?
Before taking XARELTO^®, tell your doctor if you:
oHave ever had bleeding problems
oHave liver or kidney problems
oHave any other medical condition
oAre pregnant or plan to become pregnant. It is not known if XARELTO^® will
harm your unborn baby. Tell your doctor right away if you become pregnant
while taking XARELTO^®. If you take XARELTO^® during pregnancy, tell your
doctor right away if you have bleeding or symptoms of blood loss.
oAre breastfeeding or plan to breastfeed. It is not known if XARELTO^®
passes into your breast milk. You and your doctor should decide if you
will take XARELTO^® or breastfeed.
Tell all of your doctors and dentists that you are taking XARELTO^®. They
should talk to the doctor who prescribed XARELTO^® for you before you have any
surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal supplements. Some of your
other medicines may affect the way XARELTO^® works. Certain medicines may
increase your risk of bleeding. See "What is the most important information I
should know about XARELTO^®?"
Especially tell your doctor if you take:
oItraconazole (Onmel^™, Sporanox^®)
oCarbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol^®-XR, Teril^™,
oPhenytoin (Dilantin-125^®, Dilantin^®)
oRifampin (Rifater^®, Rifamate^®, Rimactane^®, Rifadin^®)
oSt. John's wort (Hypericum perforatum)
Ask your doctor if you are not sure if your medicine is one listed above. Know
the medicines you take. Keep a list of them to show your doctor and pharmacist
when you get a new medicine.
HOW SHOULD I TAKE XARELTO^®?
Take XARELTO^® exactly as prescribed by your doctor.
Do not change your dose or stop taking XARELTO^® unless your doctor tells you
oYour doctor will tell you how much XARELTO^® to take and when to take it.
oYour doctor may change your dose if needed.
If you take XARELTO^® for:
oAtrial Fibrillation: Take XARELTO^® 1 time a day with your evening
meal. If you miss a dose of XARELTO^®, take it as soon as you remember
on the same day. Take your next dose at your regularly scheduled
oBlood clots in the veins of your legs or lungs:
oTake XARELTO^® once or twice a day as prescribed by your doctor.
oTake XARELTO^® with food at the same time each day.
oIf you miss a dose of XARELTO^®:
oand take XARELTO^® 2 times a day: Take XARELTO^® as soon as
you remember on the same day. You may take 2 doses at the
same time to make up for the missed dose. Take your next dose
at your regularly scheduled time.
oand take XARELTO^® 1 time a day: Take XARELTO^® as soon as
you remember on the same day. Take your next dose at your
regularly scheduled time.
oHip or knee replacement surgery: Take XARELTO^® 1 time a day with or
without food. If you miss a dose of XARELTO^®, take it as soon as you
remember on the same day. Take your next dose at your regularly
oIf you have difficulty swallowing the tablet whole, talk to your doctor
about other ways to take XARELTO^®.
oYour doctor will decide how long you should take XARELTO^®. Do not stop
taking XARELTO^® without talking to your doctor first.
oYour doctor may stop XARELTO^® for a short time before any surgery,
medical or dental procedure. Your doctor will tell you when to start
taking XARELTO^® again after your surgery or procedure.
oDo not run out of XARELTO^®. Refill your prescription for XARELTO^® before
you run out. When leaving the hospital following a hip or knee
replacement, be sure that you have XARELTO^® available to avoid missing
oIf you take too much XARELTO^®, go to the nearest hospital emergency room
or call your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO^®?
Please see "What is the most important information I should know about
Tell your doctor if you have any side effect that bothers you or that does not
Call your doctor for medical advice about side effects. You are also
encouraged to report side effects to the FDA: visit
http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side
effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please seefull Prescribing Information, including Boxed Warnings,
About Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson,
Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the
major unmet medical needs of our time. Driven by our commitment to patients,
healthcare professionals, and caregivers, we strive to develop sustainable and
integrated healthcare solutions by working in partnership with all
stakeholders on the basis of trust and transparency. Our daily work is guided
by meeting goals of excellence in quality, innovation, safety, and efficacy in
order to advance patient care.
Our company provides medicines for an array of illnesses and disorders in
several therapeutic areas. Innovative therapies that Janssen Pharmaceuticals,
Inc. offers include ACIPHEX^® (rabeprazole sodium), ELMIRON^® (pentosan
polysulfate sodium), INVEGA^® SUSTENNA^® (paliperidone palmitate)
extended-release injectable suspension, INVOKANA^® (canagliflozin tablets),
NUCYNTA^® ER (tapentadol extended-release tablets), RISPERDAL^® CONSTA^®
(risperidone) Long-Acting Injection and XARELTO^® (rivaroxaban). The full
prescribing information for INVEGA^® SUSTENNA^®, NUCYNTA^® ER, RISPERDAL^®
CONSTA^® and XARELTO^®, including boxed warnings, are available here, here,
here, and here.
For more information on Janssen Pharmaceuticals, Inc., visit us at
www.janssenpharmaceuticalsinc.comor follow us on Twitter at
www.twitter.com/JanssenUSand on YouTube at www.Youtube.com/JanssenUS.
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Johnson & Johnson
Tel: (732) 524-6491
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SOURCE Janssen Pharmaceuticals, Inc.
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