Abstract
Objectives:
While stimulants are the recognized first-line choice of pharmacotherapy for ADHD, reports that they may induce or exacerbate tics have tended to limit their use in ADHD children who have a history of tics or a family history of Tourette's syndrome. This study analyzes the incidence of tics reported across five studies of children with ADHD who received methylphenidate (MPH)-based therapy as part of the clinical development program for once-daily OROS® MPH (CONCERTA® McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA).
Methods:
Data were analyzed from three placebo-controlled, active-controlled studies (studies 1–3) lasting 1–4 weeks, and two open-label studies lasting 2 years (study 4) and 9 months (study 5), respectively. During the course of the studies, parents were asked at the end of each week of treatment (studies 1 and 2), biweekly (study 3), or monthly (for the first year of study 4, then at 3-month intervals thereafter) whether their child had experienced tics. Tics could also be reported as adverse events in the two open-label studies.
Results:
Pooled data from the three placebo-controlled studies showed that the incidence of tics was not significantly different across all three treatment groups (OROS® MPH, 4.0%; MPH tid, 2.3%; placebo, 3.7%, p = 0.5249). During the first year of the 2-year open-label study, the monthly incidence of tics remained constant, at approximately 5%. Analysis of tic episodes per patient in this study found no correlation between an OROS® MPH dose and the frequency of tic episodes. The risk of tic episodes was higher in patients with a history of tics than in those with no history of tics (33% versus 7%,p < 0.0001). However, only 2 children with a history of tics (4%) withdrew from therapy because of their tics.
Conclusions:
These data suggest that MPH-based therapy does not significantly induce or exacerbate tics in children with ADHD.
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