INTRODUCTION:Nocturnal enuresis is a condition in which children at least 5 years of age are incontinent of urine at night. Atomoxetine, a potent inhibitor of the presynaptic norepinephrine transporter, is used to treat attention-deficit/hyperactivity disorder (ADHD). This study tested the hypothesis that atomoxetine will provide significant therapeutic benefit for nocturnal enuresis in patients with the diagnosis of nocturnal enuresis. METHODS:Atomoxetine's efficacy for improving nocturnal enuresis was studied in 87 pediatric subjects using an outpatient, multicenter, randomized, double-blind, parallel, placebo-controlled study. Efficacy was determined by measuring the mean number of dry nights per week using an intent-to-treat analysis of the primary outcome measure, the Dry Night Log-Parent Report (DNL-PR), a daily parent diary. RESULTS: Baseline and end point DNL-PR data were available from 42 atomoxetine-treated and 41 placebo-treated subjects. Atomoxetine increased the average number of dry nights per week by 1.47 compared with .60 for placebo (F = 7.06; df = (1, 75); p = 0.01). Fifteen atomoxetine-treated subjects (35.7%) had an increase of at least 2 dry nights per week compared with only 6 (14.6%) placebo-treated subjects (Fisher's exact test; p = 0.042). There were no significant differences in adverse events between the groups. CONCLUSIONS: Compared with placebo, atomoxetine treatment was associated with a significant increase in dry nights in children with nocturnal enuresis.
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INTRODUCTION:Nocturnal enuresis is a condition in which children at least 5 years of age are incontinent of urine at night. Atomoxetine, a potent inhibitor of the presynaptic norepinephrine transporter, is used to treat attention-deficit/hyperactivity disorder (ADHD). This study tested the hypothesis that atomoxetine will provide significant therapeutic benefit for nocturnal enuresis in patients with the diagnosis of nocturnal enuresis. METHODS:Atomoxetine's efficacy for improving nocturnal enuresis was studied in 87 pediatric subjects using an outpatient, multicenter, randomized, double-blind, parallel, placebo-controlled study. Efficacy was determined by measuring the mean number of dry nights per week using an intent-to-treat analysis of the primary outcome measure, the Dry Night Log-Parent Report (DNL-PR), a daily parent diary. RESULTS: Baseline and end point DNL-PR data were available from 42 atomoxetine-treated and 41 placebo-treated subjects. Atomoxetine increased the average number of dry nights per week by 1.47 compared with .60 for placebo (F = 7.06; df = (1, 75); p = 0.01). Fifteen atomoxetine-treated subjects (35.7%) had an increase of at least 2 dry nights per week compared with only 6 (14.6%) placebo-treated subjects (Fisher's exact test; p = 0.042). There were no significant differences in adverse events between the groups. CONCLUSIONS: Compared with placebo, atomoxetine treatment was associated with a significant increase in dry nights in children with nocturnal enuresis.
Authors: Sharon L Walsh; Lisa S Middleton; Conrad J Wong; Paul A Nuzzo; Charles L Campbell; Craig R Rush; Michelle R Lofwall Journal: Drug Alcohol Depend Date: 2012-11-28 Impact factor: 4.492
Authors: Angelo Camporeale; Kathleen Ann Day; Dustin Ruff; Jody Arsenault; David Williams; Douglas K Kelsey Journal: Drug Saf Date: 2013-08 Impact factor: 5.606