Bangs Mark E, Wietecha Linda A, Wang Shufang, Buchanan Andrew S, Kelsey Douglas K
Eli Lilly and Company , Indianapolis, India na.
J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
This meta-analysis examined suicide-related events in the acute phases of double-blind, placebo-controlled atomoxetine trials in pediatric and adult patients with attention-deficit/hyperactivity disorder (ADHD).
A total of 3883 pediatric and 3365 adult patients were included. Potential events were identified from the adverse events database using a text-string search. Mantel-Haenszel risk ratios (MHRR) were calculated for potential suicide-related events categorized according to United States Food and Drug Administration defined codes.
In this data set, no completed suicides were reported in the pediatric or adult populations. One pediatric (attempted suicide) (and no adult patient events) was categorized as suicidal behavior in the atomoxetine group. The frequency of combined suicidal behavior or ideation with atomoxetine treatment was 0.37% in pediatric patients (vs. 0.07% with placebo) and 0.11% in adults (vs. 0.12% with placebo) and the risk compared with placebo was not statistically significant (MHRR=1.57; p=0.42 and MHRR=0.96; p=0.96, respectively). In pediatric patients, suicidal ideation only was reported more frequently compared with placebo (MHRR=1.63; p=0.41).
Overall in this data set, no completed suicides and 1 pediatric patient suicidal behavior event were reported in atomoxetine-treated pediatric and adult patients. Suicidal ideation was uncommon among atomoxetine-treated pediatric and adult patients, although it was reported more frequently in atomoxetine-treated pediatric patients compared with placebo; the reporting rate difference was not statistically significant. The MHRR of suicidal ideation was consistent with a previous meta-analysis of similar design. There was no evidence of increased risk for suicidal behavior in atomoxetine-treated pediatric or adult patients.
http://www.clinicaltrials.gov . The data reported are from an analysis of 23 pediatric and 9 adult clinical trials completed between 1998 and 2011. Ten pediatric (Studies HFBD, HFBK, LYAC, LYAS, LYAT, LYAW, LYAX, LYBG, LYBI, and LYBP) and two adult trials (Studies LYAA and LYAO) were conducted before the requirement to post trials at initiation (ongoing as of July 1, 2005) and, therefore, do not have a registration number. The registration numbers for the 13 pediatric trials meeting this requirement are: NCT00191698 (LYBX), NCT00486122 (LYCC), NCT00386581 (LYCZ), NCT00485459 (S010), NCT00191542 (LY15), NCT00191295 (LYBC), NCT00191906 (LYCK), NCT00192023 (LYCY), NCT00191945 (LYDM), NCT00546910 (LYDV), NCT00406354 (LYDW), NCT00380692 (S017), and NCT00607919 (LYEB). For the seven adult trials, the registration numbers are: NCT00190931 (LYBV), NCT00190957 (LYBY), NCT00190736 (LYCU), NCT00190775 (LYCW), NCT00190879 (LYDQ), NCT00510276 (LYDZ), and NCT00962104 (LYEE).
本荟萃分析研究了在患有注意力缺陷多动障碍（ADHD）的儿童和成人患者中，双盲、安慰剂对照的托莫西汀试验急性期与自杀相关的事件。
共纳入3883名儿童患者和3365名成人患者。通过文本字符串搜索从不良事件数据库中识别潜在事件。根据美国食品药品监督管理局定义的代码，对潜在的自杀相关事件计算Mantel-Haenszel风险比（MHRR）。
在该数据集中，儿童或成人患者中均未报告有自杀身亡事件。托莫西汀组中有1名儿童（自杀未遂）（无成人患者事件）被归类为自杀行为。托莫西汀治疗的儿童患者中，自杀行为或意念合并出现的频率为0.37%（安慰剂组为0.07%）；成人患者中为0.11%（安慰剂组为0.12%），与安慰剂相比风险无统计学意义（MHRR = 1.57；p = 0.42和MHRR = 0.96；p = 0.96）。在儿童患者中，仅自杀意念的报告频率高于安慰剂组（MHRR = 1.63；p = 0.41）。
总体而言在此数据集中，接受托莫西汀治疗的儿童和成人患者中未报告有自杀身亡事件，仅有1例儿童患者出现自杀行为事件。在接受托莫西汀治疗的儿童和成人患者中，自杀意念并不常见，尽管与安慰剂相比，接受托莫西汀治疗的儿童患者中报告频率更高；报告率差异无统计学意义。自杀意念的MHRR与之前类似设计的荟萃分析结果一致。没有证据表明接受托莫西汀治疗的儿童或成人患者自杀行为风险增加。
http://www.clinicaltrials.gov 。报告的数据来自对1998年至2011年间完成的23项儿童临床试验和9项成人临床试验的分析。10项儿童试验（HFBD、HFBK、LYAC、LYAS、LYAT、LYAW、LYAX、LYBG、LYBI和LYBP研究）和2项成人试验（LYAA和LYAO研究）是在试验开始时要求发布试验信息之前进行的（截至2005年7月1日仍在进行），因此没有注册号。符合此要求的13项儿童试验的注册号为：NCT00191698（LYBX）、NCT00486122（LYCC）、NCT00386581（LYCZ）、NCT00485459（S010）、NCT00191542（LY15）、NCT00191295（LYBC）、NCT00191906（LYCK）、NCT00192023（LYCY）、NCT00191945（LYDM）、NCT00546910（LYDV）、NCT00406354（LYDW）、NCT00380692（S017）和NCT00607919（LYEB）。7项成人试验的注册号为：NCT00190931（LYBV）、NCT00190957（LYBY）、NCT00190736（LYCU）、NCT00190775（LYCW）、NCT00190879（LYDQ）、NCT00510276（LYDZ）和NCT00962104（LYEE）。
