Long-term atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder.

Full 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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Author information

Author/s: Wilens, Timothy E (TE); Newcorn, Jeffrey H (JH); Kratochvil, Christopher J (CJ); Gao, Haitao (H); Thomason, Christine K (CK); Rogers, Ann K (AK); Feldman, Peter D (PD); Levine, Louise R (LR);

Affiliation: Massachusetts General Hospital, Department of Psychiatry, Boston, Massachusetts, USA. twilens(-atsign-)partners.org

Journal and publication information

Publication Type: Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't

Journal: The Journal of pediatrics (J Pediatr), published in United States. (Language: eng)

Reference: 2006-Jul; vol 149 (issue 1) : pp 112-9

Dates: Created 2006/07/24; Completed 2006/08/31; Revised 2007/11/15;

PMID: 16860138, status: MEDLINE (last retrieval date: 12/26/2008)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent
Adrenergic Uptake Inhibitors - therapeutic use
Attention Deficit Disorder with Hyperactivity - drug therapy
Clinical Trials as Topic
Databases as Topic
Dose-Response Relationship, Drug

Female
Humans
Male
Propylamines - therapeutic use
Psychiatric Status Rating Scales
Treatment Outcome

Associated Chemicals: Adrenergic Uptake Inhibitors (0) ; Propylamines (0) ; atomoxetine (83015-26-3)

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