Long-term atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder
Abstract
Objective To determine the efficacy and safety of atomoxetine in adolescent subjects treated for attention-deficit/hyperactivity disorder (ADHD) for up to 2 years.Study design Data from 13 atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects age 12 to 18 with ADHD as defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders IV.Results Of the 601 atomoxetine-treated subjects in this meta-analysis, 537 (89.4%) completed 3 months of acute treatment. A total of 259 subjects (48.4%) are continuing atomoxetine treatment; 219 of these subjects have completed at least 2 years of treatment. The mean dose of atomoxetine at endpoint was 1.41 mg/kg/day. Mean ADHD Rating Scale IV, parent version, investigator-administered and -scored total scores showed significant improvement (P < .001) over the first 3 months. Symptoms remained improved up to 24 months without dosage escalation. During the 2-year treatment period, 99 (16.5%) subjects discontinued treatment due to lack of effectiveness, and 31 (5.2%) subjects discontinued treatment due to adverse events. No clinically significant abnormalities in height, weight, blood pressure, pulse, mean laboratory values, or electrocardiography parameters were found.Conclusions Two-year data from this ongoing study indicate that atomoxetine maintains efficacy among adolescents with ADHD, with no evidence of drug tolerance and no new or unexpected safety concerns.
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Estimates of the time required for ATX to reach its maximum effect generally range from 4 to 6 weeks, although one study suggests that it may take as long as 12 weeks.
“In contrast, estimates of the time required for ATX to reach its maximum effect generally range from 4 to 6 weeks [3, 4], although, one study suggests that it may take as long as 12 weeks [36].”
Certain elements of the study design (the 9-week duration and once-daily dosing regimen) may not have elicited the maximum potential treatment benefit of ATX.
“Also, as noted earlier, certain elements of the study design (the 9-week duration and once-daily dosing regimen) may not have elicited the maximum potential treatment benefit of ATX [36, 38].”
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BackgroundMethodResultInfluentialHepatic Events Associated with Atomoxetine Treatment for??Attention-Deficit??Hyperactivity Disorder
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“Atomoxetine has been demonstrated to be of clear benefit in the adolescent population also.(65,66) In light of the potential benefit of treating adolescents who have ADHD, and the potential for negative sequelae without intervention, it is important to partner with the teens in their treatment planning.”
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“Atomoxetine is a well-tolerated, nonstimulant medication that has proven efficacy in reducing core ADHD symptoms in children and adolescents (Kratochvil et al., 2006; Wilens et al., 2006).”
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“Furthermore, it is the largest single study focusing on adolescent ADHD patients treated with atomoxetine (Wilens et al. 2006a, b) for which preliminary results on efficacy and tolerability have been published elsewhere (Dittmann et al. 2006; Dittmann et al. 2009; Wehmeier et al. 2008).”
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“Although estimates of the time required for atomoxetine to reach its maximum effect generally range from 4 to 6 weeks [8, 19], one study suggests that it may take as long as 12 weeks [20].”
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“Since approval, atomoxetine has demonstrated short- and long-term efficacy in children and adolescents [5, 9, 13, 16, 17 ], however, there has been limited study of atomoxetine’s effectiveness and tolerability in children selected according to a history of stimulant exposure (Quintana et al. [14]).”
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“The dose schedule for ATMX will be based on recommendations from clinical practice and previous literature (Figure 2) [18,33].”
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“652 Psychiatry Investig 2018;15(6):649-654 Effect of Atomoxetine on Growth in ADHD Youth”
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“whereas ATX is known to take at least 4 -- 6 weeks to reach its maximum effect [6].”
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- Authors
- Wilens, T. E., Newcorn, J. H., Kratochvil, C. J., Gao, H., Thomason, C. K., Rogers, A. K., Feldman, P. D., & Levine, L. R.
- Affiliations
- Mount Sinai Hospital (US)
- Corresponding author
- Wilens, Timothy E.
- Venue
- The Journal of Pediatrics
- Publisher
- Elsevier BV
- Published
- 2006-07
- Volume
- 149
- Issue
- 1
- Pages
- 112-119
- ISSN
- 0022-3476 (ISSN-L)
- OpenAlex
- W2050880665
- Cited by
- 102
- References
- 40
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 1 · 2022: 5 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 4 · 2014: 9 · 2013: 6 · 2012: 6
- FWCI
- 1.94
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- atomoxetine, attention deficit hyperactivity disorder, adolescents, long-term treatment, treatment efficacy, drug safety, drug tolerance, ADHD Rating Scale-IV, adverse events, dose escalation
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Attention Deficit Disorder with Hyperactivity, Clinical Trials as Topic, Dose-Response Relationship, Drug, Female, Humans, Male, Propylamines, Psychiatric Status Rating Scales, Treatment Outcome, Adrenergic Uptake Inhibitors, Databases as Topic
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