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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

Journal of Pediatric Urology Feb 06, 2020

Franco I, Hoebeke P, Baka-Ostrowska M, et al. - The two open-label, baseline-controlled, phase 3 studies were conducted to assess the efficacy and safety of solifenacin in pediatric individuals with neurogenic detrusor overactivity (NDO), aged 6 months–< 5 years and 5–< 18 years. Individuals have treated with sequential doses of solifenacin oral suspension (pediatric equivalent doses 2.5–10 mg) for 12 weeks to ascertain each individual's optimal dose, followed by a fixed-dose ≥ 40-week treatment period. After 24 weeks, compared with baseline, MCC had significantly raised in individuals aged 6 months –< 5 years and 5–< 18 years. The solifenacin was found to be effective and well-tolerated in pediatric patients with NDO, aged 6 months–<18 years, implying that it is a viable alternative to oxybutynin, the current standard of care.
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