J Korean Acad Child Adolesc Psychiatry.  2010 Jun;21(2):63-71.

The Side Effects and Correlates of OROS-Methylphenidate in the Treatment of Children and Adolescents with ADHD

Affiliations
  • 1Department of Psychiatry, Seoul National University Hospital, Seoul, Korea. kbn1@snu.ac.kr
  • 2Department of Psychiatry, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 3Department of Psychiatry and The Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 4Department of Psychiatry, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Seoul, Korea.
  • 5Department of Psychiatry, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
  • 6Department of Psychiatry, Kwandong University College of Medicine, Myong-Ji Hospital, Goyang, Korea.
  • 7Department of Psychiatry, Seoul National Hospital, Seoul, Korea.
  • 8Department of Child Welfare, Sookmyung Women's University, Seoul, Korea.

Abstract

OBJECTIVES: The aim of this study was to investigate the effect of the clinical and demographic variables such as body weight, dosage, family history of attention-deficit hyperactivity disorder (ADHD), and psychiatric co-morbidity on the side-effects of OROS-Methylphenidate (OROS-MPH), and to evaluate the relationship between drug response and side effect severity.
METHODS
A total of 144 children (ages 6-18) with diagnosed ADHD were treated with OROS-MPH. Children were examined at baseline and after 1, 3, 6, 9, and 12 weeks of each treatment condition. The stimulant drug side effect rating scale (SERS), pulse rate, systolic blood pressure, diastolic blood pressure, and electrocardiogram (ECG) were evaluated to assess side effect profiles. Changes in these parameters from baseline were examined and analyzed.
RESULTS
Anorexia (30.95%) and insomnia (13.10%) were the most commonly reported side effects during this study. Insomnia and loss of appetite score increased at one week follow-up, but was sustained or decreased as treatment progressed. Small but significant increases in pulse rate and diastolic blood pressure were observed during treatment; however, no clinically meaningful changes in ECG parameters were noted during the study. Low body weight, high dosage of OROS-MPH, and family history of ADHD were associated with cardiovascular side effect. In contrast, there was no significant relationship between OROS-MPH treatment response and the severity of side effect and no difference resulted between the responder and non-responder groups with respect to OROS-MPH dosage in the 12 weeks of follow-up.
CONCLUSION
To the best of our knowledge, this study is the first Korean study to investigate comprehensive side effect profiles and their correlates in OROS-MPH treatment for ADHD children. OROS-MPH was well tolerated with no clinically significant side effects during the treatment period. In conclusion, low body weight, high dosage of OROS-MPH, and family history of ADHD could be used as predictive factors in increasing pulse rate and blood pressure.

Keyword

ADHD; OROS-MPH; Side Effects; Drug Response
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