title: Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder.
abstract: BACKGROUND
  Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders during childhood, characterized by the core symptoms of hyperactivity, impulsivity and inattention and puts great burden on children themselves, their families and the society. Osmotic release oral system methylphenidate (OROS-MPH) is a once-daily controlled-release formulation developed to overcome some of the limitations associated with immediate-release methylphenidate (IR-MPH). It has been marketed in China since 2005 but still lacks data from large-sample clinical trials on efficacy and safety profiles. The aim of this study was to evaluate the effectiveness and safety of OROS-MPH in children aged 6 to 16 years with ADHD under naturalistic clinical setting.
  
  
  METHODS
  This 6-week, multi-center, prospective, open-label study enrolled 1447 ADHD children to once-daily OROS-MPH (18 mg, 36 mg or 54 mg) treatment. The effectiveness measures were parent-rated Inattention and Overactivity With Aggression (IOWA) Conners I/O and O/D subscales, physician-rated CGI-I and parent-rated global efficacy assessment scale. Blood pressure, pulse rate measurement, adverse events (AEs) and concomitant medications and treatment review were conducted by the investigator and were served as safety measures.
  
  
  RESULTS
  A total of 1447 children with ADHD (mean age (9.52 ± 2.36) years) were enrolled in this trial. Totally 96.8% children received an OROS-MPH modal dose of 18 mg, 3.1% with 36 mg and 0.1% with 54 mg at the endpoint of study. The parent IOWA Conners I/O score at the end of week 2 showed statistically significant (P < 0.001) improvement with OROS-MPH (mean: 6.95 ± 2.71) versus the score at baseline (10.45 ± 2.72). The change in the parent IOWA Conners O/D subscale, CGI-I and parent-rated global efficacy assessment scale also supported the superior efficacy for OROS-MPH treatment. Fewer than half of 1447 patients (511(35.3%)) reported AEs, and the majority of the events reported were mild (68.2%). No serious adverse events were reported during the study.
  
  
  CONCLUSIONS
  This open-label, naturalistic study provides further evidence of effectiveness and safety of OROS-MPH in school-aged children under routine practice.
authors.affiliation: Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China. doctorzy@yahoo.com
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Yu-Feng
authors.initials: YF
authors.lastname: Wang
authors.forename: Jiong
authors.initials: J
authors.lastname: Qin
authors.forename: Li-Wen
authors.initials: LW
authors.lastname: Wang
authors.forename: Li-Ping
authors.initials: LP
authors.lastname: Zou
authors.forename: Xing-Ming
authors.initials: XM
authors.lastname: Jin
authors.forename: Tong
authors.initials: T
authors.lastname: Xu
authors.forename: Yi
authors.initials: Y
authors.lastname: Wang
authors.forename: Yuan-Li
authors.initials: YL
authors.lastname: Qi
authors.forename: Mei-En
authors.initials: ME
authors.lastname: Gong
authors.forename: Qing-Yun
authors.initials: QY
authors.lastname: Yin
authors.forename: Jian-Ning
authors.initials: JN
authors.lastname: Mai
authors.forename: Jin
authors.initials: J
authors.lastname: Jing
authors.forename: Xiang-Yang
authors.initials: XY
authors.lastname: Luo
authors.forename: Hong-Wei
authors.initials: HW
authors.lastname: Ma
authors.forename: Hai-Bo
authors.initials: HB
authors.lastname: Li
authors.forename: Ling
authors.initials: L
authors.lastname: Xie
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Gui-Fang
authors.initials: GF
authors.lastname: Kuang
authors.forename: Ming-Ji
authors.initials: MJ
authors.lastname: Yi
authors.forename: Feng
authors.initials: F
authors.lastname: Wang
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Zhu
authors.forename: Yan-Bin
authors.initials: YB
authors.lastname: Yao
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D008774:Methylphenidate