ArticleEuropean journal of clinical pharmacology2026
Population pharmacokinetics of rivaroxaban after transjugular intrahepatic portosystemic shunt.
Article in European journal of clinical pharmacology, 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
purposeRivaroxaban, a new direct oral anticoagulant (DOAC), has demonstrated better efficacy and safety than traditional anticoagulants. Individualized anticoagulation is crucial in patients with a transjugular intrahepatic portosystemic shunt (TIPS) and portal vein hypercoagulability to avoid stent thrombosis. As TIPS shunts portal blood directly into the systemic circulation and may substantially affect the first-pass extraction/distribution of direct oral anticoagulants, no population prospective pharmacokinetic studies have been published in patients undergoing TIPS placement so far. The goal of this study was to establish a PopPK model for rivaroxaban in post-TIPS patients, investigate clinical covariate effects on PK, and provide an optimized dosing regimen.
methodsIn this single-centre prospective study, 39 adult patients underwent TIPS and received rivaroxaban 5 or 10 mg once daily thereafter. Population PK analysis was conducted in NONMEM with 131 plasma concentrations available from 38 evaluable patients (median age: 56 years; median body weight: 63.8 kg). Parameterized model was then applied to simulate steady-state exposure of 5, 7.5, 10, and 15 mg once daily regimen.
resultsThe final PopPK model was based on a one-compartment with sequential zero-order followed by first-order absorption kinetics, and included the effects of an absorption lag time and linear elimination. The apparent clearance and volume of distribution were 7.48 L/h and 4.75 L, respectively. Based on patient-specific simulations of 38 subjects, at the 5 mg/day dose, an exposure within predefined limits was potentially preserved in 96.7% of the cases vs. 62.5% for the 10 mg/day (thresholds: AUCss,24 ≤ 1.77 mg·h/L and Cmax, ss ≤ 140 µg/L). This trend was confirmed by Monte-Carlo simulations in 1,000 virtual patients and suggests TDM when the higher dosage is given.
conclusionsThis PopPK model provides an initial characterisation of rivaroxaban disposition in post-TIPS patients and reveals a markedly reduced apparent V/F relative to non-TIPS populations. The 5 mg once-daily regimen is generally safe, while the 10 mg dose may be considered with therapeutic drug monitoring to account for substantial inter-individual pharmacokinetic variability in post-TIPS patients.
trial registrationChinese Clinical Trial Registry, ChiCTR (ChiCTR2300073784); registered 20 July 2023.
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