典型文献
Population pharmacokinetic and pharmacodynamic analysis of rivaroxaban in Chinese patients with non-valvular atrial fibrillation
文献摘要：
Rivaroxaban,a direct factor Xa inhibitor,is widely used for stroke prevention in patients with non-valvular atrial fibrillation(NVAF).The aim of this study was to conduct a population pharmacokinetic-pharmacodynamic(PK-PD)analysis of rivaroxaban in Chinese patients with NVAF to assess ethnic differences and provide model-based precision dosing.A total of 256 rivaroxaban plasma concentrations and 244 prothrombin time(PT)measurements were obtained from 195 Chinese NVAF patients from a prospective clinical trial.The population PK-PD model was developed using nonlinear mixed effects modeling(NONMEM)software.The PK of rivaroxaban was adequately described using a one-compartment model with first-order adsorption and elimination.Estimated glomerular filtration rate(eGFR)was identified as a major covariate for apparent clearance.No single nucleotide polymorphism was identified as a significant covariate.PT exhibited a linear relationship with rivaroxaban concentration.Total bilirubin(TBIL)and eGFR were identified as significant covariates for baseline PT.According to the Monte Carlo simulation,15 mg for Chinese patients with eGFR≥50 mL/min and normal liver function yielded an exposure comparable to 20 mg for Caucasian patients.Patients with moderately impaired renal function may require a lower dose of rivaroxaban to avoid overexposure.Moreover,there was an approximate 26％increase in PT levels in patients with TBIL of 34 μmol/L and eGFR of 30 mL/min,which could increase the risk of major bleeding.The established population PK-PD model could inform individualized dosing for Chinese NVAF patients who are administered rivaroxaban.
文献关键词：
中图分类号：
作者姓名：
Xiao-qin Liu;Yu-fei Zhang;Hong-yan Ding;Ming-ming Yan;Zheng Jiao;Ming-kang Zhong;Chun-lai Ma
作者机构：
Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Neurology,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Pharmacy,Shanghai Chest Hospital,Shanghai Jiao Tong University,Shanghai 200030,China
文献出处：
引用格式：
[1]Xiao-qin Liu;Yu-fei Zhang;Hong-yan Ding;Ming-ming Yan;Zheng Jiao;Ming-kang Zhong;Chun-lai Ma-.Population pharmacokinetic and pharmacodynamic analysis of rivaroxaban in Chinese patients with non-valvular atrial fibrillation)[J].中国药理学报（英文版）,2022(10):2723-2734
A类：
B类：
Population,pharmacokinetic,pharmacodynamic,analysis,rivaroxaban,Chinese,patients,valvular,atrial,fibrillation,Rivaroxaban,direct,Xa,inhibitor,widely,used,stroke,prevention,NVAF,aim,this,study,was,conduct,population,PK,assess,ethnic,differences,provide,precision,dosing,total,plasma,concentrations,prothrombin,PT,measurements,were,obtained,from,prospective,clinical,developed,using,nonlinear,mixed,effects,modeling,NONMEM,software,adequately,described,one,compartment,first,order,adsorption,elimination,Estimated,glomerular,filtration,eGFR,identified,major,apparent,clearance,No,single,nucleotide,polymorphism,significant,exhibited,relationship,Total,bilirubin,TBIL,covariates,baseline,According,Monte,Carlo,simulation,normal,liver,function,yielded,comparable,Caucasian,Patients,moderately,impaired,renal,may,require,lower,dose,avoid,overexposure,Moreover,there,approximate,increase,levels,which,could,risk,bleeding,established,inform,individualized,who,administered
AB值：
0.539505
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