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Genotype-guided dosing of coumarin derivatives: the European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design

Lookup NU author(s): Professor Farhad Kamali, Professor Ann Daly

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Abstract

The narrow therapeutic range and wide interpatient variability in dose requirement make anticoagulation response to coumarin derivatives unpredictable. As a result, patients require frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms in VKORC1 and CYP2C9 jointly account for about 40% of the interindividual variability in dose requirements. To date, several pharmacogenetic-guided dosing algorithms for coumarin derivatives, predominately for warfarin, have been developed. However, the potential benefit of these dosing algorithms in terms of their safety and clinical utility has not been adequately investigated in randomized settings. The European Pharmacogenetics of Anticoagulant Therapy (EU-PACT) trial will assess, in a single-blinded and randomized controlled trial with a follow-up period of 3 months, the safety and clinical utility of genotype-guided dosing in daily practice for the three main coumarin derivatives used in Europe. The primary outcome measure is the percentage time in the therapeutic range for international normalized ratio. This report describes the design and protocol for the trial.


Publication metadata

Author(s): van Schie RMF, Wadelius M, Kamali F, Daly AK, Manolopoulos VG, de Boer A, Barallon R, Verhoef TI, Kirchheiner J, Haschke-Becher E, Briz M, Rosendaal FR, Redekop WK, Pirmohamed M, Maitland-van eer Zee AH

Publication type: Article

Publication status: Published

Journal: Pharmacogenomics

Year: 2009

Volume: 10

Issue: 10

Pages: 1687-1695

ISSN (print): 1462-2416

ISSN (electronic): 1744-8042

Publisher: Future Medicine Ltd.

URL: http://dx.doi.org/10.2217/PGS.09.125

DOI: 10.2217/PGS.09.125


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