DOI QR코드

DOI QR Code

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

ADHD 환자에 대한 OROS-Methylphenidate 약물치료의 부작용과 관련요인들에 대한 연구

  • Kim, Jin-Sun (Department of Psychiatry, Seoul National University Hospital) ;
  • Kim, Bung-Nyun (Department of Psychiatry, Seoul National University Hospital) ;
  • Cho, Soo-Churl (Department of Psychiatry, Seoul National University Hospital) ;
  • Shin, Min-Sup (Department of Psychiatry, Seoul National University Hospital) ;
  • Yoo, Hee-Jeong (Department of Psychiatry, Seoul National University Bundang Hospital) ;
  • Kim, Jae-Won (Department of Psychiatry, Seoul National University Hospital) ;
  • Song, Dong-Ho (Department of Psychiatry and The Institute of Behavioral Science in Medicine, Yonsei University College of Medicine) ;
  • Shin, Dong-Won (Department of Psychiatry, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospita) ;
  • Joung, Yoo-Sook (Department of Psychiatry, Sungkyunkwan University School of Medicine, Samsung Medical Center) ;
  • Cheon, Keun-Ah (Department of Psychiatry, Kwandong University College of Medicine, Myong-Ji Hospital) ;
  • Shin, Yee-Jin (Department of Psychiatry and The Institute of Behavioral Science in Medicine, Yonsei University College of Medicine) ;
  • Kim, Ye-Ni (Department of Psychiatry, Seoul National Hospital) ;
  • Ha, Eun-Hye (Department of Child Welfare, Sookmyung Women's University)
  • 김진선 (서울대학교병원 신경정신과) ;
  • 김붕년 (서울대학교병원 신경정신과) ;
  • 조수철 (서울대학교병원 신경정신과) ;
  • 신민섭 (서울대학교병원 신경정신과) ;
  • 유희정 (분당서울대학교병원 신경정신과) ;
  • 김재원 (서울대학교병원 신경정신과) ;
  • 송동호 (연세대학교병원 신경정신과 행동과학연구소) ;
  • 신동원 (성균관대학교 의과대학 강북삼성병원 신경정신과학교실) ;
  • 정유숙 (성균관대학교 의과대학 서울삼성병원 신경정신과학교실) ;
  • 천근아 (관동대학교 의과대학 명지병원 신경정신과학교실) ;
  • 신의진 (연세대학교병원 신경정신과 행동과학연구소) ;
  • 김예니 (국립서울병원 신경정신과) ;
  • 하은혜 (숙명여자대학교 아동복지학과)
  • Received : 2010.02.01
  • Accepted : 2010.04.29
  • Published : 2010.06.30

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 OROSMPH, and family history of ADHD could be used as predictive factors in increasing pulse rate and blood pressure.

Keywords

References

  1. Elia J. Drug treatment for hyperactive children. Therapeutic guidelines. Drugs 1993;46:863-871. https://doi.org/10.2165/00003495-199346050-00006
  2. Anon. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41:26-49. https://doi.org/10.1097/00004583-200202001-00003
  3. Wilens T, Pelham W, Stein M, Conners CK, Abikoff H, Atkins M, et al. ADHD treatment with once-daily OROS methylphenidate: interim 12-month results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry 2003;42:424-433. https://doi.org/10.1097/01.CHI.0000046814.95464.7D
  4. Kelly KL, Rapport MD, Dupaul GJ. Attention deficit disorder and methylphenidate-a multi-step analysis of dose-response effects on childrens cardiovascular functioning. Int Clin Psychopharmacol 1988;3:167-181. https://doi.org/10.1097/00004850-198804000-00007
  5. Solanto MV, Conners CK. A dose-response and time-action analysis of autonomic and behavioral-effects of methylphenidate in attention deficit disorder with hyperactivity. Psychophysiology 1982;19:658-667. https://doi.org/10.1111/j.1469-8986.1982.tb02519.x
  6. Tannock R, Schachar RJ, Carr RP, Logan GD. Dose-response effects of methylphenidate on academic-performance and overt behavior in hyperactive-children. Pediatrics 1989;84: 648-657.
  7. Ahmann PA, Waltonen SJ, Olson KA, Theye FW, Vanerem AJ, Laplant RJ. Placebo-controlled evaluation of ritalin side-effects. Pediatrics 1993;91:1101-1106.
  8. Barkley RA, Mcmurray MB, Edelbrock CS, Robbins K. Sideeffects of methylphenidate in children with attention-deficit hyperactivity disorder-a systemic, placebo-controlled evaluation. Pediatrics 1990;86:184-192.
  9. Klein R, Bessler A. Stimulant side effects in children. In: Lieberman J, ed. Adverse Effects of Psychotropic Drugs. New York: Guilford Press;1992. p.470-496.
  10. Firestone P, Musten LM, Pisterman S, Mercer J, Bennett S. Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: A double-blind placebo-controlled study. J Child Adolesc Psychopharmacol 1998;8:13-25. https://doi.org/10.1089/cap.1998.8.13
  11. Stein MA, Sarampote CS, Waldman ID, Robb AS, Conlon C, Pearl PL, et al. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics 2003;112:404-413. https://doi.org/10.1542/peds.112.5.e404
  12. Diamond IR, Tannock R, Schachar RJ. Response to methylphenidate in children with ADHD and comorbid anxiety. J Am Acad Child Adolesc Psychiatry 1999;38:402-409. https://doi.org/10.1097/00004583-199904000-00012
  13. Karabekiroglu K, Yazgan YM, Dedeoglu C. Can we predict short-term side effects of methylphenidate immediate-release? Int J Psychiaty Clin 2008;12:48-54. https://doi.org/10.1080/13651500701435954
  14. Cho SC, Shin MS. Diagnosis and assessment of child psychopathology. Seoul: Hakjisa;2006.
  15. Steele M, Jensen PS, Quinn DMP. Remission versus response as the goal of therapy in ADHD: A new standard for the field? Clin Ther 2006;28:1892-1908. https://doi.org/10.1016/j.clinthera.2006.11.006
  16. Kovacs M, Beck AT. An empirical- clinical approach toward a definition of childhood depression. depression in childhood: diagnosis', treatment and conceptual models. New York: Raven Press; 1977.
  17. Spielberger C. Preliminary manual for the Stait-Trait Anxiety Inventory for Children. Palo Alto: Consulting Psychologist Press; 1973.
  18. Cho SC, Choi JS. Development of the Korean Form of the State- Trait Anxiety Inventory for Children. Seoul J Psychiatry 1989;14: 150-157.
  19. Cho SC. A multi-center, open label study to evaluate safe and effective doses of OROS-MPH. Spring Meeting of the Korea Academy of Child and Adolescent Psychitry; 2004 May 14-15; Gyeongju, Korea. Seoul: Korea Academy of Child and Adolescent Psychietry;2004.
  20. Stein MA, Blondis TA, Schnitzler ER, OBrien T, Fishkin J, Blackwell B, et al. Methylphenidate dosing: twice daily versus three times daily. Pediatrics 1996;98:748-756.
  21. Rapport MD, Moffitt C. Attention deficit/hyperactivity disorder and methylphenidate - a review of height/weight, cardiovascular, and somatic complaint side effects. Clin Psychol Rev 2002;22: 1107-1131. https://doi.org/10.1016/S0272-7358(02)00129-0
  22. Fine S, Johnston C. Drug and placebo side-effects in methylphenidate- placebo trial for attention-deficit hyperactivity disorder. Child Psychiatry Hum Dev 1993;24:25-30. https://doi.org/10.1007/BF02353715
  23. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-III. Washington DC: American Psychiatric Association;1980.
  24. Efron D, Jarman F, Barker M. Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. Pediatrics 1997;100: 662-666. https://doi.org/10.1542/peds.100.4.662
  25. Ring A, Stein D, Barak Y, Teicher A, Hadjez J, Elizur A, et al. Sleep disturbances in children with attention-deficit/hyperactivity disorder: A comparative study with healthy siblings. J Learn Disabil 1998;31:572-578. https://doi.org/10.1177/002221949803100607
  26. Solanto MV. Neuropsychopharmacological mechanisms of stimulant drug action in attention-deficit hyperactivity disorder: a review and integration. Behav Brain Res 1998;94:127-152. https://doi.org/10.1016/S0166-4328(97)00175-7
  27. Findling RL, Short EJ, Manos MJ. Short-term cardiovascular effects of methylphenidate and Adderall. J Am Acad Child Adolesc Psychiatry 2001;40:525-529. https://doi.org/10.1097/00004583-200105000-00011
  28. Brown RT, Sexson SB. Effects of methylphenidate on cardiovascular- responses in attention deficit hyperactivity disordered adolescents. J Adolesc Health 1989;10:179-183. https://doi.org/10.1016/0197-0070(89)90229-5
  29. Brown RT, Wynne ME, Slimmer LW. Attention deficit disorder and the effect of methylphenidate on attention, behavioral, and cardiovascular functioning. J Clin Psychiatry 1984;45:473-476.
  30. Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry 2005;44:1015-1023. https://doi.org/10.1097/01.chi.0000173291.28688.e7
  31. Steele M, Weiss M, Swanson J, Wang J, Prinzo RS, Binder CE. 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 2006;13:50-62.

Cited by

  1. The Current State of Clinical Studies for Herbal Medicine of Attention Deficit Hyperactivity Disorder (ADHD) -Focusing on Chinese Journals- vol.24, pp.1, 2013, https://doi.org/10.7231/jon.2013.24.1.001
  2. A Brief Replication Study Comparing Stimulants and Non-Stimulants for Attention-Deficit/Hyperactivity Disorder Treatment with a Focus on the Compliance, Efficacy, and Satisfaction vol.32, pp.1, 2010, https://doi.org/10.5765/jkacap.200024