作者: K. Hjälmås , A-L. Hellström , K. Mogren , G. Läckgren , A. Stenberg
DOI: 10.1046/J.1464-410X.2001.00084.X
关键词:
摘要: Objective To determine the safety, efficacy and pharmacokinetics of tolterodine in children with an overactive bladder. Patients methods Thirty-three (20 boys 13 girls, aged 5–10 years) bladder symptoms urgency, frequency and/or urge incontinence were enrolled open, dose-escalation study. Patients treated oral 0.5 mg (n = 11), 1 mg (n = 10) or 2 mg (n = 12) twice daily for 14 days. The primary safety endpoint was change residual urinary volume, as determined by ultrasonography. In addition, voiding diary variables (frequency episodes) evaluated. Other endpoints included laboratory variables, electrocardiogram recordings reported adverse events. Results There no concerns terms volume any three dosage groups; values comparable baseline after 2 weeks treatment all dosages. Adverse events 20 patients (six on 0.5 mg, five 1 mg, nine 2 mg). Most not considered to be drug-related; possibly related events, 10 occurred those taking 2 mg. Headache most commonly event. No serious there general concerns. improvement groups treatment, although greatest Pharmacokinetic findings consistent dose linearity over range 0.5–2 mg. Conclusion results support use optimal treating 5–10 years bladder.