Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies
| Autor: | Otto Stroosma, Johan Vande Walle, David T Bolong, Piet Hoebeke, Ellen Dahler, Frank Verheggen, Israel Franco, Brigitte Bosman, Leon N. Davies, Malgorzata Baka-Ostrowska, Robert Snijder, Donald Newgreen |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Constipation Urology 030232 urology & nephrology Renal function Muscarinic Antagonists 03 medical and health sciences 0302 clinical medicine 030225 pediatrics medicine Humans Prospective Studies Urinary Bladder Neurogenic Child Oxybutynin Adverse effect Neurogenic bladder dysfunction Solifenacin Urinary bladder Urinary Bladder Overactive business.industry Solifenacin Succinate medicine.disease Treatment Outcome Urinary Incontinence medicine.anatomical_structure Tolerability Pediatrics Perinatology and Child Health medicine.symptom business medicine.drug |
| Zdroj: | Journal of Pediatric Urology. 16:180.e1-180.e8 |
| ISSN: | 1477-5131 |
| DOI: | 10.1016/j.jpurol.2019.12.012 |
| Popis: | Introduction The standard recommended treatment for neurogenic detrusor overactivity (NDO) is clean intermittent catheterization combined with an antimuscarinic agent. However, the adverse systemic side-effects of oxybutynin, the most widely used agent, are of concern. Objective To evaluate the efficacy and safety of solifenacin in pediatric patients with NDO, aged 6 months -= 40-week treatment period. Primary efficacy endpoint was change from baseline in maximum cystometric capacity (MCC) after 24 weeks. Secondary endpoints included bladder compliance, bladder volume until first detrusor contraction (>15 cm H2O), number of overactive detrusor contractions (>15 cm H2O), maximum catheterized volume (MCV)/24 h, and incontinence episodes/24 h. Safety parameters were treatment-emergent adverse events (TEAEs), serious adverse events, laboratory variables, vital signs, electrocardiograms, and ocular accommodation and cognitive function assessments. Results After 24 weeks, MCC had significantly increased compared with baseline in patients aged 6 months |
| Databáze: | OpenAIRE |
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