Hirata Yuko, Goto Taro, Takita Yasushi, Trzepacz Paula T, Allen Albert J, Ichikawa Hironobu, Takahashi Michihiro
Eli Lilly Japan K.K., Lilly Research Laboratories, Kobe, Japan.
Asia Pac Psychiatry. 2014 Sep;6(3):292-301. doi: 10.1111/appy.12119. Epub 2013 Dec 25.
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).
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).
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).
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.
本研究的主要目的是评估盐酸托莫西汀在患有注意力缺陷多动障碍（ADHD）的日本成年人中的长期安全性/耐受性。
这项为期48周的开放标签扩展研究纳入了完成了为期10周的盐酸托莫西汀随机对照试验的ADHD患者。参与者最初接受40毫克/天的盐酸托莫西汀治疗，随后逐步滴定至最大剂量120毫克/天。主要结局是安全性/耐受性。次要结局包括ADHD症状（康纳斯成人ADHD评定量表-研究者评定：筛查版18项总分）、生活质量（成人注意力缺陷/多动障碍生活质量量表）和执行功能（执行功能行为评定量表-成人版：自评）。
在总体39.5%中断研究的参与者中，15.9%（37/233）的参与者因不良事件（AE）中断研究，主要是恶心（4.3%；10/233）。总体而言，93.6%（218/233）的参与者出现了治疗中出现的不良事件（TEAE），最常见的是恶心（56.2%；131/233）、鼻咽炎（25.3%；59/233）、口渴（19.3%；45/233）、头痛（17.2%；40/233）和食欲下降（16.3%；38/233）。大多数TEAE（70.8%；165/233）强度为轻度。总体而言，79.8%（186/233）的参与者经历了≥1次药物不良反应，主要是恶心（55.4%；129/233）。在开放标签扩展阶段，有5名参与者出现严重AE；均与治疗无关/可能无关。生命体征有统计学意义的升高，体重有统计学意义的下降，但均不被认为具有临床意义。从基线到终点，ADHD症状、生活质量和执行功能均有显著改善（P<0.05）。
尽管由于长期开放标签设计导致部分患者退出研究，但因AE导致的退出比例适中，表明盐酸托莫西汀在患有ADHD的日本成年人中具有可接受的长期安全性和耐受性。在整个研究过程中，ADHD症状得到改善且持续改善。
Zotero 插件