1. A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naïve Patients with Non-Valvular Atrial Fibrillation
- Author
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Dania Bozzato, Daniela Basso, Roberto Padrini, Francesca Groppa, Stefania Moz, Michela Pelloso, Giovanni Nante, Andrea Padoan, Elisa Gnatta, Seena Padayattil Jose, Anna Chiara Frigo, Carlo Federico Zambon, Enrico Tiso, Mario Plebani, Gentian Denas, Vittorio Pengo, and Paola Fogar
- Subjects
Adult ,Male ,lcsh:Medicine ,Polymorphism, Single Nucleotide ,law.invention ,Randomized controlled trial ,Cytochrome P-450 Enzyme System ,law ,Vitamin K Epoxide Reductases ,Atrial Fibrillation ,medicine ,Humans ,Dosing ,cardiovascular diseases ,Cytochrome P450 Family 4 ,International Normalized Ratio ,lcsh:Science ,Stroke ,Aged ,Cytochrome P-450 CYP2C9 ,Aged, 80 and over ,Multidisciplinary ,business.industry ,lcsh:R ,Warfarin ,Anticoagulants ,Atrial fibrillation ,Middle Aged ,medicine.disease ,Treatment Outcome ,Pharmacogenetics ,Pharmacodynamics ,Anesthesia ,lcsh:Q ,Female ,VKORC1 ,Drug Monitoring ,business ,Algorithms ,medicine.drug ,Research Article - Abstract
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.
- Published
- 2015