Rivaroxaban (BAY 59-7939) – an oral direct Factor Xa inhibitor – has no clinically relevant interaction with naproxen

摘要

What is already known about this subject• Rivaroxaban is a novel anticoagulant with predictable, dose-proportional pharmacokinetics and pharmacodynamics in healthy subjects.• It is in clinical development for the prevention of thromboembolic disorders in patients undergoing major orthopaedic surgery.• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen, are widely used for pain relief and treatment of inflammation, particularly in patients who have undergone orthopaedic surgery. As it is likely that patients receiving rivaroxaban after orthopaedic surgery will also receive NSAIDs, this study was performed to determine whether there was any mechanistic interaction between rivaroxaban and naproxen.What this study adds• This study demonstrated that there was no mechanistic interaction between rivaroxaban and naproxen in healthy subjects.• This finding was used to design large-scale clinical trials of rivaroxaban, in which patients were also allowed to use NSAIDs.• These ongoing trials will provide definitive data regarding the interaction between rivaroxaban and NSAIDs.AimsRivaroxaban (BAY 59-7939) is in advanced clinical development for the prevention and treatment of thromboembolic disorders. Frequent co-medications in the patient populations likely to receive rivaroxaban include NSAIDs. This randomized, two-way crossover study, with a naproxen run-in period, was performed to determine whether naproxen influences the tolerability, pharmacodynamics and pharmacokinetics of rivaroxaban.