Eli Lilly and Company Ltd, Lilly House, Priestley Road, Basingstoke RG24 9NL, United Kingdom.
Child Adolesc Psychiatry Ment Health. 2013 Jun 19;7:19. doi: 10.1186/1753-2000-7-19. eCollection 2013.
Attention Deficit Hyperactivity Disorder (ADHD) is becoming an increasingly commonly diagnosed and treated childhood illness. Untreated ADHD is recognised as an independent risk factor for suicide-related events and deliberate self-harm and is reported more commonly in these populations. With the treatment of ADHD it is thus crucial to understand further any associations between pharmacological treatments and suicide-related events. Specific data for suicide-related events with stimulants have not been publically reported. Suicidal tendencies are, however, a contraindication to the treatment of patients with methylphenidate. Clinicians and patients may be helped by a meta-analytic comparison of suicide-related events in comparative randomised double-blind atomoxetine and methylphenidate clinical trials.
Suicide-related events retrospectively mapped to the suicide-related event assessment instrument recommended by the FDA, the Columbia Classification Algorithm for Suicide Assessment (C-CASA), were evaluated in five double-blind placebo controlled comparative studies of atomoxetine and methylphenidate (n = 1024) of 6 to 9 weeks duration. The Mantel-Haenszel risk ratio and Mantel-Haenszel incidence differences have been calculated.
In total there were 5 suicide-related events, atomoxetine (ATX) 3/559 and methylphenidate (MPH) 2/465. There were no suicide attempts nor completed suicides. Meta-analysis finds no difference of a difference in risk between ATX and MPH with a Mantel-Haenszel risk ratio of 0.52 (95% CI; 0.06, 4.54).
In the only reported meta-analysis of comparative suicide-related events between atomoxetine and methylphenidate, no significant evidence of a difference in risk has been found. These data may be informative to clinicians and patients when developing clinical guidelines.
注意力缺陷多动障碍(ADHD)是一种越来越常见的儿童疾病,且其发病率正在不断增加。未经治疗的 ADHD 被认为是自杀相关事件和故意自残的独立风险因素,在这些人群中更为常见。因此,在治疗 ADHD 时,了解药物治疗与自杀相关事件之间的任何关联至关重要。尚未公开报告过与兴奋剂相关的自杀相关事件的具体数据。然而,自杀倾向是使用哌醋甲酯治疗患者的禁忌症。对于比较随机双盲托莫西汀和哌醋甲酯临床试验中的自杀相关事件进行荟萃分析,可能会对临床医生和患者有所帮助。
回顾性地将自杀相关事件映射到 FDA 推荐的自杀相关事件评估工具——哥伦比亚自杀评估分类算法(C-CASA),对 5 项为期 6-9 周的双盲安慰剂对照比较托莫西汀和哌醋甲酯的临床试验(n=1024)中的自杀相关事件进行评估。计算了 Mantel-Haenszel 风险比和 Mantel-Haenszel 发生率差异。
共有 5 例自杀相关事件,托莫西汀(ATX)3/559,哌醋甲酯(MPH)2/465。没有自杀企图或自杀完成。荟萃分析发现,ATX 和 MPH 之间的风险差异没有统计学意义,Mantel-Haenszel 风险比为 0.52(95%CI:0.06, 4.54)。
在唯一报告的托莫西汀和哌醋甲酯之间比较自杀相关事件的荟萃分析中,未发现风险存在差异的显著证据。这些数据在制定临床指南时可能对临床医生和患者提供信息。