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Data from the real-world XAMOS study just published in the journal Thrombosis and Haemostasis reaffirms the benefits of oral, once-daily Xarelto® (rivaroxaban) in everyday clinical practice to prevent potentially deadly blood clots in adults following major orthopaedic surgery of the hip or knee. Outcomes from the 17,000-patient study show Xarelto provided a favourable benefit-risk profile with patients experiencing fewer thromboembolic events and comparable low major bleeds compared to conventional pharmacological thromboprophylaxis regimens (standard of care).
"The XAMOS study indicates that using rivaroxaban in 1,000 patients following major orthopaedic surgery of the hip or knee could result in a reduction of five symptomatic thromboembolic events with an increase of less than one major bleeding event compared with standard of care, and importantly without the inconvenience and discomfort of traditional injectable treatments," said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada and Chairman of the XAMOS Executive Steering Committee. "These findings confirm the robust Phase III RECORD trial results are reflected in routine clinical practice, giving physicians and patients confidence in using rivaroxaban to protect against dangerous blood clots."
XAMOS is the largest non-interventional, open-label cohort study with a novel oral anticoagulant that compared outcomes observed in everyday clinical practice in 17,413 orthopaedic patients following major orthopaedic surgery of the hip or knee in 37 countries who were receiving Xarelto 10mg once daily or standard of care (predominantly low molecular weight heparins (LMWHs) like enoxaparin). Results show that the incidence of symptomatic thromboembolic events was lower in patients receiving Xarelto compared with standard of care (0.9% vs. 1.4%, respectively). Furthermore, low and comparable rates of major bleeding were observed in both study groups (major bleeding RECORD definition: 0.4% vs. 0.3%, respectively).
"These real-world insights confirm the pivotal Phase III data that demonstrated Xarelto can overcome limitations associated with traditional therapies, providing a higher degree of patient and physician satisfaction in terms of treatment tolerability and convenience," said Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "On top of five years of experience, these results provide further reassurance of the clinical use of Xarelto."
Xarelto is approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant.
About the XAMOS Study
XAMOS (XArelto® in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee) was an international, non-interventional, open-label cohort study assessing rivaroxaban for thromboprophylaxis in patients after major orthopaedic surgery of the hip or knee. The study assessed the safety and effectiveness of oral rivaroxaban 10mg once-daily or conventional pharmacological thromboprophylaxis regimens (standard of care) in everyday clinical practice.
Adult patients (aged 18 or over) undergoing major surgery of the hip or knee from 252 centres across 37 countries were enrolled in the study. The attending physician determined the type, duration and dose of thromboprophylaxis. All adverse events, including symptomatic thromboembolic and bleeding events, were documented by the investigators. Serious adverse events were followed-up until a final outcome was available.
About the RECORD Programme
Record is the world's largest Phase III clinical trial programme assessing novel oral anticoagulation in people requiring hip or knee replacement. The pooled analysis of RECORD 1-4 trials, which evaluated rivaroxaban (10mg given as one tablet, once-daily) in the prevention of VTE following elective total knee or hip replacement surgery and involved more than 12,500 patients, demonstrated a statistically significant relative risk reduction of over 50% in those treated with rivaroxaban by comparison to injectable enoxaparin.
The pooled results confirm findings from the four individual RECORD studies, which demonstrated the superior efficacy of rivaroxaban in preventing total VTE in both head-to-head comparisons with enoxaparin, as well as when comparing extended-duration (5 weeks) treatment with rivaroxaban with short-duration (2 weeks) enoxaparin followed by placebo. In all four studies, rivaroxaban and enoxaparin showed similar good safety profiles.
About Venous Arterial Thromboembolism (VAT)
Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.
VAT is responsible for a number of serious and life threatening conditions:
VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated and NICE recommended new oral anticoagulant and is marketed under the brand name Xarelto®. Xarelto is approved for five indications across seven distinct areas of use, consistently protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel OAC:
Whilst licences may differ from country to country, Xarelto is approved in more than 120 countries across all indications.
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 very high priority for Bayer, and the company has developed a number of materials including a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
Article adapted by Medical News Today from original press release. Source:
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