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Dexmethylphenidate extended release at daily doses as high as 30 mg yields improvements in teacher-rated reports of children with ADHD

Monday, October 29 2007 | Comments
Evidence Grade 0 What's This?
Dexmethylphenidate extended release is effective in treating children with attention-deficit/hyperactivity disorder, according to the results of a double-blind, fixed-dose titration trial.

Researchers randomized 253 pediatric patients aged 6 to 12 years with ADHD to 1 of 4 treatment arms.  Following a washout period, the children received placebo or dexmethylphenidate extended release in doses that were escalated from 5 mg/day the first week to 10 mg/d the second week; from there, active treatment was either maintained at 10 mg/d or was titrated upward to 20 mg or 30 mg during the next 2 weeks. The entire treatment period lasted 5 weeks.

The Conners' ADHD/DSM-IV Scale for teachers (CADS-T) was used to assess treatment efficacy.

A total of 240 patients who received >=1 dose of the study drug and had >=1 postbaseline CADS-T assessment were included in the efficacy analysis; 245 of the patients were evaluated for drug safety.

Relative to the placebo arm, the patients who received 10 mg, 20 mg, or 30 mg doses of dexmethylphenidate extended release exhibited significantly greater adjusted mean changes from baseline in the DSM-IV total subscale score of the CADS-T (primary efficacy variable; P<.001 for each group vs placebo). This superiority of the study drug relative to placebo also occurred on the DSM-IV inattentive and hyperactive/impulsive subscale scores of the CADS-T (P<.001 for each group vs placebo).

The incidence of adverse events was similar for all treatment arms: 57% with placebo, 63% with 10 mg of dexmethylphenidate extended release, 58% with 20 mg, and 71% with 30 mg. Upper abdominal pain, decreased appetite, and headache were the most common adverse events; the incidence of metabolic/nutritional and psychiatric adverse events were slightly higher with dexmethylphenidate extended release (18% and 25%, respectively) than with placebo (5% and 8%).

Among the patients who received active therapy, there were clinically notable high values for bilirubin in 3.0% of the patients, potassium in 5.1% of the patients, and alkaline phosphatase in 3.2% of the patients versus no elevations in these values among the placebo-treated patients; however, the study investigators considered none of the laboratory abnormalities to be clinically significant. Only the patients treated with dexmethylphenidate extended release experienced clinically notable weight loss (>=7% reduction from baseline), but this is consistent with known adverse effects of racemic methylphenidate and dexmethylphenidate, the authors said. (Childress A, et al. Poster B55.)

This information may concern a use that has not been approved by the Food and Drug Administration.

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