PMID- 22088519 OWN - NLM STAT- MEDLINE DCOM- 20120504 LR - 20131121 IS - 2542-5641 (Electronic) IS - 0366-6999 (Linking) VI - 124 IP - 20 DP - 2011 Oct TI - Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder. PG - 3269-74 AB - 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. CONCLUSION: This open-label, naturalistic study provides further evidence of effectiveness and safety of OROS-MPH in school-aged children under routine practice. FAU - Zheng, Yi AU - Zheng Y AD - Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China. doctorzy@yahoo.com FAU - Wang, Yu-Feng AU - Wang YF FAU - Qin, Jiong AU - Qin J FAU - Wang, Li-Wen AU - Wang LW FAU - Zou, Li-Ping AU - Zou LP FAU - Jin, Xing-Ming AU - Jin XM FAU - Xu, Tong AU - Xu T FAU - Wang, Yi AU - Wang Y FAU - Qi, Yuan-Li AU - Qi YL FAU - Gong, Mei-En AU - Gong ME FAU - Yin, Qing-Yun AU - Yin QY FAU - Mai, Jian-Ning AU - Mai JN FAU - Jing, Jin AU - Jing J FAU - Luo, Xiang-Yang AU - Luo XY FAU - Ma, Hong-Wei AU - Ma HW FAU - Li, Hai-Bo AU - Li HB FAU - Xie, Ling AU - Xie L FAU - Li, Yan AU - Li Y FAU - Kuang, Gui-Fang AU - Kuang GF FAU - Yi, Ming-Ji AU - Yi MJ FAU - Wang, Feng AU - Wang F FAU - Zhu, Xiao-Hua AU - Zhu XH FAU - Yao, Yan-Bin AU - Yao YB LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - China TA - Chin Med J (Engl) JT - Chinese medical journal JID - 7513795 RN - 0 (Delayed-Action Preparations) RN - 207ZZ9QZ49 (Methylphenidate) SB - IM MH - Adolescent MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Child MH - Delayed-Action Preparations MH - Female MH - Humans MH - Male MH - Methylphenidate/administration & dosage/adverse effects/*therapeutic use MH - Prospective Studies MH - Treatment Outcome EDAT- 2011/11/18 06:00 MHDA- 2012/05/05 06:00 CRDT- 2011/11/18 06:00 PHST- 2011/11/18 06:00 [entrez] PHST- 2011/11/18 06:00 [pubmed] PHST- 2012/05/05 06:00 [medline] PST - ppublish SO - Chin Med J (Engl). 2011 Oct;124(20):3269-74.