European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jul 2003
Clinical TrialParacetamol and metabolite pharmacokinetics in infants.
Data concerning metabolism of paracetamol in infants are scant. Previous studies have examined urinary metabolite recovery rates after a single dose of paracetamol in either neonates (<6 weeks) or children (3-9 years). There are no studies investigating infants. ⋯ Glucuronide formation clearance increases with age in the infant age range but sulphate formation does not. Renal clearance of paracetamol and its metabolites increases with urine flow rate. This and other studies show that paracetamol metabolism to glucuronide appears to be similar in infants and children, but in adults is increased in comparison with children. Oxidative pathways were undetectable in this infant study and may explain, in part, the reduced incidence of hepatotoxicity in infants.
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Eur. J. Clin. Pharmacol. · Jun 2003
Comparative Study Clinical TrialSystematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed.
To document the effect of systematic evaluation of pain in neonates on prescription of intravenous analgesics in a level-III neonatal intensive care unit (NICU) as a marker of increased awareness of treating and preventing pain. ⋯ Systematic evaluation of pain increased awareness of treating and preventing pain in neonates, even after correction for clinical co-variables. This increase was not associated with an increase in potential side-effects (length of respiratory support, length of parenteral nutrition).
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Eur. J. Clin. Pharmacol. · May 2003
Randomized Controlled Trial Comparative Study Clinical TrialEffects of fluticasone plus salmeterol versus twice the dose of fluticasone in asthmatic patients.
Current guidelines advocate adding a long acting beta(2)-agonist (LABA) to an inhaled corticosteroid as an alternative to increasing the dose of the latter. Since it is unclear how this translates into effects on surrogate inflammatory markers, we evaluated the anti-inflammatory activity of fluticasone plus salmeterol in combination versus twice the dose of fluticasone alone. ⋯ Double the dose of FP alone relative to FP+SM conferred superior effects on surrogate inflammatory markers but not on lung function. Long-term studies are required to evaluate whether these improvements on surrogate inflammatory markers translate into commensurate reductions in airway remodelling and exacerbations.
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Eur. J. Clin. Pharmacol. · Mar 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialIntravenously administered digoxin in patients with acute atrial fibrillation: a population pharmacokinetic/pharmacodynamic analysis based on the Digitalis in Acute Atrial Fibrillation trial.
Atrial fibrillation is commonly treated with intravenously administered digoxin. The main objective of this study was to investigate the relationship between plasma concentration of digoxin and heart rate. ⋯ A PK/PD model for the relationship between the plasma concentration of digoxin, the estimated concentration at the effect site and the reduction in heart rate during atrial fibrillation could be defined using a population pharmacokinetic approach. Our data indicate that a more aggressive dosing regimen of digoxin may be more effective in terms of heart rate reduction.
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Eur. J. Clin. Pharmacol. · Nov 2002
Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
. The aim of this study was to evaluate the number and the characteristics of medicines approved for children in Europe by the European Agency for the Evaluation of Medicinal Products (EMEA) and whether the paediatric studies supporting the authorisation were in accordance with the Note for Guidance on the Clinical Investigation of Medicinal Products in children (CPMP/ICH/2711/99). We also considered any possible difference between the EMEA and the Food and Drug Administration (FDA) paediatric medicines evaluations. ⋯ . Under the EMEA centralised procedure, several active substances have been licensed for children. Consequently serious and life-threatening diseases as AIDS and diabetes are now treatable, in a legal framework overcoming the orphan status of the past years. Despite the reported encouraging results, the number of drugs devoted to children remain low and important ATC classes, as L-(oncology) or N-(neurology), are still 'orphans' of innovative medicines. At the same time few medicinal products are specifically studied in children. Consequently, more efforts have to be made to increase the number of drugs assessed and licensed for the paediatric population, and manufacturers should be required to supply data on the effects of new drugs in children when the products are expected to offer a benefit over existing therapies.