Clinical and genetic determinants of warfarin pharmacokinetics and pharmacodynamics during treatment initiation

PLoS One. 2011;6(11):e27808. doi: 10.1371/journal.pone.0027808. Epub 2011 Nov 16.

Abstract

Variable warfarin response during treatment initiation poses a significant challenge to providing optimal anticoagulation therapy. We investigated the determinants of initial warfarin response in a cohort of 167 patients. During the first nine days of treatment with pharmacogenetics-guided dosing, S-warfarin plasma levels and international normalized ratio were obtained to serve as inputs to a pharmacokinetic-pharmacodynamic (PK-PD) model. Individual PK (S-warfarin clearance) and PD (I(max)) parameter values were estimated. Regression analysis demonstrated that CYP2C9 genotype, kidney function, and gender were independent determinants of S-warfarin clearance. The values for I(max) were dependent on VKORC1 and CYP4F2 genotypes, vitamin K status (as measured by plasma concentrations of proteins induced by vitamin K absence, PIVKA-II) and weight. Importantly, indication for warfarin was a major independent determinant of I(max) during initiation, where PD sensitivity was greater in atrial fibrillation than venous thromboembolism. To demonstrate the utility of the global PK-PD model, we compared the predicted initial anticoagulation responses with previously established warfarin dosing algorithms. These insights and modeling approaches have application to personalized warfarin therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Anticoagulants / pharmacokinetics*
  • Anticoagulants / pharmacology*
  • Aryl Hydrocarbon Hydroxylases / genetics
  • Blood Coagulation / drug effects*
  • Cytochrome P-450 CYP2C9
  • Cytochrome P-450 Enzyme System / genetics
  • Cytochrome P450 Family 4
  • Dose-Response Relationship, Drug
  • Female
  • Gene Frequency
  • Genotype
  • Humans
  • Kidney Function Tests
  • Male
  • Middle Aged
  • Mixed Function Oxygenases / genetics
  • Prospective Studies
  • Tissue Distribution
  • Vitamin K / metabolism
  • Vitamin K Epoxide Reductases
  • Warfarin / pharmacokinetics*
  • Warfarin / pharmacology*
  • Young Adult

Substances

  • Anticoagulants
  • Vitamin K
  • Warfarin
  • Cytochrome P-450 Enzyme System
  • Mixed Function Oxygenases
  • CYP2C9 protein, human
  • Cytochrome P-450 CYP2C9
  • Aryl Hydrocarbon Hydroxylases
  • Cytochrome P450 Family 4
  • CYP4F2 protein, human
  • VKORC1 protein, human
  • Vitamin K Epoxide Reductases