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OROS methylphenidate safe, effective in adults with ADHD, trial data show

Wednesday, December 12 2007 | Comments

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What's This? OROS methylphenidate appears safe and effective in adults with attention-deficit/hyperactivity disorder, eliciting dose-dependent improvements in inattention and hyperactivity/impulsivity symptoms, according to findings from the double-blind LAMDA trial.

Researchers randomized 401 adult patients with ADHD and a Conners' Adult ADHD Rating Scale (CAARS) score of >=24 at screening to receive placebo (n=96) or OROS methylphenidate in doses of 18 mg/day (n=101), 36 mg/d (n=102), or 72 mg/d (n=102) for 5 weeks. All individuals enrolled in the trial underwent a screening and washout period for up to 4 weeks before randomization. All treatments were administered once daily in the morning.

The study was designed to assess the safety and efficacy of OROS methylphenidate in adults with ADHD. The primary efficacy measure was the change in the sum of the CAARS inattention and hyperactivity/impulsivity subscale scores (CAARS total score) from baseline to week 5.

Results showed that, of the total population randomized and treated, 365 patients (91%) completed double-blind treatment (intent-to-treat analysis, n=394). The primary reasons for withdrawal from the study were adverse events (n=12; 3%) and withdrawal of consent (n=8; 2%).

At week 5, all OROS methylphenidate groups had significantly greater improvements in CAARS total score relative to the placebo group (P<.05). Between-group differences reached statistical significance starting in week 1, the authors noted.

Effect sizes were dose-dependent; specifically, the effect size was 0.38 among patients who received the 18 mg/d dose, 0.43 among those who received the 36 mg/d dose, and 0.62 among those who received the 72 mg/d dose.

Changes in the Clinical Global Impression (CGI)-Severity score from baseline to week 5, a secondary endpoint, were also significantly greater among OROS methylphenidate-treated patients than among those who received placebo (P<.005 for all 3 doses). Similarly, at week 5, CGI-Global Change scale scores were significantly better in the OROS methylphenidate groups than in the placebo group (18 mg/d dose, P=.0004; 36 mg/d dose, P=.0108; 72 mg/d dose, P<.0001).

At week 5, OROS methylphenidate-treated patients had significantly greater improvements in self-report CAARS scores (P<.005 for all 3 doses vs placebo) and greater improvements in Sheehan Disability Scale scores (18 mg/d vs placebo, P=.0085; 36 mg/d vs placebo, P=.0607; 72 mg/d vs placebo, P=.0037) as compared with the placebo group.

Additionally, 50.5% of the 18 mg/d group, 48.5% of the 36 mg/d group, and 59.6% of the 72 mg/d group met criteria for a response to treatment (>=30% decrease in CAARS total score) compared with 27.4% of the placebo group (P=.002, P=.0074, and P<.0001, respectively).

The most common adverse events reported with active treatment included decreased appetite, headache, insomnia, nausea, and dry mouth. Four individuals in the trial experienced a serious adverse event, including cerebrovascular accident, anxiety disorder, depression, and migraine, although only depression was considered possibly related to therapy. Small but statistically significant increases in blood pressure and pulse rate were observed with OROS methylphenidate, the authors added.

Results from the trial were similar to those obtained in trials of children, Dr. Rossella Medori, the lead researcher, told VerusMed.

"We're getting the same thing in adults as children with no safety difference whatsoever," she remarked. (Poster 205.)

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