( o helpmanage the potential for late-da...)Daytrana (methylphenidate transdermal system) Provides Significant,Effectiveness in ADHD Symptom Relief in Both Boys and Girls,Health

Significant Symptom Control for Boys and Girls

In this double-blind, 7-week, parallel-group study, investigators randomized 270 children to receive DAYTRANA, OROS methylphenidate or placebo. The 96 children (ITT population) in the DAYTRANA group reported a significant mean reduction of 56.5 percent in their ADHD Rating Scale-IV (ADHD-RS-IV) total scores (-24.24±14.55 points, P<.0001 vs. placebo) from the study start to end, the study's primary endpoint.

The 58 boys that received DAYTRANA averaged a significant 56 percent ADHD- RS-IV total score reduction (-24.28±15.66 points, P<.0001), while the 38 girls averaged a significant 57.4 percent reduction (-24.18±12.88 points, P<.0001).

ADHD-RS-IV assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)), a publication of the American Psychiatric Association.

Investigators monitored adverse events throughout the study and for 30 days after the last dose. Adverse events typically were mild to moderate in severity and were consistent with known effects of methylphenidate. No serious adverse events were reported.

The most common treatment-emergent adverse events (>10 percent) in both boys and girls in the trial were decreased appetite, headache, insomnia, nausea and vomiting. Boys in the DAYTRANA group had a higher incidence of vomiting (9 boys vs. 1 girl), tic (7 vs. 0), upper abdominal pain (6 vs. 1), irritability (7 vs. 0) and affect lability (6 vs. 0).

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 CDC. ADHD is one of the most common psychiatric disorders in children and a
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