Treatment Adherence of Osmotic-Controlled Release Oral Delivery System Methylphenidate in Korean Children and Adolescents with Attention-Deficit Hyperactivity Disorder

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the treatment duration and adherence of osmotic-controlled release oral delivery system (OROS) methylphenidate for treatment of attention-deficit hyperactivity disorder (ADHD). METHODS: A total of 843 children with ADHD were recruited 213 children (25.3%) who had previously taken medications for ADHD and 630 drug-naive children (74.7%) were recruited. The dosage was adjusted according to the clinician's judgment. The primary efficacy endpoint of this study was treatment retention rate, which was estimated at Week 12 and Week 20 using the Kaplan-Meier curve. The Swanson, Nolan and Pelham-IV (SNAP-IV), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement, and the side effect rating scale were measured at every visit. Remission rates were presented based on SNAP-IV and CGI-S, respectively. RESULTS: The treatment retention rate at 12 weeks and at 20 weeks was 76.2% and 66.8%, respectively. Divided according to 6-8, 9-11, 12-14 and 15-18 years of age, younger children tended to show a statistically higher treatment retention rate (p=.02). Based on SNAP-IV and CGI scores, children with better response to medication showed tendencies of statistically higher treatment retention rate. The most common adverse events included loss of appetite (7.1%) and insomnia (3.3%). There was no serious adverse event related to the treatment, such as death. CONCLUSION: The use of OROS methylphenidate for treatment of ADHD was safe and tolerable for children. In this study, lower age and better treatment response showed a statistically significant relationship with higher treatment adherence. Boys showed a trend of high treatment adherence. The treatment adherence at 20 weeks was satisfactory, however, the treatment adherence after 20 weeks showed a sharp decrease. Therefore, treatment persistence for six months after the beginning of ADHD treatment is important. In addition, the positive role of psycho-education for children and parents is necessary for increasing treatment adherence.