PMID- 24376099
OWN - NLM
STAT- MEDLINE
DCOM- 20150527
LR  - 20220316
IS  - 1758-5872 (Electronic)
IS  - 1758-5864 (Linking)
VI  - 6
IP  - 3
DP  - 2014 Sep
TI  - Long-term safety and tolerability of atomoxetine in Japanese adults with 
      attention deficit hyperactivity disorder.
PG  - 292-301
LID - 10.1111/appy.12119 [doi]
AB  - INTRODUCTION: The primary aim of this study was to evaluate the long-term 
      safety/tolerability of atomoxetine in Japanese adults with attention deficit 
      hyperactivity disorder (ADHD). METHODS: This 48-week, open-label extension study 
      involved participants with ADHD who completed a 10-week randomized controlled 
      trial of atomoxetine. Participants received atomoxetine 40 mg/day, followed by 
      step-wise titration to a maximum of 120 mg/day. The primary outcome was 
      safety/tolerability. Secondary outcomes were symptoms of ADHD (Conners' Adult 
      ADHD Rating Scales-Investigator Rated: Screening Version 18-item total score), 
      quality of life (Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 
      scale), and executive function (Behavior Rating Inventory of Executive 
      Function-Adult Version: Self-report). RESULTS: Of the 39.5% of participants 
      overall who discontinued the study, 15.9% (37/233) of participants discontinued 
      because of adverse events (AEs), primarily nausea (4.3%; 10/233). Overall, 93.6% 
      (218/233) of participants experienced treatment-emergent AEs (TEAEs), most 
      commonly nausea (56.2%; 131/233), nasopharyngitis (25.3%; 59/233), thirst (19.3%; 
      45/233), headache (17.2%; 40/233), and decreased appetite (16.3%; 38/233). Most 
      TEAEs (70.8%; 165/233) were mild in intensity. Overall, 79.8% (186/233) of 
      participants experienced >/=1 adverse drug reaction, primarily nausea (55.4%; 
      129/233). Five participants experienced serious AEs during the open-label 
      extension; none was related/possibly related to treatment. There were 
      statistically significant increases in vital signs and decreases in body weight 
      that were not considered clinically significant. Symptoms of ADHD, quality of 
      life, and executive function were significantly improved from baseline to 
      endpoint (P < 0.05). DISCUSSION: Despite discontinuations due to the long-term, 
      open-label design, AE related discontinuations were modest, suggesting that 
      atomoxetine has acceptable long-term safety and tolerability in Japanese adults 
      with ADHD. Symptoms of ADHD improved and remained improved throughout the study.
CI  - (c) 2013 Wiley Publishing Asia Pty Ltd.
FAU - Hirata, Yuko
AU  - Hirata Y
AD  - Eli Lilly Japan K.K., Lilly Research Laboratories, Kobe, Japan.
FAU - Goto, Taro
AU  - Goto T
FAU - Takita, Yasushi
AU  - Takita Y
FAU - Trzepacz, Paula T
AU  - Trzepacz PT
FAU - Allen, Albert J
AU  - Allen AJ
FAU - Ichikawa, Hironobu
AU  - Ichikawa H
FAU - Takahashi, Michihiro
AU  - Takahashi M
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131225
PL  - Australia
TA  - Asia Pac Psychiatry
JT  - Asia-Pacific psychiatry : official journal of the Pacific Rim College of 
      Psychiatrists
JID - 101506757
RN  - 0 (Adrenergic Uptake Inhibitors)
RN  - 0 (Propylamines)
RN  - 57WVB6I2W0 (Atomoxetine Hydrochloride)
SB  - IM
MH  - *Adrenergic Uptake Inhibitors/administration & dosage/adverse 
      effects/pharmacology
MH  - Adult
MH  - Atomoxetine Hydrochloride
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - *Propylamines/administration & dosage/adverse effects/pharmacology
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asian
OT  - adult
OT  - atomoxetine
OT  - attention-deficit/hyperactivity disorder
OT  - safety
EDAT- 2014/01/01 06:00
MHDA- 2015/05/28 06:00
CRDT- 2013/12/31 06:00
PHST- 2013/03/14 00:00 [received]
PHST- 2013/11/14 00:00 [accepted]
PHST- 2013/12/31 06:00 [entrez]
PHST- 2014/01/01 06:00 [pubmed]
PHST- 2015/05/28 06:00 [medline]
AID - 10.1111/appy.12119 [doi]
PST - ppublish
SO  - Asia Pac Psychiatry. 2014 Sep;6(3):292-301. doi: 10.1111/appy.12119. Epub 2013 
      Dec 25.