An observational study of once-daily modified-release methylphenidate in ADHD: effectiveness on symptoms and impairment, and safety

Abstract

ADHD affects over 5% of children worldwide. It is typically treated with stimulant medications, and methylphenidate (MPH) is the most commonly prescribed. This study investigated the effectiveness, on symptoms and impairment, and safety of Equasym XL®, a combination of 30% immediate-release and 70% modified-release MPH, in the treatment of ADHD in daily clinical practice. This open-label, observational, post-marketing surveillance study was conducted in 169 centres in Germany. Eligible patients, aged 6–17 years, were diagnosed with ADHD and about to begin treatment with Equasym XL®. Effectiveness was assessed by physicians using the clinical global impression (CGI) severity and improvement scales; teachers and parents completed questionnaires evaluating ADHD symptoms and behavioural problems (DAYAS, FBB-ADHD and SDQ-P). Assessments were carried out at baseline, after 1–3 and 6–12 weeks of treatment. Of 852 enrolled patients, 822 were evaluable; 25.30% were treatment naïve, 69.84% had previously received different MPH formulations, and 4.87% had received other medications. ADHD symptoms improved from baseline to last visit for the majority of patients for all outcome measures. According to physician ratings of core ADHD symptoms, 75.73% of patients showed improvements on the CGI-Improvement scale, 17.77% had no change, and 6.50% worsened. In teacher and parent ratings, the effectiveness of Equasym XL® was rated better than prior therapy at all measured time points across the day, particularly late morning (teachers) and early afternoon (parents). Equasym XL® was generally well tolerated; only 3.16% of patients permanently discontinued treatment due to adverse events. Equasym XL® is effective and well tolerated in daily clinical practice.

Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin® LA) in school children under daily practice conditions

“…It demonstrated improvements in ADHD symptoms and QoL, confirmed overall good tolerability and safety, and revealed a longer perceived effect duration versus previous treatments. Comparable results regarding safety and effectiveness of other sustained release MPH formulations in daily practice have already been reported, particularly after switching from immediate release formulations (Dopfner et al 2011a , 2011b ; Rothenberger et al 2011 ). However, to our knowledge, a significant prolongation of the perceived effect under such conditions is described here for the first time, although recently a change in the daily course of ADHD symptoms after switching to another LA formulation has been reported under routine practice conditions too (Froelich et al 2014 ).…”

An observational study of response heterogeneity in children with attention deficit hyperactivity disorder following treatment switch to modified-release methylphenidate

“…This analysis sought to identify and determine the distinctive features of clusters of patients with different response trajectories to treatment with MR-MPH in parent and teacher ratings under real world conditions using data from the OBSEER study [32]. …”

An evaluation of the pharmacokinetics of methylphenidate for the treatment of attention-deficit/ hyperactivity disorder

“…methylphenidate transdermal system Daytrana Ò showed equivalent 12-h duration of action as d-l-MPH-OROS [129]. The effects of Concerta and Medikinet XL were compared over the course of a day, in a recently published controlled study [130]. Here, Medikinet XL which has a higher IR component than Concerta and a virtually equivalent daily dose was more effective than Concerta in the first 3 school h. A lower dose of Medikinet XL with a similar IR component in the morning as Concerta was not inferior in efficacy to Concerta.…”