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ABSTRACT
Background: Observational studies involving atomoxetine hydrochloride in the treatment of attention-deficit/hyperactivity disorder (ADHD) complement randomized controlled trials by assessing treatment effects in a usual-care setting and including a more heterogeneous patient population.
Objective: To provide data on the effectiveness of atomoxetine in a naturalistic treatment setting according to both physician and parent ratings.
Design and methods: A prospective, observational (non-interventional), longitudinal, open-label study of patients (N = 627; mean age = 11 years) with ADHD (from 60 physicians’ offices in the United States and Puerto Rico) whose physicians had decided to prescribe atomoxetine either as initial treatment or after trying another ADHD treatment (e.g., stimulants, antidepressants). Patients with a baseline visit and one post-baseline visit for up to 1 year were eligible. Atomoxetine administration, dosing, and timing of follow-up visits were at each physician's discretion. Physicians evaluated the effectiveness of atomoxetine using a single-item rating scale: the Physician Global Impression: ADHD Severity (PGI-ADHD-S) scale.
Results: The average reported duration of treatment was 21.2 (range 0–89) weeks. Over this period, treatment significantly lowered ADHD severity compared with baseline, with a mean change of –0.91 (95% confidence interval: –1.00 to –0.82; p < 0.001) on the PGI-ADHD-S scale. Physician-rated improvement was more marked in patients with more severe ADHD at baseline ( p < 0.001). Most patients (59–69%) experienced consistent symptom control at all times of the day. ADHD severity was improved similarly in patients across comorbid conditions (e.g., anxiety, depression, learning disorders), chief complaints (e.g., school problems, emotional problems), and prior treatment with stimulants or other medications. By parent reports, 49% of patients had improved grades following atomoxetine therapy while 35% stayed the same, and improvement in behavior (according to parents’ ratings) occurred in 49% of patients following atomoxetine therapy, whereas 31% stayed the same.
Conclusion: Data captured in this study support the conclusion that atomoxetine was effective in reducing symptom severity, and improving progress toward treatment goals, in children and adolescents with ADHD treated in a naturalistic treatment setting. However, given the open-label, observational (non-interventional) design of this study, certain biases cannot be excluded.