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

Introduction. 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.

Patients and 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, CGIADHD-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 appearsas a non-stimulant therapeutic alternative for the treatment of ADHD.