Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD: A multicenter, randomized prospective study

Abstract

This community-based study was designed to evaluate treatment outcomes with OROS methylphenidate (MPH) and atomoxetine in children with attentiondeficit/hyperactivity disorder (ADHD), as assessed by physicians and parents in a setting that resembles clinical practice. In a multicenter, prospective, open-label study, children 6 to 12 years of age with ADHD were randomized (2:1, respectively) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine. Investigatorrated measures of symptoms included the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made at baseline and during a telephone interview in week 1, a clinic visit in week 2, and a final clinic visit in week 3. In total, 1323 patients received OROS MPH (n = 850) or atomoxetine (n = 473). Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine. At the end of the study, mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine (P < .001). Between-treatment differences appeared to increase over time (2.77, 3.44, and 4.24 at weeks 1, 2, and 3, respectively; P < .001). Treatment response (ie, 25% reduction from baseline ADHD-RS scores) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine (P < .001). Similar percentages of patients taking OROS MPH (4.8%) and atomoxetine (5.5%) withdrew because of adverse events. Although community-based studies often lack the control of randomized, placebo-controlled trials, these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine.

A systematic review and economic model of the effectiveness and cost-effectiveness of methylphenidate, dexamfetamine and atomoxetine for the treatment of attention deficit hyperactivity disorder in children and adolescents

“…This parallel study by Kemner and colleagues 64 reported a significant improvement in favour of MPH when measured using the ADHD Rating Scale for hyperactivity (Table 63). Similarly, the authors reported that CGI -Improvement responder rates were significantly better for the MPH group than for the ATX group (68.6 versus 52.8%, p < 0.001).…”

“…A cost-utility analysis (classified CIC) was conducted based on the results of two recent randomised, open-label studies comparing Concerta XL with IR-MPH 90 and ATX 99 and the MTA trial. 133 The model took the form of a decision tree with a time horizon of 1 year, and was conducted from the perspective of the UK NHS.…”

“…The effectiveness evidence was based on only three trials, 90,99,133 out of 65 potentially relevant studies identified in the clinical effectiveness review in Chapter 4. The justification for ignoring the majority of the RCT data was that double-blind, double-dummy trials cannot assess the effectiveness of a once-daily extended release formulation of IR-MPH in comparison with twice-or three times daily administration of IR-MPH as both arms receive the same number of pills.…”

“…Janssen-Cilag argue that compliance to a product given once in the morning may be higher than one needing to be taken during the school day, and hence they make use of two open-label pragmatic randomised trials. 90,99 …”

Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

“…The effect size at 6 weeks of 0.55 had increased in almost linear manner to 0.82 at 12 weeks (Montoya et al, 2009). Thus, some of the earlier studies cited to support superior efficacy of MPH over ATX and being only of 3-6 weeks duration may not have been long enough to show the maximal ATX efficacy (Kemner et al, 2005;Newcorn et al, 2008).…”