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OROS Formulation of Methylphenidate Does Not Worsen Tics in Children with Attention Deficit/Hyperactivity: Presented at ANA

By Jill Stein

SAN FRANCISCO, CA -- October 24, 2003 -- Long-term therapy with once-daily osmotic release oral system (OROS) methylphenidate (Concerta) has minimal, if any, impact on tics in children with attention-deficit/hyperactivity disorder (ADHD), researchers reported here on October 20^th at the 128^th Annual Meeting of the American Neurological Association.

Donna Palumbo, MD, and colleagues, University of Rochester, Rochester, New York, United States, treated 407 children with ADHD using 18 mg, 36 mg, or 54 mg methylphenidate, taken once a day. Children with a history of mild or moderate tics were eligible for enrollment in the study.

"Attention-deficit/hyperactivity disorder and tic disorders are both common neurobehavioural disorders in children and frequently occur together," Dr. Palumbo pointed out. "While stimulants are the recommended first-line pharmacotherapy for ADHD, controversy surrounds their use in children with ADHD who are considered at risk of tic disorders due to concerns that stimulants may induce or exacerbate tics."

She added that these concerns are based on a limited number of studies that did not take into account the natural history of the disorders and which are contradicted by other research.

During the first year of her study, Dr. Palumbo and colleagues found that the incidence of tics remained constant at about 5% per month, and most tics were not new in onset. Parental monthly reports over the first year indicated that in most cases the severity of tics remained unchanged or decreased from the prior month.

During the 2-year study, 63 tic episodes were reported as adverse events in 9.8% of children -- most were reported during the first year.

Most tics were mild or moderate in severity, and the mean total duration was similar for both mild and moderately severe tics, with 116 days and 108 days for mild and moderately severe tics, respectively.

The risk of a tic episode was low, at 7%, in children with no history of tics. Even among those with a known history of tics, only one in three reported tics as an adverse event over the course of the study.

Overall, the results suggest that long-term therapy with OROS methylphenidate has a negligible impact on tics in children with ADHD, Dr. Palumbo said.

The study was supported by McNeil Consumer & Specialty Pharmaceuticals.


[Study title: Once-Daily Dosing With the ORORS Formulation of Methylphenidate Has Minimal Impact on Tics in Children with ADHD. Abstract 24]

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