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

Abstract

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