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Transdermal methylphenidate effectively treats ADHD, improves quality of life in children who switch from ER methylphenidate, research reveals

Thursday, December 13 2007 | Comments

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What's This? The methylphenidate transdermal system (MTS) is a safe and effective treatment for children with attention-deficit/hyperactivity disorder, new study findings indicate. Study data also suggest treatment with MTS may reduce the impact of ADHD on both the child and his or her family relative to treatment with oral, extended-release formulations of methylphenidate.

A total of 171 children, aged 6 to 12 years, were enrolled in this prospective, open-label, 4-week multicenter study (mean age, 9.4 years). All participants had ADHD according to DSM-IV-TR criteria and were taking a stable dose of an extended-release formulation of methylphenidate for ≥30 days prior to their initial screening. The children's parents or legal guardians were considering a change in ADHD medication due to problems with efficacy, tolerability, or compliance.

Using a predetermined dose transition schedule, children initiated treatment with an MTS dose that was selected based on their prior dose of oral methylphenidate. After the first week of treatment, dose adjustment was allowed during the next 2 weeks of the trial. At the end of week 3, the patient's dose was maintained for the last week of treatment. Patches were applied each morning and were worn for approximately 9 hours. Adverse events were assessed at each visit during the study and at 30 days after administration of the last dose.

Efficacy was assessed using the ADHD Rating Scale-IV (ADHD-RS-IV; completed at each visit), the Attention Deficit/Hyperactivity Disorder Impact Module–Children (AIM-C; completed at baseline and at week 4), and the Medication Satisfaction Survey (MSS; completed by parents and physicians at the final visit).

In the intent-to-treat analysis (n=164), ADHD-RS-IV total scores declined significantly from baseline to endpoint (P<.0001). In addition, AIM-C scores improved from baseline, suggesting the impact of the disorder was reduced with MTS. Improvement in AIM-C scores was observed regardless of the formulation of extended-release methylphenidate used at baseline, the researchers noted.

Based on their own observations, 89% to 96% of physicians "agreed" or "strongly agreed" with MSS statements regarding physician satisfaction with treatment and physician impressions of treatment effectiveness. MSS responses also showed that a majority of parents agreed or strongly agreed with statements regarding their satisfaction with the treatment's effect on overall behavior (79%), effect on attention (80%), ease of use (86%), and daily dosing schedule (94%). Overall treatment satisfaction was reported by 79% of parents.

In the safety analysis (n=171), most adverse events were mild to moderate in severity and consisted mainly of headache, decreased appetite, upper abdominal pain, and insomnia. A 12-year-old girl, however, experienced severe depression and attempted suicide while taking the study medication (dose, 30 mg/d). It is possible her reactions were related to MTS, the investigators noted. (Landgraf JM, et al. Poster NR662).

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