|Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial|
|Wang, Yufeng; Zheng, Yi; Du, Yasong; Song, Dong H.; Shin, Yee-Jin; Cho, Soo C.; Kim, Bung N.; Ahn, Dong H.; Marquez-Caraveo, Maria E.; Gao, Haitao; Williams, David W.; Levine, Louise R.|
|关键词||atomoxetine attention deficit hyperactivity disorder methylphenidate|
|刊名||AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY|
|收录类别||SCI ; SSCI|
|WOS标题词||Science & Technology|
|关键词[WOS]||ONCE-DAILY ATOMOXETINE ; OPEN-LABEL TRIAL ; DEFICIT/HYPERACTIVITY DISORDER ; TREATMENT STRATEGIES ; CHILDREN ; ADHD ; PLACEBO ; ADOLESCENTS ; EFFICACY ; PHARMACOTHERAPY|
Objective: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs.
Method: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January-October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8-1.8 mg kg(-1) day(-1); n = 164) or twice-daily methylphenidate (0.2-0.6 mg kg(-1) day(-1); n = 166) for similar to 8 weeks. Primary efficacy assessment was the comparison of response rates (>= 40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight.
Results: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = -11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p < 0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than m ethylphenidate-treated patients (- 1.2 kg vs. -0.4 kg; p < 0.001).
Conclusions: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.
|作者单位||1.Beijing Med Univ, Inst Mental Hlth, Beijing, Peoples R China|
2.Beijing An Ding Hosp, Beijing, Peoples R China
3.Shanghai Mental Hlth Ctr, Shanghai, Peoples R China
4.Eli Lilly & Co, Lilly Corp Ctr, Neurosci Prod, Indianapolis, IN 46285 USA
|Wang, Yufeng,Zheng, Yi,Du, Yasong,et al. Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial[J]. AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY,2007,41(3):222-230.|
|APA||Wang, Yufeng.,Zheng, Yi.,Du, Yasong.,Song, Dong H..,Shin, Yee-Jin.,...&Levine, Louise R..(2007).Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY,41(3),222-230.|
|MLA||Wang, Yufeng,et al."Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial".AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY 41.3(2007):222-230.|