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12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA,(methylphenidate transdermal system)

ts. The highest percentage of discontinuations were due to withdrawn consent or lost to follow-up (12 percent and 11 percent, respectively).

The most commonly reported treatment-emergent adverse events reported throughout the study (.10 percent) included decreased appetite, headache, upper respiratory tract infection, cough, pyrexia and decreased weight. Most (98 percent) adverse events were mild or moderate in severity and consistent with known effects of methylphenidate. Three serious adverse events were reported and all were considered unrelated to DAYTRANA use.

DAYTRANA Demonstrated Significant Improvements in ADHD-RS-IV, CGI-I and PGA Scores

In the study, the children experienced a significant overall mean reduction in their ADHD Rating Scale-IV (ADHD-RS-IV) total score. When the study began, the mean total score on the ADHD-RS-IV was 25.0. When using Daytrana, the mean ADHD-RS-IV total scores declined, with children averaging 15.4 at study end. The overall mean change in ADHD-RS-IV total score from study start to end was -9.3 (+/- 16.29) and was statistically significant (P<.0001). The total scores also declined significantly from study start to end on both the inattentiveness and hyperactivity/impulsivity ADHD-RS-IV subscales (P<.0001).

Investigators evaluated DAYTRANA's overall effectiveness using the Clinical Global Impressions-Improvement (CGI-I) and Parent Global Assessment (PGA) scales, both of which yielded significant ratings of improvement at study end, with 83 and 78 percent, respectively, reporting DAYTRANA "very much improved" or "much improved" the children's ADHD symptoms (P<.0001).

The study was supported by funding from Shire.

About ADHD

Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the mos
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