Efficacy and safety of atomoxetine hydrochloride in Korean adults with attention-deficit hyperactivity disorder

• Published in: Asia-Pacific psychiatry Vol. 6; no. 4; pp. 386 - 396
• Main Authors: Lee, Soyoung Irene, Song, Dong-Ho, Shin, Dong Won, Kim, Ji Hoon, Lee, Young Sik, Hwang, Jun-Won, Park, Tae Won, Yook, Ki-Hwan, Lee, Jong Il, Bahn, Geon Ho, Hirata, Yuko, Goto, Taro, Takita, Yasushi, Takahashi, Michihiro, Lee, Sanghoon, Treuer, Tamás
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01.12.2014; Wiley Subscription Services, Inc
• Subjects: ADHD; Adrenergic Uptake Inhibitors - administration & dosage; Adrenergic Uptake Inhibitors - adverse effects; Adult; atomoxetine; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Hyperactivity Disorder; Children & youth; Dose-Response Relationship, Drug; Double-Blind Method; executive function; Female; Humans; Hyperactivity; Korea; Male; Patients; Propylamines - administration & dosage; Propylamines - adverse effects; Quality of Life; Republic of Korea; Treatment Outcome; Republic of Korea; ADHD; quality of life; atomoxetine; Korea; executive function
• ISSN: 1758-5864; 1758-5872
• DOI: 10.1111/appy.12160

Introduction This article aims to assess the efficacy and safety of atomoxetine in Korean adults with attention‐deficit hyperactivity disorder (ADHD). Methods This post hoc double‐blind, placebo‐controlled study of atomoxetine (40–120 mg/day) over 10 weeks in adults with ADHD at 45 Japanese, Korean, and Taiwanese study sites focused on patient data from Korea (atomoxetine, n = 37; placebo, n = 37). Primary efficacy outcome was change in baseline‐to‐endpoint Conners' Adult ADHD Rating Scale‐Investigator‐rated: Screening Version (CAARS‐Inv:SV) Total ADHD Symptoms score. Secondary efficacy outcomes included changes in Adult ADHD Quality of Life (AAQoL) total, Behavior Rating Inventory of Executive Function‐Adult Version Self‐Report (BRIEF‐A:Self‐Report), and Clinical Global Impression‐ADHD‐Severity (CGI‐ADHD‐S) scale scores. Results Atomoxetine‐treated patients demonstrated a mean 18.9‐point reduction in CAARS‐Inv:SV total ADHD Symptoms score, compared with the 7.45‐point reduction in placebo‐treated patients (P ≤ 0.01). Significantly greater improvement was found for atomoxetine versus placebo in CGI‐ADHD‐S (P ≤ 0.01), BRIEF‐A:Self‐Report global executive composite (P ≤ 0.05), and metacognition index (P ≤ 0.01) executive function scores. Nausea, decreased appetite, and dry mouth were reported with significantly greater frequency by atomoxetine‐treated patients, and only one placebo‐treated patient discontinued because of adverse event. A 2.1‐kg reduction in weight and a 7.5‐beat/minute increase in pulse rate were observed in atomoxetine‐treated patients. Discussion These data support a significant benefit of 80‐ to 120‐mg once daily atomoxetine versus placebo for treatment of ADHD in adult Korean patients. A high placebo response rate was observed in this adult Korean sample; a higher discontinuation rate was also observed in atomoxetine‐treated patients. These observations warrant further investigation.