A single 10 mg dose of rivaroxaban resulted in a 41% higher AUC in elderly compared with young subjects, but age alone and gender did not have a clinically relevant effect on pharmacokinetics or pharmacodynamics.
RCT (n=34)
single-blind
randomized
Does age or gender influence the pharmacokinetics and pharmacodynamics of a single 10 mg dose of rivaroxaban in healthy subjects?
Age and gender do not have a clinically relevant effect on the pharmacokinetics and pharmacodynamics of a single 10 mg dose of rivaroxaban in healthy subjects.
A randomized, single-blind, placebo-controlled, parallel-group study was conducted to assess the effect of age and gender on the pharmacokinetics and pharmacodynamics of rivaroxaban - an oral, direct Factor Xa inhibitor. Subjects (n = 34) were enrolled into four groups: young males or females (aged 18-45 years) and elderly males or females (aged >75 years), and received a single dose of 10 mg rivaroxaban. Pharmacokinetic and pharmacodynamic parameters were determined. Gender had no significant influence on the pharmacokinetics and pharmacodynamics of rivaroxaban. The area under the concentration-time curve (AUC) of rivaroxaban was 41% higher in elderly compared with young subjects; corresponding AUC values for the inhibition of Factor Xa activity and prolongation of prothrombin time were also higher. These changes were the result of reduced rivaroxaban clearance in elderly subjects, mainly owing to decreased renal function. The influence of age was not considered clinically relevant. The maximum plasma concentration was not increased in elderly subjects, and pharmacodynamic parameters returned close to baseline within 24 hours. The results indicate that age alone and gender did not have a clinically relevant effect on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy subjects after a 10 mg dose.
Kubitza et al. (2013) conducted an RCT in Healthy subjects (n=34). Rivaroxaban vs. Placebo was evaluated on Pharmacokinetics and pharmacodynamics. A single 10 mg dose of rivaroxaban resulted in a 41% higher AUC in elderly compared with young subjects, but age alone and gender did not have a clinically relevant effect on pharmacokinetics or pharmacodynamics.