title: [Atomoxetine safety and efficacy in children with attention deficit/hyperactivity disorder (ADHD): initial phase of 10-week treatment in a relapse prevention study with a Spanish sample].
abstract: BACKGROUND
  Attention-deficit/hyperactivity disorder (ADHD) appears to be associated to problems with regulation of cortical dopaminergic/noradrenergic function. The purpose of this work is to present efficacy and safety data from 10-week open label treatment with atomoxetine, a highly selective norepinephrine reuptake inhibitor, in a Spanish sample of children and adolescents with ADHD participating in a double-blinded, placebo-controlled, multinational study on relapse prevention.
  
  
  METHODS
  Sub-analysis of data in 36 children and adolescents aged 6 to 15 years, with diagnosis of ADHD (DSM-IV) included in Spain, receiving open-label treatment with atomoxetine for 10 weeks and assessed using ADHD-RS, CGI-ADHD-S, CPRS-R:S, CTRS-R:S y CHQ-PF50.
  
  
  RESULTS
  After 10 weeks of treatment with atomoxetine, statistically significant reductions in ADHD-RS, CGI-ADHD-S, CPRS-R:S and CTRS-R:S scores were obtained in both subtypes; 87.5 % of inattentive patients and 82.14 % of patients with combined subtype were responders. No recurrences were observed. No serious adverse event-driven discontinuations occurred, and no statistically significant changes in blood pressure, but a mild increase in heart rate (p < 0.0001) were observed.
  
  
  CONCLUSIONS
  In general, atomoxetine was well tolerated and effective in the open phase in Spanish patients, both for inattentive and combined subtypes. Atomoxetine appears as a non-stimulant therapeutic alternative for the treatment of ADHD.
authors.affiliation: Departamento Médico, Lilly Research Laboratories, Alcobendas, Madrid. escobar_rodrigo@lilly.com
authors.forename: R
authors.initials: R
authors.lastname: Escobar
authors.forename: C
authors.initials: C
authors.lastname: Soutullo
authors.forename: J
authors.initials: J
authors.lastname: San Sebastián
authors.forename: E
authors.initials: E
authors.lastname: Fernández
authors.forename: I
authors.initials: I
authors.lastname: Julián
authors.forename: F
authors.initials: F
authors.lastname: Lahortiga
mesh_terms: D000293:Adolescent; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000517:prevention & control*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*; D012008:Recurrence; D013030:Spain; D013997:Time Factors
chemical_list: D011437:Propylamines; D000069445:Atomoxetine Hydrochloride