Document Detail

Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD.
MedLine Citation:
PMID:  20040824     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the long-term safety and tolerability of atomoxetine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder treated for > or = 3 years. METHOD: Data from 13 double-blind, placebo-controlled trials and 3 open-label extension studies were pooled. Outcome measures were patient-reported treatment-emergent adverse events (AEs); discontinuations due to AEs, serious AEs, and changes in body weight, height, vital signs, electrocardiogram, and hepatic function tests. RESULTS: In total, 714 patients were treated with atomoxetine for > or = 3 years (mean follow-up 4.8 years [SD 1.1 years]), including a subset of 508 treated for > or = 4 years (mean follow-up 5.3 years [SD 0.8 years]). Most subjects were younger than 12 years at entry (73.8%), male (78.4%), and white (88.9%). The mean final daily dose of atomoxetine was 1.35 mg/kg (SD 0.37 mg/kg). No new or unexpected AEs were observed compared with acute-phase treatment. Less than 6% of patients exhibited aggressive/hostile behaviors, and less than 1.6% reported suicidal ideation/behavior. No clinically significant effects were seen on growth rate, vital signs, or electrocardiographic parameters, and < or = 2% of patients showed potentially clinically significant hepatic changes. CONCLUSION: Atomoxetine was safe and well tolerated for children and adolescents with > or = 3 and/or > or = 4 years of treatment.
Craig Donnelly; Mark Bangs; Paula Trzepacz; Ling Jin; Shuyu Zhang; Michael M Witte; Susan G Ball; Thomas J Spencer
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American Academy of Child and Adolescent Psychiatry     Volume:  48     ISSN:  1527-5418     ISO Abbreviation:  J Am Acad Child Adolesc Psychiatry     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-12-30     Completed Date:  2010-08-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8704565     Medline TA:  J Am Acad Child Adolesc Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  176-85     Citation Subset:  IM    
Department of Child & Adolescent Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Rope Ferry Road, Hanover, NH 03755-1404, USA.
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MeSH Terms
Adrenergic Uptake Inhibitors / administration & dosage*,  adverse effects
Aggression / drug effects
Attention Deficit Disorder with Hyperactivity / drug therapy,  physiopathology*
Child, Preschool
Double-Blind Method
Drug Administration Schedule
Drug Toxicity
Propylamines / administration & dosage*,  adverse effects
Psychiatric Status Rating Scales
Treatment Outcome
Vital Signs / drug effects
Reg. No./Substance:
0/Adrenergic Uptake Inhibitors; 0/Propylamines; 83015-26-3/atomoxetine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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