PMID- 20040824
OWN - NLM
STAT- MEDLINE
DCOM- 20100810
LR  - 20220318
IS  - 1527-5418 (Electronic)
IS  - 0890-8567 (Linking)
VI  - 48
IP  - 2
DP  - 2009 Feb
TI  - Safety and tolerability of atomoxetine over 3 to 4 years in children and 
      adolescents with ADHD.
PG  - 176-85
LID - 10.1097/CHI.0b013e318193060e [doi]
AB  - 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.
FAU - Donnelly, Craig
AU  - Donnelly C
AD  - Department of Child & Adolescent Psychiatry, Dartmouth-Hitchcock Medical Center, 
      1 Rope Ferry Road, Hanover, NH 03755-1404, USA. Craig.L.Donnelly@Dartmouth.edu
FAU - Bangs, Mark
AU  - Bangs M
FAU - Trzepacz, Paula
AU  - Trzepacz P
FAU - Jin, Ling
AU  - Jin L
FAU - Zhang, Shuyu
AU  - Zhang S
FAU - Witte, Michael M
AU  - Witte MM
FAU - Ball, Susan G
AU  - Ball SG
FAU - Spencer, Thomas J
AU  - Spencer TJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 0 (Adrenergic Uptake Inhibitors)
RN  - 0 (Propylamines)
RN  - 57WVB6I2W0 (Atomoxetine Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Adrenergic Uptake Inhibitors/*administration & dosage/adverse effects
MH  - Aggression/drug effects
MH  - Atomoxetine Hydrochloride
MH  - Attention Deficit Disorder with Hyperactivity/drug therapy/*physiopathology
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Hostility
MH  - Humans
MH  - Male
MH  - Propylamines/*administration & dosage/adverse effects
MH  - Psychiatric Status Rating Scales
MH  - Treatment Outcome
MH  - Vital Signs/drug effects
EDAT- 2009/12/31 06:00
MHDA- 2010/08/11 06:00
CRDT- 2009/12/31 06:00
PHST- 2009/12/31 06:00 [entrez]
PHST- 2009/12/31 06:00 [pubmed]
PHST- 2010/08/11 06:00 [medline]
AID - S0890-8567(09)60011-3 [pii]
AID - 10.1097/CHI.0b013e318193060e [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):176-85. doi: 
      10.1097/CHI.0b013e318193060e.