PMID- 24472252 OWN - NLM STAT- MEDLINE DCOM- 20150326 LR - 20220310 IS - 1527-5418 (Electronic) IS - 0890-8567 (Linking) VI - 53 IP - 2 DP - 2014 Feb TI - Efficacy and safety of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: results from a comprehensive meta-analysis and metaregression. PG - 174-87 LID - S0890-8567(13)00814-9 [pii] LID - 10.1016/j.jaac.2013.11.005 [doi] AB - OBJECTIVE: To comprehensively evaluate the efficacy and safety of atomoxetine (ATX) in pediatric attention-deficit/hyperactivity disorder (ADHD). METHOD: Meta-analysis of all double-blind randomized controlled trials (DBRCTs) evaluating the efficacy and tolerability of ATX for ADHD. Pooled, random-effects analyses were conducted, calculating standardized mean difference (SMD), yielding effect sizes (ES), relative risk (RR), and number-needed-to-treat/harm (NNT/NNH).Moderator/mediator analyses were also conducted, including metaregression. RESULTS: Across 25 DBRCTs (56 treatment arms, N = 3,928), ATX outperformed placebo regarding overall ADHD symptoms (ES = -0.64, 95% confidence interval [CI] = -0.56 to -0.71, p < 0.0001), hyperactivity/impulsivity (ES = -0.67, CI = -0.53 to -0.81, p < 0.0001), and inattention (ES = -0.59, CI = -0.51 to -0.67, p < 0.0001). Altogether, 44.4% versus 21.4% of patients improved by >/=40% (NNT = 4), whereas 39.9% versus 65.9% improved by <25% (NNT = 4). Oppositional defiant disorder symptoms (ES = -0.33) and quality-of-life-related outcomes (ES = -0.48 to -0.25) improved somewhat less. A higher percentage of treatment-naive patients moderated the efficacy of ATX for overall ADHD symptoms (p = 0.017). All-cause discontinuation with ATX was similar to that for placebo (p = 1.00), with lower discontinuation because of inefficacy (relative risk [RR] = 0.51, CI = 0.36-0.74, p < 0.0001, NNT = 34), but higher discontinuation because of adverse effects (AEs) (RR = 1.89, CI = 1.08-3.31, p = 0.03, NNH = 50) with ATX. At least 1 adverse effect (AE) (70.4% versus 56.1%, p < 0.01, NNH = 6) and >/=1 psychiatric AE (21.5% versus 7.4%, NNH = 7, p < 0.01) were more frequent with ATX, whereas serious AEs (1.5% versus 1.0%), aggression (7.5% versus 6.0%), and suicidal ideation (1.3% versus 0.9%) were not different from placebo. CONCLUSIONS: Short-term ATX treatment is safe and superior to placebo for overall ADHD symptoms and key secondary outcomes, with a medium ES. However, a relevant patient subgroup (40%) continues to have significant symptomatology, requiring additional clinical attention. CI - Copyright (c) 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved. FAU - Schwartz, Shimon AU - Schwartz S AD - Zucker Hillside Hospital, Psychiatry Research, North Shore-Long Island Jewish (LIJ) Health System, and Montefiore Medical Center. FAU - Correll, Christoph U AU - Correll CU AD - Zucker Hillside Hospital, Psychiatry Research, North Shore-Long Island Jewish Health System, Hofstra North Shore-LIJ School of Medicine, Albert Einstein College of Medicine, and the Feinstein Institute for Medical Research. Electronic address: ccorrell@lij.edu. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20131126 PL - United States TA - J Am Acad Child Adolesc Psychiatry JT - Journal of the American Academy of Child and Adolescent Psychiatry JID - 8704565 RN - 0 (Adrenergic Uptake Inhibitors) RN - 0 (Propylamines) RN - 57WVB6I2W0 (Atomoxetine Hydrochloride) SB - IM CIN - J Am Acad Child Adolesc Psychiatry. 2014 Feb;53(2):135-7. PMID: 24472248 CIN - Evid Based Ment Health. 2014 Nov;17(4):108. PMID: 25165169 MH - Adolescent MH - Adrenergic Uptake Inhibitors/administration & dosage/adverse effects/*pharmacology MH - Atomoxetine Hydrochloride MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Child MH - Humans MH - Propylamines/administration & dosage/adverse effects/*pharmacology MH - *Treatment Outcome OTO - NOTNLM OT - atomoxetine OT - attention-deficit/hyperactivity disorder (ADHD) OT - children OT - efficacy OT - safety EDAT- 2014/01/30 06:00 MHDA- 2015/03/27 06:00 CRDT- 2014/01/30 06:00 PHST- 2013/05/15 00:00 [received] PHST- 2013/09/17 00:00 [revised] PHST- 2013/11/21 00:00 [accepted] PHST- 2014/01/30 06:00 [entrez] PHST- 2014/01/30 06:00 [pubmed] PHST- 2015/03/27 06:00 [medline] AID - S0890-8567(13)00814-9 [pii] AID - 10.1016/j.jaac.2013.11.005 [doi] PST - ppublish SO - J Am Acad Child Adolesc Psychiatry. 2014 Feb;53(2):174-87. doi: 10.1016/j.jaac.2013.11.005. Epub 2013 Nov 26.