Children achieve sustained ADHD symptom improvement with long-term, once-daily use of A...( heir ADHD symptoms during the two-year ...),Health

The 10-item CGIS-P scale monitors treatment response and effectiveness. CGIS-P total scores range from zero to 30, which decline as ADHD symptoms are better controlled. The CGIS-P scores declined throughout the study from their initial-visit score average of 11.6 to 7.6 at 24 months and study conclusion (P< 0.001), indicating that these patients were able to control their symptoms over an extended period of time. This improvement in ADHD symptoms also was documented when patients were grouped based on their pre-extension study therapy.

Specifically, the 138 children who stopped taking the study medication between the short-term trials and enrollment in this long-term extension study (i.e., they were not receiving medication at the baseline visit for the long-term study) showed significant improvement (>35 percent) from their initial average CGIS-P score their final average score (P <0.001). The 182 patients who received a placebo during the short-term trials and then received the active drug in the extension study also experienced a decrease in average CGIS-P scores (>35 percent, P <0.001.) The 228 children already receiving the drug during the short-term clinical trials and during the extension trial maintained ADHD symptom control. This last subset had already experienced an average of at least 35 percent improvement in symptom control during the short-term pivotal clinical trial prior to enrolling in this two-year extension.

"Since ADHD is a condition that requires ongoing treatment, many parents are concerned that the medication may become less effective overtime, requiring higher doses or a change of medication to maintain optimal ADHD symptom control," said McGough. "The sustained improvement using the once daily mixed salts amphetamine product i
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Contact: Michle Roy, Shire Pharmaceuticals Group plc
450-978-7938
Porter Novelli
21-May-2003