Genotype-guided dosing of coumarin derivatives: the European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design
作者： Rianne MF Van Schie , MIA Wadelius , Farhad Kamali , Ann K Daly , Vangelis G Manolopoulos
DOI: 10.2217/PGS.09.125
关键词: Randomized controlled trial 、 Dosing 、 Warfarin 、 Therapeutic index 、 Pharmacogenetics 、 Clinical pharmacology 、 Acenocoumarol 、 Pharmacology 、 Medicine 、 VKORC1 、 Intensive care medicine
摘要: 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 avert adverse effects maintain efficacy. Polymorphisms VKORC1 CYP2C9 jointly account for about 40% of the interindividual requirements. To date, several pharmacogenetic-guided dosing algorithms derivatives, predominately warfarin, have been developed. However, potential benefit these terms their safety clinical utility has not adequately investigated randomized settings. European Pharmacogenetics Anticoagulant Therapy (EU-PACT) trial will assess, single-blinded controlled with follow-up period 3 months, genotype-guided daily practice three main used Europe. primary outcome measure is percentage time international normalized ratio. This report describes design protocol trial.
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