Abstract
Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDSTeacher: 0.97 with minimal breakfast, 1.01 with standard breakfast, P < 0.0001). The clinical efficacy of Ritalin LA is not influenced by breakfast and works independently of food intake.
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Acknowledgments
The authors would like to thank all investigators and co-investigators from the 13 participating study sites for the Breakfast Study Group as well as Mrs. Clement for creating the different breakfast schedules. This study was sponsored by Novartis Pharma GmbH, Germany.
Conflict of interest
Eberhard Schulz: received grants from BMBF, Eli Lilly, Janssen-Cilag, Novartis, Pfizer and Shire.
Christian Fleischhaker received grants from Bristol-Myers Squibb (Advisory Board).
Frank Haessler M.D.:
Advisory Board: Eli Lilly GmbH Germany, Janssen-Cilag
Research Support: Eli Lilly GmbH Germany, Janssen-Cilag, Novartis Pharmaceuticals, Bayer Vital
Travel Grants: Novartis Pharmaceuticals, AstraZeneca Pharmaceutical, UCB
Consulting Fees: Janssen-Cilag, Novartis Pharmaceuticals, UCB
Honoraria: UCB
Andreas Warnke received grants for scientific presentations, pharmacological research and scientific meetings from Astra-Zeneca, Eli Lilly, Janssen-Cilag, Medice, Novartis, Sanofi, Shire, Solvay and UCB.
Klaus Hennighausen, Martin Linder and Kirsten Stollhoff have received financial compensation from the sponsor for participation in this trial. Monika Baier, Ferenc Tracik and Jan Klatt are employees of Novartis Pharma GmbH, Germany.
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This study is conducted on behalf of the Breakfast Study group.
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Schulz, E., Fleischhaker, C., Hennighausen, K. et al. A randomized, rater-blinded, crossover study comparing the clinical efficacy of Ritalin® LA (methylphenidate) treatment in children with attention-deficit hyperactivity disorder under different breakfast conditions over 2 weeks. ADHD Atten Def Hyp Disord 2, 133–138 (2010). https://doi.org/10.1007/s12402-010-0031-1
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DOI: https://doi.org/10.1007/s12402-010-0031-1