Meta-analysis of aggression or hostility events in randomized, controlled clinical trials of atomoxetine for ADHD.
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.
Polzer
John
J
Lilly Research Laboratories, Indianapolis, Indiana 46285, USA. polzer@lilly.com
Bangs
Mark E
ME
Zhang
Shuyu
S
Dellva
Mary Anne
MA
Tauscher-Wisniewski
Sitra
S
Acharya
Nayan
N
Watson
Susan B
SB
Allen
Albert J
AJ
Wilens
Timothy E
TE
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000368:Aged; D000374:Aggression / Q000187:drug effects*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology*; D002648:Child; D019992:Databases as Topic / Q000706:statistics & numerical data; D004311:Double-Blind Method; D005260:Female; D006791:Hostility; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use; D008875:Middle Aged; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011437:Propylamines / Q000627:therapeutic use*
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride