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OROS methylphenidate safely treats adult ADHD, trials show

Tuesday, October 30 2007 | Comments
Evidence Grade 0 What's This?
OROS methylphenidate is a safe and effective treatment for adult attention-deficit/hyperactivity disorder, according to an analysis of interim data from a long-term, open-label safety trial and data from a randomized, placebo-controlled, dose-titration study.

In the open-label safety study, OROS methylphenidate was initiated at a dose of 36 mg/day, which could be increased by 18 mg/d in weekly increments based on efficacy and tolerability (maximum dose, 108 mg/d); of 368 participants enrolled, 358 received >=1 dose of the drug.

At the interim analysis, the mean final dose of OROS methylphenidate was 67 mg/d; the mean duration of drug exposure was 120.5 days (range, 1-250 days). A total of 189 subjects (52.8%) had withdrawn from the study, including 92 who withdrew due to adverse events.

Overall, 91.1% of participants experienced treatment-emergent adverse events. The authors noted that OROS methylphenidate was associated with a mean weight loss of 1.6 kg and an increase in mean heart rate of 3.3 bpm, but there was no clinically relevant effect of the drug on blood pressure.

Adverse events reported by subjects included decreased appetite (27.4%), headache (23.2%), insomnia (22.9%), dry mouth (15.6%), anxiety (14.5%), and increased heart rate (11.2%). There were 5 serious adverse events, none of which was considered related to the study drug. There were no deaths during the trial.

In the controlled trial, adults with ADHD were randomized in a 1:1 ratio to receive OROS methylphenidate (n=110) or placebo (n=116). The drug was initiated at a dose of 36 mg/d and was increased by 18 mg/d in weekly increments until prespecified criteria for response were met or the maximum dose (108 mg/d) was reached. The dosage could also be reduced, depending on tolerability.

OROS methylphenidate was associated with a significantly greater change from baseline in Adult ADHD Investigator Symptom Rating Scale scores as compared with placebo (-10.6 vs –6.8; P=.012).

Overall, 84.5% of the OROS methylphenidate group reported adverse events compared with 63.8% of the placebo group; 14.5% and 5.2% of subjects, respectively, withdrew due to adverse events.

Adverse events that occurred in >=10% of the OROS methylphenidate group and occurred more frequently in this group (relative to the placebo group) included decreased appetite (25.5% vs 6.0%), headache (25.5% vs 13.8%), dry mouth (20.0% vs 5.2%), anxiety (16.4% vs 3.4%), nausea (12.7% vs 2.6%), and increased blood pressure (10% vs 5.2%). There were no deaths or treatment-emergent serious adverse events. (Berry SA, et al. Poster D9.)

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

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