Pharmacogenomics
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Randomized Controlled Trial
Rescue morphine in mechanically ventilated newborns associated with combined OPRM1 and COMT genotype.
Determine whether SNPs of OPRM1 118A>G (asn(40)asp), COMT 472G>A (val(158)met) and ARRB2 8622C>T are associated with morphine rescue in newborns on mechanical ventilation. ⋯ Combined OPRM1 118A>G and COMT 472G>A genotype might serve as a predictor for the need of rescue morphine in premature and term newborns on mechanical ventilation.
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Randomized Controlled Trial Multicenter Study
Genotype-guided dosing of coumarin derivatives: the European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design.
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. ⋯ 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.