Tags

Type your tag names separated by a space and hit enter

Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder.
Chin Med J (Engl). 2011 Oct; 124(20):3269-74.CM

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.

CONCLUSION

This open-label, naturalistic study provides further evidence of effectiveness and safety of OROS-MPH in school-aged children under routine practice.

Authors+Show Affiliations

Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China. doctorzy@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22088519

Citation

Zheng, Yi, et al. "Prospective, Naturalistic Study of Open-label OROS Methylphenidate Treatment in Chinese School-aged Children With Attention-deficit/hyperactivity Disorder." Chinese Medical Journal, vol. 124, no. 20, 2011, pp. 3269-74.
Zheng Y, Wang YF, Qin J, et al. Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder. Chin Med J (Engl). 2011;124(20):3269-74.
Zheng, Y., Wang, Y. F., Qin, J., Wang, L. W., Zou, L. P., Jin, X. M., Xu, T., Wang, Y., Qi, Y. L., Gong, M. E., Yin, Q. Y., Mai, J. N., Jing, J., Luo, X. Y., Ma, H. W., Li, H. B., Xie, L., Li, Y., Kuang, G. F., ... Yao, Y. B. (2011). Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder. Chinese Medical Journal, 124(20), 3269-74.
Zheng Y, et al. Prospective, Naturalistic Study of Open-label OROS Methylphenidate Treatment in Chinese School-aged Children With Attention-deficit/hyperactivity Disorder. Chin Med J (Engl). 2011;124(20):3269-74. PubMed PMID: 22088519.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder. AU - Zheng,Yi, AU - Wang,Yu-Feng, AU - Qin,Jiong, AU - Wang,Li-Wen, AU - Zou,Li-Ping, AU - Jin,Xing-Ming, AU - Xu,Tong, AU - Wang,Yi, AU - Qi,Yuan-Li, AU - Gong,Mei-En, AU - Yin,Qing-Yun, AU - Mai,Jian-Ning, AU - Jing,Jin, AU - Luo,Xiang-Yang, AU - Ma,Hong-Wei, AU - Li,Hai-Bo, AU - Xie,Ling, AU - Li,Yan, AU - Kuang,Gui-Fang, AU - Yi,Ming-Ji, AU - Wang,Feng, AU - Zhu,Xiao-Hua, AU - Yao,Yan-Bin, PY - 2011/11/18/entrez PY - 2011/11/18/pubmed PY - 2012/5/5/medline SP - 3269 EP - 74 JF - Chinese medical journal JO - Chin Med J (Engl) VL - 124 IS - 20 N2 - 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. SN - 2542-5641 UR - https://www.unboundmedicine.com/medline/citation/22088519/Prospective_naturalistic_study_of_open_label_OROS_methylphenidate_treatment_in_Chinese_school_aged_children_with_attention_deficit/hyperactivity_disorder_ L2 - https://Insights.ovid.com/pubmed?pmid=22088519 DB - PRIME DP - Unbound Medicine ER -