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Efficacy and safety of atomoxetine hydrochloride in K orean adults with attention‐deficit hyperactivity disorder
Author(s) -
Lee Soyoung Irene,
Song DongHo,
Shin Dong Won,
Kim Ji Hoon,
Lee Young Sik,
Hwang JunWon,
Park Tae Won,
Yook KiHwan,
Lee Jong Il,
Bahn Geon Ho,
Hirata Yuko,
Goto Taro,
Takita Yasushi,
Takahashi Michihiro,
Lee Sanghoon,
Treuer Tamás
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/appy.12160
Subject(s) - atomoxetine , placebo , atomoxetine hydrochloride , attention deficit hyperactivity disorder , clinical global impression , adverse effect , psychology , rating scale , nausea , medicine , psychiatry , methylphenidate , developmental psychology , alternative medicine , pathology
This article aims to assess the efficacy and safety of atomoxetine in K orean 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 J apanese, K orean, and T aiwanese study sites focused on patient data from K orea (atomoxetine, n = 37; placebo, n = 37). Primary efficacy outcome was change in baseline‐to‐endpoint C onners' A dult ADHD R ating S cale‐ I nvestigator‐rated: S creening V ersion ( CAARS ‐ Inv:SV ) T otal ADHD S ymptoms score. Secondary efficacy outcomes included changes in A dult ADHD Q uality of L ife ( AAQoL ) total, B ehavior R ating I nventory of E xecutive F unction‐ A dult V ersion S elf‐ R eport ( BRIEF‐A : S elf‐ R eport), and C linical G lobal I mpression‐ ADHD ‐ S everity ( CGI‐ADHD‐S ) scale scores. Results Atomoxetine‐treated patients demonstrated a mean 18.9‐point reduction in CAARS‐Inv : SV total ADHD S ymptoms 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 : S elf‐ R eport 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 K orean patients. A high placebo response rate was observed in this adult K orean sample; a higher discontinuation rate was also observed in atomoxetine‐treated patients. These observations warrant further investigation.