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

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.

Changes in behavior as side effects in methylphenidate treatment: review of the literature

“… 18 , 27 , 34 – 39 , 46 , 52 , 57 , 62 , 63 Six of the studies included both methylphenidate-naïve participants and participants with prior exposure to methyl-phenidate. 21 , 26 , 54 – 56 , 58 …”

“…Nineteen of the studies were funded by pharmaceutical companies. 18 , 21 , 24 , 25 , 27 – 29 , 31 – 33 , 44 , 49 , 51 , 54 , 56 , 58 , 61 , 65 , 66 Ten were funded using government or university funding. 19 , 23 , 34 – 39 , 43 , 45 , 47 , 48 , 50 , 52 , 64 Four of the studies declared only conflict of interest, 15 , 17 , 26 , 40 – 42 , 64 Five were not in receipt of funding, 16 , 22 , 53 , 57 , 62 while six failed to provide information on funding arrangements.…”

“… 33 , 40 – 42 , 46 , 50 Ten of the studies did not include a comparison group. 16 – 18 , 31 , 53 , 56 , 58 – 60 , 62 …”

Methylphenidate and Crime Reduction

“…On the contrary, the MTA study with 579 ADHD subjects, as well as other follow-up studies (Satterfield et al 2007), validated the high efficacy of methylphenidate even without cognitive behavioral therapy (see Banaschewski 2009). New studies show the improved efficacy of the long-acting, two-phase methylphenidate preparations now used (Haertling et al 2015). A meta-analysis of the life span studies shows that in addition to the severity of ADHD, the treatment is the predictor of persistence of deviant behavior .…”

Comparison between Actigraphic Records, the Evaluation of Behavior and Attention, and the Use of Psychostimulants in ADHD Patients: A Pilot Study

“…Adequate control of these behaviors has been highly related to quality of life improvements among the child and those around them, especially when pharmacological treatment with psychostimulants is introduced. In these instances, we see an almost immediate reduction in hyperactivity, excessive inattention, and other externalized symptoms (Brown et al, 2005;Haertling, Mueller, & Bilke-Hentsch, 2015;Zelnik & Terkel-Dawer, 2015). In order to objectively measure the hyperkinetic behavior of patients with combined ADHD, an actigraphic device, or an actimeter, can be used.…”