PLoS ONE (Jan 2015)

A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naïve Patients with Non-Valvular Atrial Fibrillation.

  • Vittorio Pengo,
  • Carlo-Federico Zambon,
  • Paola Fogar,
  • Andrea Padoan,
  • Giovanni Nante,
  • Michela Pelloso,
  • Stefania Moz,
  • Anna Chiara Frigo,
  • Francesca Groppa,
  • Dania Bozzato,
  • Enrico Tiso,
  • Elisa Gnatta,
  • Gentian Denas,
  • Seena Padayattil Jose,
  • Roberto Padrini,
  • Daniela Basso,
  • Mario Plebani

DOI
https://doi.org/10.1371/journal.pone.0145318
Journal volume & issue
Vol. 10, no. 12
p. e0145318

Abstract

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UNLABELLED:Genotype-guided warfarin dosing have been proposed to improve patient’s management. This study is aimed to determine whether a CYP2C9- VKORC1- CYP4F2-based pharmacogenetic algorithm is superior to a standard, clinically adopted, pharmacodynamic method. Two-hundred naïve patients with non-valvular atrial fibrillation were randomized to trial arms and 180 completed the study. No significant differences were found in the number of out-of-range INRs (INR3.0) (p = 0.79) and in the mean percentage of time spent in the therapeutic range (TTR) after 19 days in the pharmacogenetic (51.9%) and in the control arm (53.2%, p = 0.71). The percentage of time spent at INR>4.0 was significantly lower in the pharmacogenetic (0.7%) than in the control arm (1.8%) (p = 0.02). Genotype-guided warfarin dosing is not superior in overall anticoagulation control when compared to accurate clinical standard of care. TRIAL REGISTRATION:ClinicalTrials.gov NCT01178034.