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Meta-analysis of aggression or hostility events in randomized, controlled clinical trials of atomoxetine for ADHD.

Author(s): Polzer J, Bangs ME, Zhang S, Dellva MA, Tauscher-Wisniewski S, Acharya N, Watson SB, Allen AJ, Wilens TE

Affiliation(s): Lilly Research Laboratories, Indianapolis, Indiana 46285, USA. polzer@lilly.com

Publication date & source: 2007-03-01, Biol Psychiatry., 61(5):713-9. Epub 2006 Sep 25.

Publication type: Comparative Study; Controlled Clinical Trial; Meta-Analysis; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: We systematically examined potential aggression/hostility-related events in a meta-analysis of acute clinical trials of atomoxetine for attention-deficit/hyperactivity disorder (ADHD). METHODS: Pediatric patients from 14 trials of atomoxetine were subdivided into a placebo-controlled (atomoxetine n = 1308, placebo n = 806) or active comparator databases (atomoxetine n = 566, methylphenidate n = 472). A third database comprised adult patients from placebo-controlled studies (atomoxetine n = 541, placebo n = 405). A computerized search of adverse events and comments identified patients with potential aggression/hostility events. Mantel-Haenszel incidence differences (MHID) were calculated. RESULTS: In the placebo-controlled database, we observed 21 atomoxetine and 9 placebo patients with reported aggression/hostility events, MHID of .6% (95% confidence interval [CI]: -.4, 1.7). In the active comparator database, there were seven events in atomoxetine and four in methylphenidate patients, MHID = .2% (95% CI: -1.0,1.3). In the adult database, there were no events in 0 atomoxetine and one placebo patient, MHID = -.3% (95% CI: -.8, .2). CONCLUSIONS: Aggression/hostility-related events occurred in less than 2% of patients and were more frequent in pediatric patients treated with atomoxetine versus placebo (risk ratio of 1.33; not statistically significant). The risk of aggression/hostility events was similar in patients treated with atomoxetine or methylphenidate.

Page last updated: 2007-05-03

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