Uses
Atomoxetine hydrochloride is used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention-deficit hyperactivity disorder (ADHD).
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Attention Deficit Hyperactivity Disorder
Atomoxetine hydrochloride is used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of ADHD (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction) in adults and children 6 years of age and older. Efficacy of the drug for this indication was established in short-term (6-9 weeks) controlled clinical studies in children and adolescents 6-18 years of age and also in 10-week controlled clinical studies in adults who met DSM-IV criteria for ADHD. Efficacy of atomoxetine in the treatment of ADHD also was established in one longer-term (12 months) controlled clinical study in children and adolescents 6-15 years of age.
In controlled clinical studies in children 7-13 years of age with ADHD, therapy with atomoxetine (mean final dosage of 1.6 mg/kg daily, administered in 2 divided doses in the morning and late afternoon for 9 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHD Rating Scale-IV-Parent Version (ADHDRS), Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S), and Conners Parent Rating Scale-Revised: Short Form (CPRS-R:S). In another controlled clinical study in children and adolescents 6-16 years of age with ADHD, therapy with atomoxetine (mean final dosage of 1.3 mg/kg once daily in the morning for 6 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHDRS, Conners Parent Rating Scale, and Conners Teacher Rating Scale.
In a randomized, placebo-controlled, dose-response study with atomoxetine (0.5, 1.2, or 1.8 mg/kg daily, administered in 2 divided doses in the morning and late afternoon for 8 weeks) in children and adolescents 8-18 years of age with ADHD, therapy with atomoxetine 1.2 or 1.8 mg/kg daily was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHDRS, and improving social and family functioning, as measured by the Child Health Questionnaire (CHQ). Patients receiving atomoxetine 0.5 mg/kg daily exhibited responses intermediate to those observed in patients receiving placebo or atomoxetine at higher dosages (1.2 or 1.8 mg/kg daily), but no differences in response were observed between patients receiving dosages of 1.2 versus 1.8 mg/kg daily.
In an open-label, multicenter study in boys 7-15 years of age and girls 7-9 years of age with ADHD, therapy with atomoxetine (up to 2 mg/kg daily, administered in 2 divided doses in the morning and late afternoon) or methylphenidate (up to 60 mg daily, administered once daily or in 2 or 3 divided doses) for 10 weeks produced similar results in the reduction of ADHD symptoms; however, double-blind clinical studies are needed to establish the comparative efficacy and tolerance of these therapies.
In a randomized, double-blind, placebo-controlled maintenance study, 604 children and adolescents 6-15 years of age with ADHD initially received open-label atomoxetine (1.2-1.8 mg/kg daily in 2 divided doses) for 10 weeks. Patients who responded to therapy during the open-label phase were randomized at week 12 to receive either atomoxetine (at the same dosage) or placebo for an additional 9 months. At study end point, relapse (defined as an increase in ADHDRS total score to 90% of baseline score and an increase of 2 or more points on the CGI-S scale) occurred in fewer patients receiving atomoxetine compared with those receiving placebo (22 versus 38%). When the more sensitive secondary definition of relapse (an increase in ADHDRS total score to 50% of baseline score and an increase of 2 or more points on the CGI-S scale) was used, the relapse rate also was substantially lower in atomoxetine-treated patients (28%) than in placebo-treated patients (48%). In addition, patients who continued receiving atomoxetine experienced a longer time to relapse and achieved superior psychosocial functioning compared to those receiving placebo.
In controlled clinical studies in adults with ADHD, therapy with atomoxetine (mean final dosage of 95 mg daily, administered in 2 equally divided doses in the morning and late afternoon/early evening for 10 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the Conners Adult ADHD Rating Scale (CAARS).