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news.Shire has announced positive findings from a new data analysis that was conducted to examine treatment differences with Daytrana between boys and girls aged six to 12 years with attention deficit hyperactivity disorder.
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This analysis was conducted using data from an open-label, flexible dose, 12-month extension study in which 326 children received Daytrana. The primary objective of this study was to investigate the long term safety profile of attention deficit hyperactivity disorder (ADHD) treatment with Daytrana, and the secondary objective examined the efficacy of the medication between genders. In the study, the efficacy of Daytrana was measured using the ADHD Rating Scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale, and measurement results were found to be statistically significant on all scales.
In the analysis, boys had a 41% change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23% change on the scale (as calculated from a mean baseline score of 11.3, with a mean change from baseline to endpoint of -2.6). Lower scores on the ADHD-RS-IV reflect an improvement in symptom control. On the CGI-I scale, clinicians rated 83% of boys and girls ‘improved’ or ‘very much improved’ at the end of the study compared to week one. Additionally, the PGA rating scale showed that 78% of boys and girls ‘improved’ or ‘very much improved’ at the end of the study compared to week one.
The findings from the analysis reaffirmed that Daytrana has an established safety profile and effectively controlled attention deficit hyperactivity disorder (ADHD) symptoms in both boys and girls for the duration of the study.