International, Large-Scale, Real-World Clinical Data Confirm the Safety Profile of Rivaroxaban

Abstract

Rivaroxaban is a direct factor Xa inhibitor and a non-vitamin K antagonist (VKA) novel oral anticoagulant (NOAC) approved for a number of indications. It has been approved since 2011 by both the United States Food and Drug Administration and the European Medicines Agency for use in patients with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke and systemic embolism. However, anticoagulant therapy (both VKAs and NOACs) has been associated with an increased risk of bleeding. Although the majority of bleeding events are minor from a clinical standpoint (e.g. ecchymoses), major bleeding events have also been reported. This warrants the need for robust and large-scale clinical and safety data to guide physicians in patient selection, risk stratification, and treatment choice. While NOACs have been subject to a number of randomised clinical trials, observational studies, and real-world registries, large-scale observational studies are still scarce. This article reviews the newly published data from the XANTUS and the United States Department of Defense post-marketing safety surveillance studies, two landmark real-world observational studies on rivaroxaban use and safety in NVAF patients, and puts them in perspective with regard to clinical trial data and other real-world data. Both sets of results were presented at the European Society of Cardiology Congress on 31st August, 2015. This data collection represents more than 45,000 patients from 22 countries.