NC Neuropsych

Journal of the American Academy of Child & Adolescent Psychiatry:Volume 47(2)February 2008pp 209-218
Meta-Analysis of Suicide-Related Behavior Events in Patients Treated With Atomoxetine
[NEW RESEARCH]
BANGS, MARK E.http://www.problemsinanes.com/pt/re/jaacap/abstract.00004583-200802000-00016.htm;jsessionid=JM2QhKxSJThQWnv6DvdrQh5hwshR3srBJnJM4GLyVkT7TkFt3z1L!-256325120!181195629!8091!-1 M.D.; TAUSCHER-WISNIEWSKI, SITRA M.D.; POLZER, JOHN D.V.M.; ZHANG, SHUYU M.S.; ACHARYA, NAYAN M.B.B.S.; DESAIAH, DURISALA Ph.D.; TRZEPACZ, PAULA T. M.D.; ALLEN, ALBERT J. M.D., Ph.D.

All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.

Accepted August 20, 2007, under the Editorship of Mina K. Dulcan, M.D.

These data were presented as a poster at the 52nd Annual Meeting of the American Academy of Child and Adolescent Psychiatry on October 20, 2005 in Toronto. This research was supported by Eli Lilly and Company, Indianapolis. The authors thank Yu Ning for statistical analysis support. The authors thank the investigators for their role in the conduct of the trials that contributed data for this article and the many patients who participated in these trials. Consent to publish was granted by all of the patients/families mentioned in this article.

Clinical trial registration information-URL: http://www.clinicaltrials.gov . The data reported are from an analysis of 14 pediatric atomoxetine clinical trials. All but one of these trials were completed between 1998 and 2003, before the requirement to post trials at initiation (ongoing as of July 1, 2005) and therefore do not have a registration number. One trial did meet this requirement and is registered: #NCT00190931.

Correspondence to Dr. Mark E. Bangs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285; e-mail: bangsme@lilly.com.

Disclosure: All of the authors are employees of and shareholders in Eli Lilly and Company.

ABSTRACT
Objective: The present work examined suicide-related events in acute, double-blind, and placebo- or active comparator-controlled trials with atomoxetine.

Method: Fourteen trials in pediatric patients were included. Potential events were identified in the adverse events database using a text-string search. Potential suicide-related events were categorized according to U.S. Food and Drug Administration-defined codes using blinded patient summaries. The meta-analyses used the Mantel-Haenszel incidence difference and Mantel-Haenszel risk ratio methods.

Results: No patient in atomoxetine attention-deficit/hyperactivity disorder (ADHD) trials committed suicide. The frequency of suicidal ideation was 0.37% (5/1357) in pediatric patients taking atomoxetine versus 0% (0/851) for the placebo group; Mantel-Haenszel incidence difference of 0.46 (95% confidence interval 0.09-0.83; p =.016) and Mantel-Haenszel risk ratio of 2.92 (95% confidence interval 0.63-13.57; p =.172). Frequencies of suicide-related events in pediatric patients with ADHD did not differ between methylphenidate and atomoxetine treatments (Mantel-Haenszel incidence difference of -0.12 (95% confidence interval -0.62 to 0.38; p =.649). The number needed to harm in pediatric patients for an additional suicide-related event is 227 compared to the number needed to treat of five to achieve remission of ADHD symptoms.

Conclusions: Although uncommon, suicidal ideation was significantly more frequent in pediatric ADHD patients treated with atomoxetine compared to those treated with placebo. Retrospective analysis has limitations in ascertaining intent.

Copyright 2008 © American Academy of Child and Adolescent Psychiatry

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Copyright © 2009, American Academy of Child and Adolescent Psychiatry. All rights reserved.
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