Concomitant administration of rivaroxaban and aspirin did not alter the pharmacokinetics, pharmacodynamics, or safety of either drug in healthy male subjects.
RCT
2-way crossover
Does aspirin influence the safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban in healthy male subjects?
There is no clinically relevant pharmacokinetic or pharmacodynamic interaction between rivaroxaban and aspirin, suggesting they can be safely co-administered.
Rivaroxaban (BAY 59-7939) is an oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. This was a randomized, 2-way crossover study in healthy male subjects, with an aspirin run-in period, to examine whether aspirin influences the safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban. All treatments were well tolerated; drug-related adverse events were mild and transient. Aspirin did not alter the effects of rivaroxaban on Factor Xa activity or clotting tests. Platelet aggregation and bleeding time were not affected by rivaroxaban, and rivaroxaban did not influence the effects of aspirin on these parameters to a clinically relevant extent. Aspirin did not affect the pharmacokinetics of rivaroxaban, including the fraction unbound. This study suggests that there is no clinically relevant interaction between rivaroxaban and aspirin and that the 2 drugs could be administered concomitantly at the doses used in this study.
Kubitza et al. (Fri,) conducted a rct in Healthy. Rivaroxaban vs. Aspirin was evaluated on Safety, tolerability, pharmacodynamics, and pharmacokinetics. Concomitant administration of rivaroxaban and aspirin did not alter the pharmacokinetics, pharmacodynamics, or safety of either drug in healthy male subjects.
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