Premium
Open‐label, dose‐titration tolerability study of atomoxetine hydrochloride in K orean, C hinese, and T aiwanese adults with attention‐deficit/hyperactivity disorder
Author(s) -
Takahashi Michihiro,
Goto Taro,
Takita Yasushi,
Chung SangKeun,
Wang Yufeng,
Gau Susan ShurFen
Publication year - 2014
Publication title -
asia‐pacific psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.654
H-Index - 21
eISSN - 1758-5872
pISSN - 1758-5864
DOI - 10.1111/j.1758-5872.2012.00204.x
Subject(s) - atomoxetine , tolerability , discontinuation , adverse effect , medicine , somnolence , attention deficit hyperactivity disorder , nausea , atomoxetine hydrochloride , pediatrics , methylphenidate , psychiatry
The primary objective of this study was to assess the overall safety and tolerability of atomoxetine in K orean, C hinese, and T aiwanese adults with attention‐deficit/hyperactivity disorder ( ADHD ). Methods A total of 44 patients aged ≥18 years who met the C onners' A dult ADHD D iagnostic Interview for DSM‐IV diagnostic criteria for ADHD were enrolled from C hina, Korea, and T aiwan. 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 C onners' A dult ADHD R ating S cale‐ I nvestigator R ated: S creening V ersion ( CAARS ‐ I nv: 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 ‐ I nv: SV total ADHD symptom score was −12.5 ( P < 0.001). A significant reduction in the CAARS ‐ I nv: SV subscales (inattentive, hyperactive/impulsive, and ADHD index score, P < 0.001) was observed. Discussion This is the first atomoxetine clinical trial in adult patients with ADHD in C hina, K orea, and T aiwan. Atomoxetine was well tolerated in doses of up to 120 mg/day with no unknown safety concerns.