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RARITAN, N.J., Aug. 25, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that results from the Phase 3b exploratory X-VeRT study, investigating the oral Factor Xa inhibitor XARELTO® (rivaroxaban) in patients with non-valvular atrial fibrillation (NVAF) undergoing cardioversion, will be presented in a Hot Line Session during the upcoming ESC Congress 2014 in Barcelona, Spain, from August 30 - September 3, 2014.
The X-VeRT study is the first prospective exploratory trial comparing the efficacy and safety of the Factor Xa inhibitor, XARELTO®, once-daily, to a dose-adjusted vitamin K antagonist treatment, such as warfarin, in NVAF patients undergoing elective cardioversion. Elective cardioversion is a common medical procedure that converts an abnormally fast heart rate to a normal rhythm using electricity or antiarrhythmic medications. In addition to X-VeRT, sub-analyses from ROCKET AF and ATLAS ACS 2-TIMI 51 will be presented that provide further insights into the clinical utility of XARELTO®, the most studied and widely prescribed Factor Xa inhibitor in the world today.
The X-VeRT study (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prEvention of caRdiovascular events in patients with non-valvular aTrial fibrillation scheduled for cardioversion) is part of the EXPLORER global cardiovascular research program for XARELTO®. EXPLORER is an integral component of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions. The global clinical development program for XARELTO®, including EXPLORER, encompasses 15 Phase 3 clinical trials, 10 of which are completed. By the time of its completion, more than 260,000 patients will have participated in the XARELTO® clinical development program, including completed and ongoing clinical trials, independent registries and non-interventional studies. More than 136,000 of those patients have been or will be part of controlled, randomized clinical trials.
XARELTO® Hot Line Session
Oral and Poster Presentations on XARELTO® in Arterial Blood Clot Management
Sub-analyses from ROCKET AF and ATLAS ACS 2-TIMI 51 studies providing further insights into the clinical utility of XARELTO® (rivaroxaban) across arterial thromboembolic conditions include the following:
- Higher risk of death and stroke in patients with persistent versus paroxysmal atrial fibrillation: results from the ROCKET AF trial
- Oral Session: Atrial Fibrillation: How to improve prognosis?
- Tuesday, September 2, 2014, 8:308:45 CEST, Vilnius Village 9
- Digoxin use in patients with atrial fibrillation is associated with adverse cardiac outcomes: results from the ROCKET AF trial
- Oral Session: Atrial Fibrillation: How to improve prognosis?
- Tuesday, September 2, 2014, 9:009:15 CEST, Vilnius Village 9
- Patients with native aortic stenosis represent a high-risk subgroup in non-valvular atrial fibrillation: results from ROCKET AF trial
- Oral Session: Risk assessment in atrial fibrillation: what really matters?
- Tuesday, September 2, 2014, 3:003:15 CEST, Vilnius Village 9
- Rivaroxaban in patients after an acute coronary syndrome with cardiac biomarker elevation: insights from the ATLAS ACS 2-TIMI 51 trial
- Poster Session 6: Thrombosis and anticoagulation II
- Tuesday, September 2, 2014, 8:3012:30 CEST, Poster Area Central Village
Also, the company will present results from the Phase 2a X-PLORER study on once-daily rivaroxaban compared to unfractionated heparin after elective percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD).
About XARELTO® (rivaroxaban):
- XARELTO® is the most studied and widely prescribed oral Factor Xa inhibitor in the world today.
- Nine million patients have received XARELTO® worldwide, and more than eight million prescriptions have been written for XARELTO® in the U.S.
- XARELTO® is broadly reimbursed with 96 percent of patients on Medicare Part D and 92 percent of commercial patients covered at the lowest branded co-pay.
- XARELTO® has a broad indication profile and is approved for six indications:
- To reduce the risk of strokes and blood clots in patients 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.
- To treat patients with deep vein thrombosis (DVT).
- To treat patients with pulmonary embolism (PE).
- To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used 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.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
- For 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 your blood.
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.
- XARELTO® 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:
- Aspirin or aspirin-containing products
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin®, Jantoven®)
- Any medicine that contains heparin
- Clopidogrel (Plavix®)
- Other 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:
- Unexpected bleeding or bleeding that lasts a long time, such as:
- Nosebleeds that happen often
- Unusual bleeding from gums
- Menstrual bleeding that is heavier than normal, or vaginal bleeding
- Bleeding that is severe or that you cannot control
- Red, pink, or brown urine
- Bright red or black stools (looks like tar)
- Cough up blood or blood clots
- Vomit blood or your vomit looks like "coffee grounds"
- Headaches, feeling dizzy or weak
- Pain, 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 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 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 back pain, tingling, numbness, muscle weakness, (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).
XARELTO® is not for patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:
- Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
- Are 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:
- Have ever had bleeding problems
- Have liver or kidney problems
- Have any other medical condition
- Are 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.
- Are 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:
- Ketoconazole (Nizoral®)
- Itraconazole (Onmel, Sporanox®)
- Ritonavir (Norvir®)
- Lopinavir/ritonavir (Kaletra®)
- Indinavir (Crixivan®)
- Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril, Epitol®)
- Phenytoin (Dilantin-125®, Dilantin®)
- Phenobarbital (Solfoton)
- Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
- St. 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 to.
- Your doctor will tell you how much XARELTO®to take and when to take it.
- Your doctor may change your dose if needed.
If you take XARELTO® for:
- Atrial 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 time.
- Blood clots in the veins of your legs or lungs:
- Take XARELTO® once or twice a day as prescribed by your doctor.
- Take XARELTO® with food at the same time each day.
- If you miss a dose of XARELTO®:
- and 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.
- and 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.
- Hip 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 scheduled time.
- If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.
- Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO®without talking to your doctor first.
- Your 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.
- Do 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 any doses.
- If 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 XARELTO®?"
Tell your doctor if you have any side effect that bothers you or that does not go away.
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/medwatchor call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
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