Cited by 64Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesDevelopmental and Educational Neuropsychology

Acute atomoxetine treatment of younger and older children with ADHD: A meta-analysis of tolerability and efficacy

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Kratochvil, Christopher J, Milton, Denái R, Vaughan, Brigette S, Greenhill, Laurence L·2008·Child and Adolescent Psychiatry and Mental Health

Abstract

BACKGROUND: Atomoxetine is FDA-approved as a treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years to adult. Among pediatric clinical trials of atomoxetine to date, six with a randomized, double-blind, placebo-controlled design were used in this meta-analysis. The purpose of this article is to describe and compare the treatment response and tolerability of atomoxetine between younger children (6-7 years) and older children (8-12 years) with ADHD, as reported in these six acute treatment trials. METHODS: Data from six clinical trials of 6-9 weeks duration were pooled, yielding 280 subjects, ages 6-7 years, and 860 subjects, ages 8-12 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-diagnosed ADHD. Efficacy was analyzed using the ADHD Rating Scale-IV (ADHD-RS), Conners' Parent Rating Scale-revised (CPRS-R:S), and the Clinical Global Impression of ADHD Severity (CGI-ADHD-S). RESULTS: Atomoxetine was superior to placebo in both age categories for mean (SD) change in ADHD-RS total, total T, and subscale scores; 3 CPRS-R:S subscales; and CGI-ADHD-S from baseline. Although there were no significant treatment differentials between the age groups for these efficacy measures, the age groups themselves, regardless of treatment, were significantly different for ADHD-RS total (younger: ATX = -14.2 [13.8], PBO = -4.6 [10.4]; older: ATX = -15.4 [13.2], PBO = -7.3 [12.0]; p = .001), total T (younger: ATX = -15.2 [14.8], PBO = -4.9 [11.2]; older: ATX = -16.4 [14.6], PBO = -7.9 [13.1]; p = .003), and subscale scores (Inattentive: younger: ATX = -7.2 [7.5], PBO = -2.4 [5.7]; older: ATX = -8.0 [7.4], PBO = -3.9 [6.7]; p = .043; Hyperactive/Impulsive: younger: ATX = -7.0 [7.2], PBO = -2.1 [5.4]; older: ATX = -7.3 [7.0], PBO = -3.4 [6.3]; p < .001), as well as the CGI-ADHD-S score (younger: ATX = -1.2 [1.3], PBO = -0.5 [0.9]; older: ATX = -1.4 [1.3], PBO = -0.7 [1.1]; p = .010). Although few subjects discontinued from either age group due to adverse events, a significant treatment-by-age-group interaction was observed for abdominal pain (younger: ATX = 19%, PBO = 6%; older: ATX = 15%, PBO = 13%; p = .044), vomiting (younger: ATX = 14%, PBO = 2%; older: ATX = 9%, PBO = 6%; p = .053), cough (younger: ATX = 10%, PBO = 6%; older: ATX = 3%, PBO = 9%; p = .007), and pyrexia (younger: ATX = 5%, PBO = 2%; older: ATX = 3%, PBO = 5%; p = .058). CONCLUSION: Atomoxetine is an effective and generally well-tolerated treatment of ADHD in both younger and older children as assessed by three recognized measures of symptoms in six controlled clinical trials. TRIAL REGISTRATION: Not Applicable.

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  1. Kaufman J Birmaher B Brent D Rao U Ryan N Kiddie-SADS-Present and Lifetime Version (K-SADS-PL), version 10 of October 1996 edn 1996 Pittsburgh, PA: University of Pittsburgh Press
  2. Kelsey D Sutton V Lewis DW Schuh K Sumner C Quintana H Morning-Versus Evening-Dosed Atomoxetine: Effects on Core ADHD Symptoms In Proceedings of the 158th Annual Meeting of the American Psychiatric Association: 21–26 May 2005; Atlanta

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Authors
Kratochvil, C. J., Milton, D. R., Vaughan, B. S., & Greenhill, L. L.
Affiliations
  • Nebraska Medical Center (US)
  • Eli Lilly (United States) (US)
  • University of Nebraska Medical Center (US)
  • New York State Psychiatric Institute (US)
Corresponding author
Kratochvil, Christopher J
Venue
Child and Adolescent Psychiatry and Mental Health
Published
2008-09-15
Volume
2
Issue
1
Pages
25-25
ISSN
1753-2000 (ISSN-L)
OpenAlex
W1970632441
Cited by
64
References
22
Citations by year
2026: 2 · 2025: 1 · 2024: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 7 · 2015: 2 · 2014: 3 · 2013: 3 · 2012: 9
FWCI
0.86
Type
journal article
Language
en
Open access
Locations
  • Child and Adolescent Psychiatry and Mental Health (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DigitalCommons@UNMC (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
Eli Lilly and Company
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
Keywords
atomoxetine, attention deficit hyperactivity disorder, children with ADHD, age differences in treatment response, acute treatment, tolerability, efficacy, younger children, older children, ADHD Rating Scale-IV, Conners' Parent Rating Scale, stimulant medication, placebo response, adverse events, treatment discontinuation, hyperactivity/impulsivity, inattention

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