The purpose of this 13-study (seven double-blind/placebo-controlled, six open-label) meta-analysis is to determine the effectiveness and tolerability of long-term atomoxetine treatment among young children with attention-deficit/hyperactivity disorder (ADHD).
Data were pooled from 6- and 7-year-olds (N = 272) who met DSM-IV criteria for ADHD, received atomoxetine treatment, and were enrolled in clinical trials of > or =2 years. Of these, 97 subjects reached the 24-month time point, providing data for long-term trend analysis of safety and effectiveness.
Effectiveness for most subjects was maintained over long-term treatment, as demonstrated by total scores and total T scores on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version, investigator administered and scored. During the 2-year period, 25.7% discontinued because of lack of effectiveness, but adverse events were clinically minor and transient, and only 4.0% of children discontinued because of an adverse event. Notable effects on growth were seen during early phases of the study, with attenuation occurring by the 2-year time point. Statistically significant increases in pulse and blood pressure and decreases in cardiac PR interval were seen, but no changes were deemed both statistically significant and clinically meaningful among any vital signs, electrocardiographic measures, or laboratory tests.
Long-term atomoxetine treatment appears generally well tolerated and effective in the treatment of young children with ADHD.
"After medication washout children experience considerable loss of improvement . Kratochvil et al.  reported on the effectiveness and tolerability of long-term atomoxetine treatment. During a period of 2 years, more than 25% of young children with ADHD discontinued the treatment because of lack of effectiveness. "
[Show abstract][Hide abstract] ABSTRACT: Background
Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood. However, up to 30% of children treated with stimulants either fail to show an improvement or suffer adverse side effects, including decreased appetite, insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD. A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD, leading to e.g. significant and stable improvement in behavior, attention and IQ. Significant treatment effects of neurofeedback have also been verified in meta-analyses. Most of the trials, however, have been criticized for methodological difficulties, particularly lacking appropriate control conditions and number of patients included. This randomized study examines the efficacy of slow cortical potentials (SCP) -neurofeedback, controlling unspecific effects of the setting by comparing two active treatment modalities.
A total of 144 patients with ADHD, older than six and younger than ten years, in some cases with additional pharmacological treatment, are included in this trial. In five trial centres patients are treated either with SCP-feedback or electromyographic (EMG) -feedback in 25 sessions within 3 months. A comprehensive test battery is conducted before and after treatment and at follow-up 6 month later, to assess core symptoms of ADHD, general psychopathology, attentional performance, comorbid symptoms, intelligence, quality of life and cortical arousal.
The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study. In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables. Further, the choice of EMG-biofeedback as an active control condition is debated.
Current Controlled Trials ISRCTN76187185. Registered 5 February 2009.
"Two additional meta-analyses assessed reported the effect of longterm use of ATX on height and weight. The first showed a decrease in weight (average 2.5 kg) and in height (average 2.7 cm) after 2 years of treatment with ATX in 6–7-year-old children in relation to baseline percentiles (Kratochvil et al. 2006). The second metaanalysis reported a less evident effect on weight and height, 0.87 kg and 0.44 cm, respectively (Spencer et al. 2005). "
[Show abstract][Hide abstract] ABSTRACT: Abstract Objective: This study was conducted to assess the long-term effect of methylphenidate (MPH) or atomoxetine (ATX) on growth in attention-deficit/hyperactivity disorder (ADHD) drug-naïve children. Design: The study was an observational, post-marketing, fourth phase study. Methods: Data on height and weight were collected at baseline and every 6 months up to 24 months. Results: Both ATX and MPH lead to decreased height gain (assessed by means of z-scores); the effect was significantly higher for ATX than for MPH. At any time, height z-score decrease in the ATX group was higher than the corresponding decrease observed in the MPH group, but the difference was significantly relevant only during the first year of treatment. An increment of average weight was observed both in patients treated with MPH and in those treated with ATX. However, using Tanner's percentile, a subset of patients showed a degree of growth lower than expected. This negative effect was significantly higher for ATX than for MPH. Conclusions: We conclude that ADHD drugs show a negative effect on linear growth in children in middle term. Such effect appears more evident for ATX than for MPH.
Journal of child and adolescent psychopharmacology 09/2013; 23(7). DOI:10.1089/cap.2012.0086 · 2.93 Impact Factor
"However, when studies on ADHD are reviewed, it is worth noting that superior effect sizes compared to ATX have always been consistently noted with MPH-IR and MPH-ER (Faraone et al., 2006). In short term studies of 4-8 weeks, a greater improvement has been noted with MPH and MAS compared to ATX (Wigal et al., 2005), while in long term studies over a period 10-14 weeks or more, ATX is as efficacious as MPH (Kratochvil et al., 2006). "
[Show abstract][Hide abstract] ABSTRACT: Attention deficit hyperactivity disorder is a developmental disorder with an age onset prior to 7 years. Children with ADHD have significantly lower ability to focus and sustain attention and also score higher on impulsivity and hyperactivity. Stimulants, such as methylphenidate, have remained the mainstay of ADHD treatment for decades with evidence supporting their use. However, recent years have seen emergence of newer drugs and drug delivery systems, like osmotic release oral systems and transdermal patches, to mention a few. The use of nonstimulant drugs like atomoxetine and various other drugs, such as α-agonists, and a few antidepressants, being used in an off-label manner, have added to the pharmacotherapy of ADHD. This review discusses current trends in drug therapy of ADHD and highlights the promise pharmacogenomics may hold in the future.
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