Tanaka Yoko, Rohde Luis A, Jin Ling, Feldman Peter D, Upadhyaya Himanshu P
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
J Child Adolesc Psychopharmacol. 2013 May;23(4):262-70. doi: 10.1089/cap.2012.0049.
Atomoxetine has been approved as a treatment for children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in the United States, throughout Europe, and in other countries. This meta-analysis was to assess the consistency of the treatment effect of atomoxetine across four global geographic regions.
Data from 15 acute, double-blind, placebo-controlled trials were pooled (2 in Asia, 4 in Europe, 8 in North America, and 1 in Russia), yielding 2569 pediatric patients with ADHD. Improvements during 6-10 weeks of atomoxetine treatment were evaluated using the ADHD Rating Scale-IV or the Swanson, Nolan, and Pelham Scale-Revised. Consistency across regions was assessed by an interaction test and Higgins I(2). Consistency of one region versus other regions was assessed by effect sizes of individual regions and pairwise differences.
Patient demographics were generally similar across regions. More patients from Asia met diagnostic criteria for ADHD inattentive subtype and fewer for combined subtype compared with patients from Europe, North America, or Russia. Asian patients had a lower mean baseline ADHD total score and mean hyperactivity/impulsivity subscore. Treatment effects showed marginal inconsistency and moderate heterogeneity among the regions (percentage of patients achieving a 40% decrease from baseline ADHD scores, atomoxetine versus placebo: Asia 39.6%, 24.0%; Europe 40.2%, 12.1%; North America 45.3%, 21.7%; Russia 54.2%, 33.3%). Inconsistency was observed primarily in Asia versus the other regions. Completion rates with atomoxetine were higher in Asia and Russia (94.4% and 94.3%, respectively) than in Europe (84.3%) or North America (80.4%).
Atomoxetine was demonstrated as an effective treatment for ADHD in 15 clinical trials from four global regions. The current meta-analysis has revealed a degree of heterogeneity in treatment efficacy across regions, most notably in the comparison of Asian patients relative to those from the other regions.
在美国、整个欧洲及其他国家，托莫西汀已被批准用于治疗儿童和青少年注意力缺陷多动障碍（ADHD）。本荟萃分析旨在评估托莫西汀在四个全球地理区域治疗效果的一致性。
汇总了15项急性、双盲、安慰剂对照试验的数据（亚洲2项、欧洲4项、北美8项、俄罗斯1项），纳入了2569例患有ADHD的儿科患者。使用ADHD评定量表-IV或修订版的斯旺森、诺兰和佩勒姆量表评估托莫西汀治疗6 - 10周期间的改善情况。通过交互检验和希金斯I²评估各区域间的一致性。通过各区域的效应量和两两差异评估一个区域与其他区域的一致性。
各区域患者的人口统计学特征总体相似。与欧洲、北美或俄罗斯的患者相比，亚洲更多患者符合ADHD注意力不集中亚型的诊断标准，符合混合型亚型的患者较少。亚洲患者的平均基线ADHD总分及平均多动/冲动子分数较低。各区域间治疗效果显示出轻微的不一致性和中度异质性（从基线ADHD评分降低40%的患者百分比，托莫西汀组与安慰剂组相比：亚洲39.6%，24.0%；欧洲40.2%，12.1%；北美45.3%，21.7%；俄罗斯54.2%，33.3%）。主要在亚洲与其他区域之间观察到不一致性。托莫西汀的完成率在亚洲和俄罗斯较高（分别为94.4%和94.3%），高于欧洲（84.3%）或北美（80.4%）。
在来自四个全球区域的15项临床试验中，托莫西汀被证明是治疗ADHD的有效药物。当前的荟萃分析揭示了各区域治疗效果存在一定程度的异质性，最显著的是亚洲患者与其他区域患者的比较。
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