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

Todd M. Durell, MD

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

Andres J. Pumariega, MD

Department of Psychiatry, The Reading Hospital and Medical Center, Reading, PA, USA

Eugenio M. Rothe, MD

Robert Stempel School of Public Health, Florida International University, Miami, FL, USA

Jorge M. Tamayo, MD, BMSS

Department of Psychiatry, CES University, Medellín, Colombia, Department of Psychiatry, University of Puerto Rico, San Juan, PR

David Baron, MSEd, DO

Professor and Chair, Department of Psychiatry, Temple University School of Medicine, Philadelphia, PA, USA

David Williams, MS

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

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.

KEYWORDS: attention-deficit/hyperactivity disorder, atomoxetine, African-American, Caucasian, race

ANNALS OF CLINICAL PSYCHIATRY 2009;21(1):26–37

CORRESPONDENCE: Todd M. Durell, MD, Eli Lilly and Company, Lilly Corporate Center DC4135, Indianapolis, IN 46285 USA. E-MAIL: durellto@lilly.com
Annals of Clinical Psychiatry ©2009 American Academy of Clinical Psychiatrists

 
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