Continued commitment to safety: building on the existing rivaroxaban knowledge base

Data from post-authorization studies and registries are valuable in establishing the safety and effectiveness of therapies in real-life settings, particularly as physicians may have concerns about the robustness of safety data from randomized controlled trials (RCTs). Furthermore, in routine clinical practice, there may be a potential for increased adverse event reporting with new therapies, and their true safety profile may be difficult to elucidate. The non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) rivaroxaban is a direct factor Xa inhibitor, first approved for the prevention of venous thromboembolism (VTE) following elective hip or knee replacement surgery in 2008, and now licensed for use in five indications in Europe in the venous and arterial thromboembolic space. A number of Phase IV, non-interventional studies, and independent registries are completed or underway that aim to further evaluate safety outcomes with rivaroxaban in everyday clinical practice. These include XAMOS (XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of the hip or knee), XANTUS (XArelto on preveNtion of sTroke and non-central nervoUS system systemic emboilism in patients with non-valvular atrial fibrillation), and XALIA (XArelto for Long-term and Initial Anticoagulation in venous thromboembolism). Results to date—from XAMOS—show that rivaroxaban has an acceptable safety profile in real-life, with outcomes that are in line with the RECORD (REgulation of Coagulation in ORthopedic surgery to prevent Deep vein thrombosis and pulmonary embolism) clinical trial programme. International and national registries are also gathering information on rivaroxaban and other NOACs. Together, this breadth of studies illustrates an ongoing commitment to understanding real-life outcomes with NOACs.