Rivaroxaban met primary efficacy endpoints and demonstrated a comparable safety profile with similar incidences of bleeding compared to standard-of-care across ten Phase III/IV trials.
Does rivaroxaban provide comparable efficacy and safety to standard-of-care in patients with thromboembolic disease?
Rivaroxaban demonstrates consistent efficacy and a comparable safety profile to traditional anticoagulants across multiple Phase III/IV trials for thromboembolic disease.
Traditional anticoagulants such as heparin and vitamin K antagonists have been the mainstay of antithrombotic therapy for many years. However, these drugs have a number of well-recognized drawbacks: unfractionated heparin, low molecular weight heparins and fondaparinux are administered parenterally, and vitamin K antagonists require routine coagulation monitoring. Novel, single-target oral anticoagulants have been developed that do not need routine coagulation monitoring, including the direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban, and the direct thrombin inhibitor dabigatran. Rivaroxaban is the most advanced in its clinical development. Across all ten Phase III/IV trials, rivaroxaban met the primary efficacy end points and generally had similar incidences of bleeding, with a comparable safety profile to standard-of-care.
Sebastian Schellong (2013) conducted a review in Thromboembolic disease. Rivaroxaban vs. Standard-of-care was evaluated on Primary efficacy end points. Rivaroxaban met primary efficacy endpoints and demonstrated a comparable safety profile with similar incidences of bleeding compared to standard-of-care across ten Phase III/IV trials.