Effects of open-label atomoxetine on African-American and Caucasian pediatric outpatients with attention-deficit/hyperactivity disorder

Ann Clin Psychiatry. Jan-Mar 2009;21(1):26-37.

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 >or=3.0% of African-Americans and Caucasians discontinuing treatment because of adverse events. A significantly higher proportion of Caucasians reported >or=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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic Uptake Inhibitors / adverse effects*
  • Adrenergic Uptake Inhibitors / therapeutic use*
  • African Americans / statistics & numerical data*
  • Ambulatory Care*
  • Atomoxetine Hydrochloride
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Child
  • Drug Tolerance
  • Fatigue / chemically induced
  • Female
  • Heart Rate / drug effects*
  • Humans
  • Hypertension / chemically induced*
  • Hypertension / epidemiology
  • Male
  • Patient Compliance / statistics & numerical data
  • Propylamines / adverse effects*
  • Propylamines / therapeutic use*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Vomiting / chemically induced
  • Whites / statistics & numerical data*

Substances

  • Adrenergic Uptake Inhibitors
  • Propylamines
  • Atomoxetine Hydrochloride