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Long-term treatment with lisdexamfetamine safe, effective in children with ADHD

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
A long-term study of children with attention-deficit/hyperactivity disorder shows that treatment with lisdexamfetamine appears to be safe and effective.

The open-label, single-arm study included 272 children aged 6 to 12 years with the combined and hyperactive/impulsive subtypes of ADHD. Most of the children (n=271) were previously part of a double-blind lisdexamfetamine study, and may have been treated with lisdexamfetamine prior to the open-label study.

During a period of 4 weeks, the children's lisdexamfetamine dose was titrated up to 30 mg/day, 50 mg/d, or 70 mg/d. The children were treated for up to an additional 11 months beyond the initial 4 weeks. Dose adjustments were allowed at the treating physician's discretion, but the final dose did not go above 70 mg/d. The intent-to-treat population consisted of 189 boys and 83 girls.

Primary effectiveness was measured by changes from baseline on the ADHD Rating Scale (ADHD-RS) and secondary effectiveness was measured by the Clinical Global Impression scale (CGI). Safety was assessed through laboratory tests, electrocardiograms and vital signs, physical examination, and the occurrence of adverse events.

The mean baseline value of the ADHD-RS was 43.3. The mean change at study endpoint was -27.2 (P<.0001). More than 80% of the intent-to-treat participants were rated as improved on the CGI.

In addition, more than 95% of adverse events were mild to moderate and consisted mainly of insomnia, decreased appetite, weight loss, headache, abdominal pain, irritability, and upper respiratory infection. The majority of these events occurred in the first 8 weeks of treatment. (Childress AC, et al. Poster NR739.)  

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