ArticleResearch and practice in thrombosis and haemostasis2026
Population pharmacokinetic and pharmacodynamic analysis of rivaroxaban in real-world patients with pulmonary embolism in China.
Article in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objectives: This study aimed to perform a population pharmacokinetic and pharmacodynamic analysis for rivaroxaban in real-world patients with pulmonary embolism for personalized medication. Methods: A prospective cohort study was conducted, and 187 eligible patients were included in this study. The analyses were executed using nonlinear mixed-effects modeling, and Monte Carlo simulations were used to obtain individualized dose adjustment strategies. Results: A total of 517 rivaroxaban plasma concentrations and 376 prothrombin time assays were used for model development. The pharmacokinetic parameters were adequately described using an oral 1-compartment model with first-order adsorption and elimination. The pharmacodynamic model revealed a linear relationship between rivaroxaban plasma concentrations and prothrombin time. The estimated typical values of Ka, V/F, and CL/F were 1.25/h, 53.0 L, and 6.13 L/h, respectively. The creatinine clearance and age were identified as covariates for the rivaroxaban pharmacokinetic profiles. Simulation results showed that patients with moderate renal impairment exhibited an ∼30% increase in rivaroxaban exposure, and that a low dose of 15 mg every day made their exposure similar to that of patients with normal renal function at 20 mg every day. Conclusion: The developed population pharmacokinetic and pharmacodynamic model can provide individualized dosing strategies for Chinese patients with pulmonary embolism. A lower dose is recommended for patients with moderate renal impairment to avoid overexposure and bleeding events.
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