European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Feb 2016
Clinical TrialGenotype and co-medication dependent CYP2D6 metabolic activity: effects on serum concentrations of aripiprazole, haloperidol, risperidone, paliperidone and zuclopenthixol.
Therapeutic drug monitoring (TDM) of antipsychotics can aid in therapy optimization, explaining adverse effects or non-response. One reason for therapeutic failure or adverse effects is caused by genetic variations in the cytochrome P450 drug-metabolizing genes. The aim of this study was to evaluate the impact of CYP2D6 polymorphisms on steady-state serum concentrations of antipsychotics metabolized by CYP2D6, taking into account the co-medication with CYP2D6 inhibitors. ⋯ Even with a small number of patients per antipsychotic, the importance of CYP2D6 genotyping was still clearly stated. This study illustrates the high potential of combining TDM and CYP2D6 genotyping in clinical practice.
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Eur. J. Clin. Pharmacol. · Jan 2016
Multicenter StudyOff-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.
The use of medicines among newborns admitted to intensive care units is characterized by a high prevalence of off-label/unlicensed use and a wide variability in the absence of international guidelines. A prospective cross-sectional study was organized with the aim to analyse drug prescriptions among all 107 Italian level III neonatal intensive care units. ⋯ Our results confirm the high prevalence of off-label/unlicensed drug use in the neonatal population and underline a better adherence to indications based on clinical practice, suggesting the need to update information contained in the data sheets of medicines.
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Eur. J. Clin. Pharmacol. · Dec 2015
Randomized Controlled TrialDexmedetomidine pharmacokinetics in the obese.
This study aims to characterize the influence of body weight and composition on the pharmacokinetics of dexmedetomidine. ⋯ The use of theory-based allometry with predictions of fat free mass has been able to separate the influences of weight and body composition and indicates that size-normalized clearance of dexmedetomidine is impaired in patients who are obese.
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Eur. J. Clin. Pharmacol. · Dec 2015
Clinical Trial Controlled Clinical TrialThe effects of ketoconazole and rifampin on the single-dose pharmacokinetics of crizotinib in healthy subjects.
To investigate the potential effects of strong CYP3A inhibitor ketoconazole and strong CYP3A inducer rifampin on the pharmacokinetics of crizotinib in human. ⋯ These findings suggest that CYP3A plays an important role in the metabolism of both crizotinib and PF-06260182, with the extent of this role being greater for PF-06260182. There were no serious adverse events or deaths and no dose reductions or temporary or permanent discontinuations due to drug-related adverse events in either study.