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Observational Study
. 2015 Jun;7(2):157-64.
doi: 10.1007/s12402-014-0154-x. Epub 2014 Oct 28.

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

Fabian Haertling  1 , Beate Mueller, Oliver Bilke-Hentsch
Affiliations
Observational Study

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

Fabian Haertling et al. Atten Defic Hyperact Disord. 2015 Jun.

Abstract

Long-acting (LA) preparations of methylphenidate allow for once-daily dosing; however, pharmacokinetics may vary and depend on food intake. The objective was to evaluate effectiveness of a two-phase release formulation (Ritalin(®) LA) under daily practice conditions. This was a prospective, multicenter, observational study in Germany. Eligibility and dosing were determined by the physician based on the drug label. Outcomes included changes over 3 months of treatment in assessments of effect duration, clinical global impression (CGI), and quality of life (ILK). In 101 sites, 262 patients (197 boys, 63 girls, and two unknown) with a mean age of 10.9 years were enrolled; 50 were treated for the first time; 212 switched medication to Ritalin(®) LA. After 3 months, CGI improved in 59.4 % of patients, and well-being overall was rated as good by 61.0 % of parents and 63.7 % of children. Based on parents' assessment, the proportion of children suffering from strong disease burden decreased from 40.7 to 15.1 %. In 123 insufficient responders to previous ADHD medications, benefit from Ritalin(®) LA was above average and effect duration was significantly prolonged as compared to pretreatment. Overall, 28 patients (10.7 %) had treatment-related adverse events with one case being serious; 23 patients (8.8 %) discontinued therapy, 7 (2.7 %) due to poor treatment response; and 212 patients (81 %) continued treatment beyond the study. In line with clinical trial data, Ritalin(®) LA provides significant benefit also under routine practice conditions.

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Figures

Fig. 1
Fig. 1
Change in the three aspects of the CGI-s (inattentiveness, impulsivity, and hyperactivity) after 3 months of treatment with Ritalin® LA, as assessed by the investigator, in groups of patients who switched treatment either for “non-response” to previous treatment (n = 123) or for “other” reasons (n = 139)
Fig. 2
Fig. 2
Mean scores (0: very poor to 5: very good) of parents and children on the nine questions of the ILK at baseline and after 3 months of treatment
See this image and copyright information in PMC

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