2005, Number 5
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Bol Med Hosp Infant Mex 2005; 62 (5)
Efficacy and safety of atomoxetine for the treatment of the attention deficit disorder in a pediatric population.
Barragán-Pérez E, Borboa-Arce E, Garza-Morales S, Hernández-Aguilar J
Language: Spanish
References: 14
Page: 339-347
PDF size: 110.29 Kb.
ABSTRACT
Introduction. Attention deficit consists of the presence of variable grades of inattention, hyperactivity and impulsivity disorder and is one of the most frequent psychopathologic disorders seen in pediatric population. Atomoxetine is a new molecule that offers a similar efficacy to other available drugs but with a broad safety for pediatric use. Objective: to establish the efficacy and safety of the atomoxetine for the treatment of the attention deficit disorder in a pediatric population.
Material and methods. Pediatric patients of both sexes, with attention deficit/hyperactivity disorder, seen in the department of neurology of the Hospital Infantil de Mexico in the period between 2003-2004 were selected, prior written informed consent by parents or guardians. The initial doses of atomoxetine were 0.5 mg/kg/day, and adjusting the doses depending on evaluation. The evaluation was made with a clinical and a functioning scale like ADHD-RS, KDSAD-S and CGI. The temporally related adverse effects were measure by anthropometry, and vitals signs.
Results. A total of 67 patients, 21 females and 46 males with a mean age of 8 years. The more frequent subtype was the combined in (54%) of the population. Twenty three percent of the patients had been previously treated for ADHD. A 78% had some type of comorbidity, the most frequent beign the defiant-oppositive disorder. The average dose of atomoxetine was 1.2 mg/kg/day, with an efficacy of 78%. The major secondary effects observed were headache, nausea and decreased of appetite, which diminished by the fourth week of treatment.
Conclusions. In these open clinical study, the atomoxetine demonstrated efficacy and safety in the control of the cardinal symptoms of ADHD in pediatric patients.
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http://www.fda.gov/cder/drug/admisory/atomoxetina.htm