RARITAN, N.J., Aug. 22, 2016 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., today announced that 25 abstracts have been accepted for presentation by Janssen and its development partner, Bayer, at the ESC Congress 2016, taking place August 27-31 in Rome, Italy. New real-world evidence from the EXPLORER research program, including latest findings from the REVISIT-US study, will address how XARELTO® (rivaroxaban), a non-vitamin K antagonist oral anticoagulant (NOAC), is performing in routine clinical practice. Also, the companies will unveil the design of the GALILEO trial, which seeks to address blood clot prevention for patients following successful transcatheter aortic valve replacement (TAVR).
"As more real-world research on the NOAC class of medicines becomes available, we continue to see that the benefit-risk profile of XARELTO® remains favorable and consistent with clinical trials," said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. "Our significant presence and the robustness of data at this year's ESC Congress 2016 underscore our commitment to providing physicians with the latest evidence on how XARELTO® is performing in the real world."
A listing of the data presentations is below:
Abstract Type/Title | Presentation Information |
New Real-World Insights In Non-Valvular Atrial Fibrillation | |
Poster Presentation (P2576): Real-world evidence of stroke prevention in patients with non-valvular atrial fibrillation in the United States: the REVISIT-US study | Poster Session 3: Anticoagulation in |
Poster Presentation (P2597): | Poster Session 3: Anticoagulation in |
Poster Presentation (P2570): Real-world evidence of stroke prevention in patients with non-valvular atrial fibrillation | Poster Session 3: Anticoagulation in |
Poster Presentation (P2606): | Poster Session 3: Anticoagulation in |
Poster Presentation (P2508): | Poster Session 3: Stroke and More |
Oral Presentation (2067): | Are You Still Afraid about Bleeding Risk of Antithrombotic Therapy in Atrial |
Oral Presentation (2953): | Registries Atrial Fibrillation |
Rapid Fire Abstract - Oral Presentation (3071): | Clinical Features and Management of |
New Unmet Medical Need Research | |
Oral Presentation (5012): | The Future is in the Pipeline |
Registry Data | |
Oral Presentation (2950): | Registries Atrial Fibrillation |
Poster Presentation (P3479): | Poster Session 4: Miscellaneous in |
Poster Presentation (P3482): | Poster Session 4: Miscellaneous in |
Oral Presentation (2954): | Registries Atrial Fibrillation |
Moderated Poster Presentation (P4100): | Antithrombotic Therapy in Atrial |
Moderated Poster Presentation (P4971): | Antithrombotic Therapy in Atrial |
Additional Non-Valvular Atrial Fibrillation Research | |
Poster Presentation (P2602): | Poster Session 3: Anticoagulation in |
Poster Presentation (P2569): | Poster Session 3: Anticoagulation in |
Poster Presentation (P2574): | Poster Session 3: Anticoagulation in |
Poster Presentation (P2566): | Poster Session 3: Anticoagulation in |
Pulmonary Embolism and Deep Vein Thrombosis Research | |
Oral Presentation (2359): | Optimizing the Treatment of Pulmonary |
Poster Presentation (P3710): | Poster Session 4: Acute Pulmonary |
Poster Presentation (P3717): | Poster Session 4: Acute Pulmonary |
Poster Presentation (P3813): | Poster Session 4: Thrombosis and |
Moderated Poster Presentation (P4124): | Advances in Pulmonary Embolism |
Rapid Fire Abstract - Oral Presentation (5964): | Antithrombotics in Daily Clinical |
About EXPLORER
Unmatched by any oral anticoagulant in the NOAC class in its size, scope and ambition, our EXPLORER research program continues to generate important clinical evidence on the safety and efficacy performance of XARELTO® and its potential role in addressing additional critical medical needs. By the time of its completion, more than 275,000 patients will have participated in the XARELTO® EXPLORER clinical development program, which includes ongoing and completed studies, independent registries and non-interventional studies. The EXPLORER program includes six additional indication-seeking programs underway beyond the currently approved six indications in the U.S. It is a collaborative research effort with Bayer that includes:
- COMMANDER HF: Reduction of the risk of major adverse cardiac events (MACE) in patients with chronic heart failure and significant coronary artery disease;
- COMPASS: Prevention of major cardiovascular events (heart attack, stroke, cardiovascular death) in patients with coronary or peripheral artery disease;
- MARINER: Prevention of symptomatic venous thromboembolism (VTE) and VTE-related death in high-risk, medically ill patients;
- NAVIGATE ESUS: Secondary prevention of stroke in patients who have experienced an embolic stroke of undetermined source (ESUS);
- VOYAGER PAD: Reduction of the risk of MACE in patients with coronary or peripheral artery disease; and,
- GEMINI ACS 1 (phase 2): Long-term secondary prevention of additional cardiovascular events in patients with acute coronary syndrome (ACS).
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®)
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
- 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
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