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Methylphenidate Transdermal Patch Demonstrates Cardiovascular Safety in Children With Attention-Deficit Hyperactivity Disorder: Presented at AACAP

By Maria Bishop

BOSTON, MA -- October 31, 2007 -- Children with attention-deficit hyperactivity disorder (ADHD) using the methylphenidate transdermal patch for up to 12 months experience few clinically significant changes in cardiac function, according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP).

Methylphenidate has been used to treat ADHD for more than 30 years, with minor effects on blood pressure or heart rate.

The cardiovascular effects of long-term use of the transdermal patch were studied recently by researchers led by Robert L. Findling, MD, Director, Child and Adolescent Psychiatry Center and Discovery & Wellness Center for Children, University Hospitals Case Medical Center, Cleveland, Ohio, United States.

Overall, 327 children aged 6 to 12 years and diagnosed with ADHD who previously participated in studies with the methylphenidate transdermal system were enrolled in an open-label, flexible-dose, 12-month extension trial. Patch doses were 10 mg, 15 mg, 20 mg and 30 mg. The patches were applied each morning and were worn for approximately 9 hours each day.

During the dose-optimisation phase, titration to a higher dose was permitted after a minimum of 3 days; tapering to a lower patch size was also allowed. During the dose-maintenance period, clinic visits or in-between visits were made if deemed necessary by the investigator. Clinic visits were generally scheduled every 30 days (range, 23-37 days).

Treatment-emergent adverse events that were potentially attributable to cardiac function were reported in six subjects with abnormal vital signs: three subjects with increased heart rate; one with a decrease in blood pressure; two with increased blood pressure (one of whom discontinued the study).

Treatment-emergent adverse events related to electrocardiogram (ECG) readings were noted, but none led to study discontinuation: one case of prolonged QT interval; two cases of sinus tachycardia; two cases of tachycardia; one case of tachycardia with palpitations. No trends in ECG readings were considered to be of clinical importance.

All cardiovascular events were considered mild or moderate in severity, and varied from visit to visit.

Funding for this study was provided by Shire Pharmaceuticals Group plc


[Presentation title: Cardiovascular Effects of the Methylphenidate Transdermal System in ADHD Subjects: Abstract B4]

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