Switching from Methylphenidate-Immediate Release (MPH-IR) to Methylphenidate- OROS (OROS-MPH): A Multi-center, Open-label Study in Korea
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Objective: The objective of this study was to evaluate the efficacy and safety of methylphenidate HCL OROS extended-release (OROS-MPH) among children with attention deficit hyperactivity disorder (ADHD) who had been previously treated with methylphenidate HCL immediate-release (MPH-IR). Methods: The sample included 102 children aged 6-12 (9.4±2.6) years who had been diagnosed with ADHD according the criteria of the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV; American Psychiatric Association,1994) and who were attending seven centers in Korea. All participants had been medicated with a stable dose of MPH (10-60mg/day) for at least 3 weeks before entry into the study. Doses of OROS-MPH were comparable to daily doses of MPH. Efficacy was assessed at baseline (day 0) and at day 28 with the Inattentive-Overactive with Aggression (IOWA) Conners Rating Scale,which was completed by parents/caregivers and teachers, the Peer Interaction Rating Items, which were completed by teachers,and the Clinical Global Impression (CGI) scale, which was completed by child psychiatrists. Paired t-tests were used, and P-values were set at the 0.05 level. Results: Of the subjects, 92.2% were boys and 79.4% were students in the first to fourth grades of elementary school. 72%were diagnosed with the combined type of ADHD, 23% were diagnosed with the inattentive type, and 5% were diagnosed with the hyperactive-impulsive type. The results of the parents’ responses to the Inattention/Hyperactivity (I/H) and Oppositional/Defiant (O/D) subscales of the IOWA Conners scale indicated statistically significant improvement in childrens behavior after 4 weeks of treatment with OROS-MPH (t=6.28, p＜.001, t=4.12, p＜.001). However, the teachers’ responses to the Conners I/H and O/D subscales indicated no significant improvement at 4 weeks. The teachers also reported no significant improvements under the OROS-MPH compared with the MPH-IR condition with respect to peer interactions. Scores on the CGI scale showed that 46.1% of children with ADHD were rated by psychiatrists as “minimally improved”, 27.5% as “much improved,”1.0% as “very much improved,” 3.9% as “minimally worse,” and 16.7% as showing “no change”. Children exhibited significantly fewer tics with OROS-MPH treatment than with MPH-IR treatment (19.6% vs. 27.7%). We found no differences between in sleep and appetite problems according to medication. Conclusion: The results of this study indicated that an MPH-IR regimen can be successfully changed to a once-daily OROS-MPH regimen without any serious adverse effects. The changes in parent/caregiver IOWA Conners ratings suggested that OROSMPH improved the control of symptoms after school, a finding that is consistent with the 12-h duration of action of this medication. Because the therapeutic effect of OROS-MPH is sufficiently longer than that of a b.i.d. dose of MPH-IR, OROS-MPH had significant positive effects on oppositional/defiant behavior in addition to its effects on the core symptoms of ADHD.
Abstract
Objective: The objective of this study was to evaluate the efficacy and safety of methylphenidate HCL OROS extended-release (OROS-MPH) among children with attention deficit hyperactivity disorder (ADHD) who had been previously treated with methylphenidate HCL immediate-release (MPH-IR). Methods: The sample included 102 children aged 6-12 (9.4±2.6) years who had been diagnosed with ADHD according the criteria of the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV; American Psychiatric Association,1994) and who were attending seven centers in Korea. All participants had been medicated with a stable dose of MPH (10-60mg/day) for at least 3 weeks before entry into the study. Doses of OROS-MPH were comparable to daily doses of MPH. Efficacy was assessed at baseline (day 0) and at day 28 with the Inattentive-Overactive with Aggression (IOWA) Conners Rating Scale,which was completed by parents/caregivers and teachers, the Peer Interaction Rating Items, which were completed by teachers,and the Clinical Global Impression (CGI) scale, which was completed by child psychiatrists. Paired t-tests were used, and P-values were set at the 0.05 level. Results: Of the subjects, 92.2% were boys and 79.4% were students in the first to fourth grades of elementary school. 72%were diagnosed with the combined type of ADHD, 23% were diagnosed with the inattentive type, and 5% were diagnosed with the hyperactive-impulsive type. The results of the parents’ responses to the Inattention/Hyperactivity (I/H) and Oppositional/Defiant (O/D) subscales of the IOWA Conners scale indicated statistically significant improvement in childrens behavior after 4 weeks of treatment with OROS-MPH (t=6.28, p＜.001, t=4.12, p＜.001). However, the teachers’ responses to the Conners I/H and O/D subscales indicated no significant improvement at 4 weeks. The teachers also reported no significant improvements under the OROS-MPH compared with the MPH-IR condition with respect to peer interactions. Scores on the CGI scale showed that 46.1% of children with ADHD were rated by psychiatrists as “minimally improved”, 27.5% as “much improved,”1.0% as “very much improved,” 3.9% as “minimally worse,” and 16.7% as showing “no change”. Children exhibited significantly fewer tics with OROS-MPH treatment than with MPH-IR treatment (19.6% vs. 27.7%). We found no differences between in sleep and appetite problems according to medication. Conclusion: The results of this study indicated that an MPH-IR regimen can be successfully changed to a once-daily OROS-MPH regimen without any serious adverse effects. The changes in parent/caregiver IOWA Conners ratings suggested that OROSMPH improved the control of symptoms after school, a finding that is consistent with the 12-h duration of action of this medication. Because the therapeutic effect of OROS-MPH is sufficiently longer than that of a b.i.d. dose of MPH-IR, OROS-MPH had significant positive effects on oppositional/defiant behavior in addition to its effects on the core symptoms of ADHD.
참고문헌 (21)
- Canino G, "The DSM-IV rates of child and adolescent disorders in Puerto Rico: prevalence, correlates, service use, and the effects of impairment", Arch Gen Psychiatry, 61, pp.85~93 (2004)
- Ford T, "The British Child and Adolescent Mental Health Survey 1999: the prevalence of DSM-IV disorders", J Am Acad Child Adolesc Psychiatry, 42, pp.1203~1211 (2003)
- Brown RT, "Prevalence and assessment of attention- deficit", hyperactivity disorder in primary care settings, 2001, pp.107, E43~
- Cho SC, "Prevalence of disruptive behavior disor-ders", J Korean Acad Child Adolesc Psychiatry, 5, pp.141~149 (1994)
- Kim BN, "Community based study for characteristics of children with subthreshold attention deficit hyperactivity disorder", J Korean Neuropsychiatric Association, 41, pp.110~122 (2002)
- American Psychiatric Association, "Diagnostic and statistical manual of mental disorders. 4th ed" (1994), American psychiatric Association
- Goldman LS, "Diagnosis and treatment of attention-deficit", hyperactivity disorder in children and adolescents. Council on Scientific Affairs, American Medical Association, 1998, pp.279, 1100~1107
- Steele M, "A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder", Can J Clin Pharmacol, 13, pp.50~62 (2006)
- 김붕년, "주의력결핍 과잉행동장애 한국형 치료 권고안 (IV)", 소아 청소년 정신의학, 18(1), pp.26~30 (2007), 대한소아청소년 정신의학회
- Hwang JW, "Compliance study of methylph-enidate in the treatment of ADHD", J Korean Acad Child Adolesc Psychiatry, 15, pp.160~167 (2004)
- Hinshaw SP, "Peer relationships in children with attention-deficit hyperactivity disorder with and without comorbid aggression", Dev Psychopathol, 7, pp.627~647 (1995)
- Schachar RJ, "Behavioral, situational, and temporal effects of treatment of ADHD with methylphenidate", J Am Acad Child Adolesc Psychiatry, 36, pp.754~763 (1997)
- Remschmidt H, "Symptom control in children and adolescents with attention-deficit", hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study, 2005, pp.14, 297~304
- Hoare P, "12-month efficacy and safety of OROS MPH in children and adolescents with attention-deficit", hyperactivity disorder switched from MPH, 2005, pp.14, 305~309
- Barkley RA, "The effects of methylphenidate on the mother-child interactions of hyperactive children", Arch Gen Psychiatry, 36, pp.201~208 (1979)
- Barkley RA, "Effects of age and Ritalin dosage on the mother-child interactions of hyperactive children", J Consult Clin Psychol, 52, pp.750~758 (1984)
- Pelham WE, "Methylphenidate and children with attention deficit disorder. Dose effects on classroom academic and social behavior", Arch Gen Psychiatry, 42, pp.948~952 (1985)
- Pelham WE Jr, "Methylphenidate and baseball playing in ADHD children: who's on first", J Consult Clin Psychol, 58, pp.130~133 (1990)
- MTA Cooperative Group, "A 14-month randomized clinical trial of treatment strategies for attention-deficit", hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD, 1999, pp.56, 1073~1086
- Pelham WE, "Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings", Pediatrics, 107, pp.E105~ (2001)
- Swanson J, "Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit", hyperactivity disorder: proof-of-concept and proof-of-product studies, 2003, pp.60, 204~211