European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jun 2011
Pharmacodynamic and pharmacokinetic drug interactions reported to VigiBase, the WHO global individual case safety report database.
Drug interactions resulting in adverse drug reactions (ADRs) represent a major health problem both for individuals and the community. Despite this, limited information is reported in the literature on the drug interaction categories responsible for causing ADRs. In the study reported here, we investigated the drug combinations most frequently co-reported as interacting in the WHO Global Individual Case Safety Report (ICSR) database, VigiBase, and categorised these according to the drug interaction mechanism. ⋯ Drug interactions reported in globally collected ADR reports cover both pharmacodynamic, specifically additive pharmacological effects, and pharmacokinetic mechanisms primarily accredited to the inhibition of hepatic cytochrome P450 enzymes. These ADR reports often concern serious threats to patients' safety and are particularly related to the use of high risk drugs such as warfarin and heparin.
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Assessing pain intensity in (preverbal) children is more difficult than in adults. Tools to measure pain are being used as primary endpoints [e.g., pain intensity, time to first (rescue) analgesia, total analgesic consumption, adverse effects, and long-term effects] in studies on the effects of analgesic drugs. Here, we review current and promising new endpoints used in pediatric pain assessment studies.
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A wide range of outcome measures or endpoints has been used in clinical trials to assess the effects of treatments in paediatric respiratory diseases. This can make it difficult to compare treatment outcomes from different trials and also to understand whether new treatments offer a real clinical benefit for patients. Clinical trials in respiratory diseases evaluate three types of endpoints: subjective, objective and health-related outcomes. ⋯ The most common endpoints which are used in paediatric trials in respiratory diseases are discussed. For practical purposes, diseases have been separated into acute (bronchiolitis, acute viral-wheeze, acute asthma and croup) and chronic (asthma and cystic fibrosis). Further development of endpoints will enable clinical trials in children with respiratory diseases with the main objective of improving prognosis and safety.
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Eur. J. Clin. Pharmacol. · May 2011
Multicenter Study Clinical TrialInfluences on the pharmacokinetics of oxycodone: a multicentre cross-sectional study in 439 adult cancer patients.
Oxycodone is widely used for the treatment of cancer pain, but little is known of its pharmacokinetics in cancer pain patients. The aim of this study was to explore the relationships between ordinary patient characteristics and serum concentrations of oxycodone and the ratios noroxycodone or oxymorphone/oxycodone in cancer patients. ⋯ Women had lower oxycodone serum concentrations than men. CYP3A4 inducers/inhibitors should be used with caution as these are predicted to have a significant impact on oxycodone pharmacokinetics. Other characteristics explained only minor parts of the variability of the outcomes.
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Eur. J. Clin. Pharmacol. · May 2011
Risk factors associated with DRESS syndrome produced by aromatic and non-aromatic antipiletic drugs.
DRESS (drug reaction with eosinophilia and systemic symptoms) is an idiosyncratic entity associated with the use of drugs. Its pathophysiology is not known, but is associated with immunological or genetic factors. The incidence is 0.4 cases per 1,000,000 general population. The syndrome usually develops at the beginning of treatment and is characterized by the presence of rash, fever, eosinophilia and systemic manifestations. The aim of our study was to describe the clinical manifestation and treatment of patients with DRESS associated with antiepileptic drugs (AEDs). ⋯ DRESS is a severe cutaneous reaction, with high morbidity and mortality, whose development seems to be associated with individual susceptibility, type of antiepileptic drug used (more common with aromatic drugs), titration rate and concomitant medications.