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Various sections of the manuscript reviewed by:
J.J. Graham, Department of Psychiatry, University of Dundee, Dundee, UK; D.E. Greydanus, Department of Pediatrics and Human Development, Michigan State University, Kalamazoo, Michigan, USA; F.F. Levy, School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.
Data Selection
Sources: Medical literature published in any language since 1980 on 'atomoxetine', identified using MEDUNE and EMBASE, supplemented by AdisBase (a proprietary database of Wolters Kluwer Health I Adis). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.
Search strategy: MEDUNE, EMBASE and AdisBase search terms were 'atomoxetine' and [('attention deficit hyperactivity disorder' or 'ADHD') and ('infants' or 'children' or 'adolescents')]. Searches were last updated 10 February 2009.
Selection: Studies in pediatric patients with attention-deficit hyperactivity disorder who received atomoxetine. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.
Index terms: Atomoxetine, attention-deficit hyperactivity disorder, ADHD, children, adolescents, pharmacoeconomlcs, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.
Summary
Abstract Atomoxetine (Strattera®) is a selective norepinephrine (noradrenaline) reuptake inhibitor that is not classified as a stimulant, and is indicated for use in patients with attention-deficit hyperactivity disorder (ADHD).
Atomoxetine is effective and generally well tolerated. It is significantly more effective than placebo and standard current therapy and does not differ significantly from or is noninferior to immediate-release methylphenidate; however, it is significantly less effective than the extended-release methylphenidate formulation OROS® methylphenidate (hereafter referred to as osmotically released methylphenidate) and extended-release mixed amfetamine salts.
Atomoxetine can be administered either as a single daily dose or split into two evenly divided doses, has a negligible risk of abuse or misuse, and is not a controlled substance in the US. Atomoxetine is particularly useful for patients at risk of substance abuse, as well as those who have co-morbid anxiety or tics, or who do not wish to take a controlled substance. Thus, atomoxetine is a useful option in the treatment of ADHD in children and adolescents.
Pharmacologic Properties The mechanism of action of atomoxetine is unclear, but is thought to be related to...