Objective: The aim of this study was to evaluate the efficacy and safety of OROS-methylphenidate (OROS-MPH) compared with immediate-release methylphenidate (IR-MPH) in Turkish children with attention deficit hyperactivity disorder (ADHD).
Method: The medical records of primary school-aged children (7-14 years old), who were first-time referrals to the outpatient clinic, were reviewed, and 67 children receiving OROS-MPH (18-54 mg once daily) and 47 children receiving IR-MPH (15-60 mg in divided doses) were recruited for the study, for a total of 114 children receiving treatment for ADHD over 8 weeks. Baseline and 4- and 8-week assessment records were reviewed. Efficacy assessments included the Turgay DSM-IV ADHD Screening and Rating Scale (T-DSM-IV), parent and teacher forms, and the Clinical Global Impression - Improvement and Severity (CGI-IS) Scale. Safety assessments included laboratory, ECG, heart rate, and blood pressure evaluations (at baseline and 8 weeks), as well as a scale completed by the parents to capture side effects at the 8th week.
Results: The total T-DSM-IV-S scores from both the parent and teacher forms decreased significantly in both groups over 8 weeks (p<0.001). No statistically significant differences between the OROS-MPH and IR-MPH groups were found with respect to the mean total score changes on the T-DSM-IV scale of the parent forms at 8 weeks. According to the teacher forms, OROS-MPH was found to be superior to IR-MPH based on the mean total score change from the 4th to the 8th week (p=0.008). OROS-MPH was again found to be superior to IR-MPH when comparing baseline-to-8th-week- and 4th-to-8th-week mean inattention score change son both the teacher (p=0.007 and p=0.025, respectively) and parent (p=0.015 and p=0.013, respectively) forms. With regard to hyperactivity-impulsivity scores, only comparisons of baseline-to-4th-weekscores on the parent forms revealed statistically significant mean score changes (OROS-MPH>IR-MPH, p=0.042). OROS-MPH and IR-MPH were both well tolerated, with similar side-effect profiles.
Conclusion: OROS-MPH was found to be effective and safe in the treatment of ADHD symptoms in Turkish children.