کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3927946 1253191 2007 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Long-Term Tolerability of Tolterodine Extended Release in Children 5–11 Years of Age: Results from a 12-Month, Open-Label Study
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی زنان، زایمان و بهداشت زنان
پیش نمایش صفحه اول مقاله
Long-Term Tolerability of Tolterodine Extended Release in Children 5–11 Years of Age: Results from a 12-Month, Open-Label Study
چکیده انگلیسی

ObjectiveTo evaluate the long-term tolerability of tolterodine extended release (ER) in children (aged 5–11 yr) with urgency urinary incontinence (UUI).MethodsThis was a multicenter, open-label extension of a 12-wk, double-blind, placebo-controlled study of tolterodine ER. Patients had UUI suggestive of detrusor overactivity (≥1 diurnal incontinence episode per 24 h for ≥5 of 7 d) and ≥6 voids per 24 h at baseline and had completed the 12-wk double-blind study. Patients received tolterodine ER (2 mg once daily) for 12 mo. The primary end points were the incidence and severity of adverse events (AEs) and the incidence and reasons for withdrawals. Visits were scheduled at 3, 6, 9, and 12 mo, and investigators were instructed to report all AEs. At 6 and 12 mo, vital signs were recorded and a physical examination was performed.ResultsA total of 318 patients were enrolled (double-blind tolterodine ER, n = 221; placebo, n = 97). The majority of patients were white (90%), mean ± SD age was 7.6 ± 1.5 yr, and 54% were boys. Forty-nine percent of patients reported ≥1 AE during the study, similar to that observed in the preceding 12-wk study (42%). The most frequent AEs were urinary tract infection (7%), nasopharyngitis (5%), headache (5%), and abdominal pain (4%); 111 (35%) patients withdrew. The most common reasons for withdrawal were lack of efficacy (12%), symptom improvement (8%), and withdrawn consent (6%). Ten patients (3%) withdrew because of AEs.ConclusionLong-term treatment with tolterodine ER was well tolerated in children with UUI.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Urology - Volume 52, Issue 5, November 2007, Pages 1511–1517
نویسندگان
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