Effects of Open-Label Atomoxetine on African-American and Caucasian Pediatric Outpatients with Attention-Deficit/Hyperactivity Disorder

Abstract

Background

Data on the management of attention-deficit/hyperactivity disorder (ADHD) in African-American children and adolescents are limited.

Methods

This study sought to evaluate the tolerability, safety, and efficacy of atomoxetine hydrochloride in the management of ADHD in African-American children and adolescents by conducting a post hoc subgroup analysis of 2 multicenter, open-label studies.

Results

Atomoxetine was safe and well tolerated, with ≥3.0% of African-Americans and Caucasians discontinuing treatment because of adverse events. A significantly higher proportion of Caucasians reported ≥1 treatment-emergent adverse event, including vomiting (7.2% vs 1.2%; P = .037) and fatigue (6.1% vs 0%; P = .012). No serious safety concerns were observed. Changes from baseline in height, weight, and hemodynamic variables were modest and similar in both racial subgroups. African-Americans and Caucasians showed significant improvement from baseline to end point in the mean ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-P:I). Scores decreased by 20.1 in African-Americans and by 19.55 in Caucasians, without significant between-group differences. Patients in both racial groups experienced similar, significant improvements in ADHDRS-IV-P:I inattention and hyperactivity-impulsivity symptoms, Clinical Global Impression-ADHD-Severity, and Conners’ Parent Rating Scale-Revised: Short Form.

Conclusions

Atomoxetine exhibited similar tolerability, safety, and efficacy profiles in African-Americans and Caucasians with ADHD.