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Methylphenidate transdermal system shows similar efficacy in male, female children with ADHD, although males may face greater risk of adverse events

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
The methylphenidate transdermal system (MTS) appears to be similarly effective in male and female children with attention-deficit/hyperactivity disorder, although males may face a higher incidence of adverse events, study data indicate.

Researchers conducted a double-blind, placebo-controlled, parallel-group study in which 282 children with ADHD were randomized to 1 of 3 treatment groups: those who received placebo capsule plus MTS (MTS group; n=100), those who received OROS methylphenidate capsule plus placebo patch (OROS methylphenidate group; n=94), and those who received placebo capsule plus placebo patch (placebo group; n=88). Overall, 274 subjects received >=1 dose of their study drug (182 males and 92 females; MTS, n=98; OROS methylphenidate, n=91; placebo, n=85).

All patients underwent a 2-week screening and washout period, a 5-week double-blind stepwise dose-optimization phase, a 2-week maintenance phase, and a 30-day follow-up period after drug cessation. Dosing was started at the lowest available dose (10 mg patch and 18 mg capsule) and was titrated up to an optimal dose, defined as the dose at which patients achieved a 25% reduction in ADHD Rating Scale-IV (ADHD-RS-IV) scores with minimal side effects.

Results showed that, from baseline, patients in both the MTS and OROS methylphenidate groups achieved significant reductions in total ADHD-RS-IV scores, the primary endpoint, relative to placebo (P<.0001). Efficacy was not significantly different between male and female children in either group.

The most common treatment-emergent adverse events in both male and female children included decreased appetite, headache, insomnia, nausea, and vomiting. Ninety-nine percent of all adverse events were mild to moderate in intensity, the authors noted.

In the MTS group, male children had a higher incidence of vomiting (15% vs 3%), tic (12% vs 0%), upper abdominal pain (10% vs 3%), irritability (12% vs 0%), and affect lability (10% vs 0%) relative to female children, while decreased weight was more common among female children than among male children (15% vs 5%). Four male patients in the MTS group discontinued treatment due to adverse events compared with 3 female children.

"Overall, more males (83%) treated with MTS reported adverse events than females (64%) treated with MTS," the authors concluded. "Treatment-emergent adverse events in the MTS-treated subjects were similar to those reported for other methylphenidate products." (Findling RL, et al. Poster 110.)

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