Latest Xarelto® (Rivaroxaban) Data to be Presented at AHA 2012
- Multiple sub-analyses to be presented from the important Phase III ROCKET AF Study in patients with non-valvular Atrial Fibrillation (AF) and heart failure or diabetes
- Additional Phase III ATLAS ACS 2-TIMI 51 data analyses on rivaroxaban in secondary ACS prevention also to be presented
Oct 26th, 2012 - Bayer HealthCare announced today that new data from the clinical development programme for its oral anticoagulant Xarelto (rivaroxaban) will be presented at the American Heart Association (AHA) Scientific Sessions 2012 in Los Angeles, CA, USA, November 3-7, 2012. These data will provide further insights into the clinical utility of rivaroxaban for patients at risk of dangerous blood clots across multiple venous and arterial thromboembolic (VAT) conditions.
Notable data analyses on Bayer’s rivaroxaban to be presented at AHA 2012 include*:
Rivaroxaban Oral and Poster Presentations on Stroke Prevention in AF
- Rivaroxaban is associated with a reduced risk of thromboembolic events and hemorrhagic stroke in patients with heart failure: Insights from ROCKET-AF
- Oral Presentation: AOS.405.01-Treatment of Arrhythmias: Pharmacological I; Presentation: 14365
- Monday, November 5, 2012; 10:00–10:15; Room 403a
- Outcomes following cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF Trial
- Oral Presentation: AOS.406.04F-Managing Risk in Ablation of Atrial Fibrillation; Presentation: 19281
- Wednesday, November 7, 2012; 11:15–11:30; Room 403b
- Rivaroxaban compared with warfarin in patients with atrial fibrillation and diabetes: A subgroup analysis of the ROCKET AF trial
- Poster Session: APS.210.01-Diabetes Mellitus and CVD: Modulators of Risk I; Poster Board: 2091 – Presentation: 15544
- Monday, November 5, 2012; 15:00–16:30; Kentia Hall, Core 2
- Plasma proteomics reveal greater upregulation of thrombomodulin in patients treated with rivaroxaban compared with warfarin
- Poster Session: APS.709.02a-Thrombosis: Risk Factors, Pharmacology and Diagnosis; Poster Board: 7109 – Presentation: 16503
- Wednesday, November 7, 2012; 09:30–11:00; Kentia Hall, Core 7
Full data from ROCKET AF were presented at the AHA Scientific Sessions meeting in 2010 and were published in the New England Journal of Medicine (NEJM) in September 2011. Xarelto has received marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF in more than 70 countries worldwide, including the EU, the U.S. and Japan.
- Abstracts will be available online on the AHA Scientific Sessions Website as of Friday, November 2
Rivaroxaban Oral and Poster Presentations on Secondary Prevention of ACS
- Evaluation of cardiac events in ATLAS ACS 2-TIMI 51
- Oral Presentation: AOS.716.01-Key Insights from Recent ACS Trials: Novel Therapeutics and Patient Outcomes; Presentation: 16014
- Monday, November 5, 2012; 15:45–16:00; Hall A-10
- Temporal relationship between major hemorrhagic events and mortality among patients with Recent Acute Coronary Syndrome: Insights from ATLAS ACS 2-TIMI 51
- Oral Presentation: AOS.601.02a-Pharmacology for ACS and PCI; Presentation: 9944
- Tuesday, November 6, 2012; 14:30–14:45; Hall A-2
- A net clinical outcome analysis comparing fatal or irreversible ischemic and bleeding events in ATLAS ACS 2-TIMI 51
- Poster Session: APS.725.01-PCI: Procedural Considerations, Risk Factors and Complications; Poster Board: 7086 – Presentation: 13152
- Sunday, November 4, 2012; 15:00–16:30; Kentia Hall, Core 7
Full data from ATLAS ACS 2-TIMI 51 were presented at the American Heart Association (AHA) Scientific Sessions meeting in 2011 and were simultaneously published in the New England Journal of Medicine (NEJM). Rivaroxaban has been submitted for marketing authorisation to reduce secondary cardiovascular events in patients with ACS in more than 40 countries, including Europe and the US.
About Xarelto (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto. To date, Xarelto has been approved for use in the following venous arterial thromboembolic (VAT) indications:
- The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 70 countries worldwide
- The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) in adults in more than 70 countries worldwide
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide
Since the first approval of Xarelto in 2008, more than two and a half million patients worldwide have received Xarelto in daily clinical practice.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
Responsible use of Xarelto is a high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practices.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees
(Dec 31, 2011) and is represented in more than 100 countries. Find more information at www.healthcare.bayer.com.
Astrid Kranz, Tel. +49 30 468-12057
Stephanie Prate, Tel. +49 30 468-196053
Find more information at www.bayerpharma.com.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
- Formation of a clot inside a blood vessel.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.