Emergence of tics in children with ADHD: impact of once-daily OROS methylphenidate therapy.
OBJECTIVE
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.
Palumbo
Donna
D
Strong Neurology ADHD Medical Center, University of Rochester Medical Center, 601 Elmwood Avenue, Rochester, NY 14642-8673, USA. Donna_Palumbo@URMC.Rochester.edu
Spencer
Thomas
T
Lynch
Joseph
J
Co-Chien
Harvey
H
Faraone
Stephen V
SV
D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000150:complications* / Q000188:drug therapy; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D020323:Tics / Q000139:chemically induced* / Q000150:complications*; D014705:Verbal Behavior
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate