Effects of open-label atomoxetine on African-American and Caucasian pediatric outpatients with attention-deficit/hyperactivity disorder.
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.
Durell
Todd M
TM
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. durellto@lilly.com
Pumariega
Andres J
AJ
Rothe
Eugenio M
EM
Tamayo
Jorge M
JM
Baron
David
D
Williams
David
D
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D001741:Black or African American / Q000706:statistics & numerical data*; D000553:Ambulatory Care; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004361:Drug Tolerance; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D010349:Patient Compliance / Q000706:statistics & numerical data; D011437:Propylamines / Q000009:adverse effects* / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D044465:White People / Q000706:statistics & numerical data*
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride