European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jan 2017
Adverse drug events in patients with advanced chronic conditions who have a prognosis of limited life expectancy at hospital admission.
Adverse drug events (ADEs) lead to adverse clinical outcomes such as hospitalization. There is little information about the characteristics of ADEs in patients with advanced chronic conditions and have a prognosis of limited life expectancy. This study aimed to evaluate (i) the prevalence of ADEs at the time of admission to hospital, (ii) the causality, severity, and preventability of the ADEs, and (iii) the clinical and pharmacological characteristics associated with the ADEs. ⋯ ADEs are common, largely preventable, and implicated in the hospitalization of patients who require palliative care.
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Eur. J. Clin. Pharmacol. · Dec 2016
Target attainment analysis and optimal sampling designs for population pharmacokinetic study on piperacillin/tazobactam in neonates and young infants.
Population pharmacokinetic (popPK) analyses for piperacillin/tazobactam in neonates and infants of less than 2 months of age have been performed by our group previously. The results indicate that a dose of 44.44/5.56 mg/kg piperacillin/tazobactam every 8 or 12 h may not be enough for controlling infection in this population. In order to determine the appropriate dosing regimen and to provide a rationale for the development of dosing guidelines suitable for this population, further popPK studies of piperacillin/tazobactam would need to be conducted. The aim of the present study was to determine the appropriate dosing regimen and optimal sampling schedules in neonates and infants of less than 2 months of age. ⋯ The dosing regimen and sampling schedules proposed in this study should be evaluated in future popPK studies of piperacillin/tazobactam in neonates and infants. To the best of our knowledge, this is the first study that combined optimal sampling design with Monte Carlo simulation for designing popPK studies of piperacillin/tazobactam.
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Eur. J. Clin. Pharmacol. · Dec 2016
Observational StudyRelationships between oxycodone pharmacokinetics, central symptoms, and serum interleukin-6 in cachectic cancer patients.
Elevated serum proinflammatory cytokines are associated with the reduction of cytochrome P450 enzyme (CYP) activity. This study aimed to evaluate the oxycodone pharmacokinetics, central symptoms, and serum proinflammatory cytokines based on cachexia stage in cancer patients. ⋯ Cancer cachexia raised the plasma exposure of oxycodone through the reduction of CYP3A metabolic pathway. The reduction of CYP3A in cachectic cancer patients was associated with an elevation of serum IL-6. Although cachectic cancer patients with higher serum IL-6 levels had the symptom of somnolence, the alterations in oxycodone pharmacokinetics were not related to the incidence of symptom.
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Eur. J. Clin. Pharmacol. · Oct 2016
Randomized Controlled TrialLevobupivacaine absorption pharmacokinetics with and without epinephrine during TAP block: analysis of doses based on the associated risk of local anaesthetic toxicity.
Cases of local anaesthetic systemic toxicity (LAST) periodically occur following transversus abdominal plane (TAP) blocks. The aim of this study was to characterize levobupivacaine absorption pharmacokinetics, with and without epinephrine, and estimate the risk of LAST, based on a previously reported toxic threshold. ⋯ Our results strongly support the addition of epinephrine to the local anaesthetic solution, especially when doses of levobupivacaine of >1.5 mg kg(-1) are required. Recommendations regarding the maximum allowable doses of local anaesthetics should consider population analysis to determine safer dosage ranges.
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Eur. J. Clin. Pharmacol. · Oct 2016
ReviewPrevention of selective outcome reporting: let us start from the beginning.
Healthcare professionals and patients could be negatively influenced in their judgments by articles and meta-analyses presenting selective outcome reporting. Clinical trials should be transparent from inception to the publication of results. To this end, trial prospective registration is an ethical and scientific requirement that have shown to be effective in preventing selective reporting of outcomes. However, even journals with a clear pre-registration policy publish trial results that were retrospectively registered. ⋯ Retrospective registration of trials may foster selective outcome reporting unless journal editors implement specific quality control processes aiming to prevent or minimize this type of bias. Prospective registration of trials-and protocol public disclosure if proven effective in future studies-prevents outcome reporting bias, a must to ensure clinicians and patients have access to reliable clinical trial results. Journal editors should enforce, rather than encourage, appropriate measures to ensure publication of trials free of outcome reporting bias.