Relationship between warfarin dosage and international normalized ratio: a dose–response analysis and evaluation based on multicenter data.

Purpose: The objectives of the study were to establish a dose–response model for warfarin based on the relationship between daily warfarin dose and international normalized ratio (INR) and to evaluate the stability and reliability of the established model using external data. Methods: Clinical data...

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Publicado en:European Journal of Clinical Pharmacology Vol. 75; no. 6; pp. 785 - 795
Autores principales: Xue, Ling, Zhang, Yuzhen, Xie, Cheng, Zhou, Ling, Liu, Linsheng, Zhang, Haiyan, Xu, Lianhong, Song, Hongtao, Lin, Meiqin, Qiu, Hanfan, Zhu, Junrong, Zhu, Yubing, Zou, Jianjun, Zhuang, Wenfang, Xuan, Binbin, Chen, Yanhong, Fan, Yingchao, Wu, Di, Shen, Zhenya, Miao, Liyan
Formato: equations & formulas research tables/charts Journal Article
Publicado: Springer Nature Jun2019
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jun2019
      vid: 75
      iid: 6
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      pub: Springer Nature
      place: New York, New York
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        136694095
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        10.1007/s00228-019-02655-8
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        atl: Relationship between warfarin dosage and international normalized ratio: a dose–response analysis and evaluation based on multicenter data.
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        au:
          Xue, Ling
          Zhang, Yuzhen
          Xie, Cheng
          Zhou, Ling
          Liu, Linsheng
          Zhang, Haiyan
          Xu, Lianhong
          Song, Hongtao
          Lin, Meiqin
          Qiu, Hanfan
          Zhu, Junrong
          Zhu, Yubing
          Zou, Jianjun
          Zhuang, Wenfang
          Xuan, Binbin
          Chen, Yanhong
          Fan, Yingchao
          Wu, Di
          Shen, Zhenya
          Miao, Liyan
        affil: Department of Clinical Pharmacology, the First Affiliated Hospital of Soochow University, Suzhou, China
      sug:
        subj:
          Warfarin Administration and Dosage
          International Normalized Ratio
          Dose-Response Relationship, Drug
          Pharmacogenetics
          Human
          Outpatients
          Multicenter Studies
          Genotype
          Reliability
          Stability
          Goodness of Fit Chi Square Test
          Nonparametric Statistics
          Multivariate Statistics
          Linear Regression
          Descriptive Statistics
          Amiodarone Administration and Dosage
          Models, Biological
          Fat Free Mass
      ab: Purpose: The objectives of the study were to establish a dose–response model for warfarin based on the relationship between daily warfarin dose and international normalized ratio (INR) and to evaluate the stability and reliability of the established model using external data. Methods: Clinical data were recorded from 676 outpatients with a steady-state warfarin dosage. Demographic characteristics, concomitant medications, daily dosage of warfarin, CYP2C9 and VKORC1 genotypes, and INR were recorded. Data analysis based on the Michaelis–Menten equation to describe the relationship between daily warfarin dose and INR was performed using NONMEM. The reliability and stability of the final model were evaluated using goodness-of-fit plots, resampling techniques with a nonparametric bootstrap, and external data. Results: The daily warfarin dose and INR were described by a more pharmacologically expressive model than multivariate linear regression (MLR) model. The population standard value of Km was 3.56 mg, and the Hill coefficient was 0.512, with individual variabilities of 53.1% and 55.9%, respectively. CYP2C9 *1/*3, VKORC1 AA, concomitant amiodarone, and nonheart valve replacement reduced the warfarin Km by 30.4%, 74.3%, 34.5%, and 39.4%, respectively. The Km value decreased with age and increased with fat free mass (FFM). INR prediction error (73.0%) of the external datasets was within ± 20%. Conclusion: A dose–response model of warfarin was established based on the relationship between daily warfarin dose and INR. Expected genotype effects on Km and demographic characteristics were confirmed. The model has the potential to be a powerful tool for individualized warfarin therapy for Chinese outpatients.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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