title: Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.
abstract: OBJECTIVE
  To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs.
  
  
  METHODS
  This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January-October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8-1.8 mg kg(-1) day(-1); n = 164) or twice-daily methylphenidate (0.2-0.6 mg kg(-1) day(-1); n = 166) for approximately 8 weeks. Primary efficacy assessment was the comparison of response rates (> or =40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight.
  
  
  RESULTS
  Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = -11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (-1.2 kg vs. -0.4 kg; p <0.001).
  
  
  CONCLUSIONS
  This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.
authors.affiliation: Institute of Mental Health, Beijing Medical University, Beijing, China.
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Wang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Yasong
authors.initials: Y
authors.lastname: Du
authors.forename: Dong H
authors.initials: DH
authors.lastname: Song
authors.forename: Yee-Jin
authors.initials: YJ
authors.lastname: Shin
authors.forename: Soo C
authors.initials: SC
authors.lastname: Cho
authors.forename: Bung N
authors.initials: BN
authors.lastname: Kim
authors.forename: Dong H
authors.initials: DH
authors.lastname: Ahn
authors.forename: Maria E
authors.initials: ME
authors.lastname: Marquez-Caraveo
authors.forename: Haitao
authors.initials: H
authors.lastname: Gao
authors.forename: David W
authors.initials: DW
authors.lastname: Williams
authors.forename: Louise R
authors.initials: LR
authors.lastname: Levine
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000069445:Atomoxetine Hydrochloride; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D010552:Personality Assessment; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000697:Central Nervous System Stimulants; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride