title: Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder.
abstract: BACKGROUND
  The primary objective of this study was to assess the overall safety and tolerability of atomoxetine in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  A total of 44 patients aged ≥18 years who met the Conners' Adult ADHD Diagnostic Interview for DSM-IV diagnostic criteria for ADHD were enrolled from China, Korea, and Taiwan. In this open-label, dose-escalation study, patients received atomoxetine orally once daily over a period of eight weeks, starting at 40 mg/day (one week) up to a maximum dosage of 120 mg/day. Tolerability was evaluated by rate of discontinuation due to adverse events. Safety was assessed by recording all adverse events, laboratory tests, vital signs, and electrocardiograms. ADHD symptoms were evaluated by the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) for efficacy assessment.
  
  
  RESULTS
  Thirty-four patients (77.3%) completed the study. Atomoxetine was well tolerated with a discontinuation rate of 2.3% (1/44) due to adverse events. The most commonly reported adverse events were nausea, dizziness, and somnolence. The mean change from baseline to endpoint in CAARS-Inv:SV total ADHD symptom score was -12.5 (P < 0.001). A significant reduction in the CAARS-Inv:SV subscales (inattentive, hyperactive/impulsive, and ADHD index score, P < 0.001) was observed.
  
  
  CONCLUSIONS
  This is the first atomoxetine clinical trial in adult patients with ADHD in China, Korea, and Taiwan. Atomoxetine was well tolerated in doses of up to 120 mg/day with no unknown safety concerns.
authors.affiliation: Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Kobe, Japan; Terauchi-Takahashi Psychiatric Clinic, Ashiya, Japan.
authors.forename: Michihiro
authors.initials: M
authors.lastname: Takahashi
authors.forename: Taro
authors.initials: T
authors.lastname: Goto
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takita
authors.forename: Sang-Keun
authors.initials: SK
authors.lastname: Chung
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Wang
authors.forename: Susan Shur-Fen
authors.initials: SS
authors.lastname: Gau
mesh_terms: D000284:Administration, Oral; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000208:ethnology; D002681:China / Q000208:ethnology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011437:Propylamines / Q000008:administration & dosage* / Q000009:adverse effects; D056910:Republic of Korea; D013624:Taiwan / Q000208:ethnology; D016896:Treatment Outcome
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride
keywords: Chinese; Korean; Taiwanese; adult; atomoxetine; attention-deficit/hyperactivity disorder