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Extended-release dexmethylphenidate effective in controlling ADHD in children with combined subtype

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
A post hoc, pooled analysis determined that extended-release formulations of dexmethylphenidate (d-methylphenidate-ER) and d,l-methylphenidate (d,l-methylphenidate-ER) effectively control attention-deficit/hyperactivity disorder symptoms in children with the combined subtype of ADHD. A trend toward efficacy was also seen among children with the inattentive subtype, but the sample size was too small to draw firm conclusions.

A total of 166 children aged 6 to 12 years participated in 2 randomized, double-blind studies of d-methylphenidate-ER and d,l-methylphenidate-ER. All children were diagnosed with ADHD according to DSM-IV-TR criteria. Of these children, 152 were classified as having ADHD combined subtype and 14 as having ADHD inattentive subtype. For both studies combined, 110 (66%) of the children were boys.

The 5-arm crossover study included a 7-day washout period between arms. The children were treated with d-methylphenidate-ER 20 mg/day and 30 mg/d, d,l-methylphenidate-ER 36 mg/d and 54 mg/d, and placebo. Each treatment lasted 7 days. Children received 6 of their 7 doses at home. The final dose was given in a laboratory classroom after predose assessment of classroom behavior, and children were assessed in the classroom for 12 hours.

Classroom assessment was conducted using the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP), and the number of problems that were attempted and completed correctly in a 10-minute math assessment test.

SKAMP combined scores improved from the predose ratings for d-methylphenidate-ER and d,l-methylphenidate-ER in both groups (combined subtype, P<.0001; inattentive subtype, P<.05). Scores worsened with placebo. Between-treatment comparisons among children with the ADHD combined subtype showed a slight advantage for d-methylphenidate-ER in the SKAMP combined, attention, and deportment scores as compared with d,l-methylphenidate-ER.

Math attempted and correct numbers improved with the active treatments as compared with placebo at most timepoints throughout the day among children with the combined subtype (P<=.001). In the math assessment, d-methylphenidate-ER showed an earlier onset of improvement than did d,l-methylphenidate-ER in both subtype groups.

The investigators concluded that once-a-day d-methylphenidate-ER is effective for treatment of the combined subtype of ADHD in children, and may have greater efficacy than does d,l-methylphenidate-ER. Further study with a bigger sample size is necessary to determine the efficacy of d-methylphenidate-ER in the inattentive subtype of ADHD. (Silva R, et al. Poster NR674.)

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