Long‐term safety and tolerability of atomoxetine in J apanese adults with attention deficit hyperactivity disorder

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 ( AE s), primarily nausea (4.3%; 10/233). Overall, 93.6% (218/233) of participants experienced treatment‐emergent AE s ( TEAE s), 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 TEAE s (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 AE s 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.