European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
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DOI：
10.1016/j.euroneuro.2012.11.012
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发表时间：
2013-10-01
影响因子：
5.6
通讯作者：
Squires, Liza
中科院分区：
文献类型：
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作者：
Coghill, David;Banaschewski, Tobias;Squires, Liza
本研究评价了二甲磺酸利右苯丙胺（LDX）与安慰剂相比在欧洲儿童和青少年注意力缺陷多动障碍（ADHD）中的疗效和安全性。基线ADHD评定量表第四版（ADHD-RS-1V）总分≥ 28分的患者（6-17岁）随机（1：1：1）接受剂量优化的LDX（30、50或70 mg/天）、OROS-MPH（18、36或54 mg/天）或安慰剂治疗7周。主要和关键次要疗效指标分别为运动员评定的ADHD-RS-IV和临床总体印象改善（CGI-1）评分。安全性评估包括治疗后出现的不良事件（TEAE）、心电图和生命体征。在336例随机化患者中，196例完成了研究。LDX和安慰剂之间ADHD-RS-IV总分从基线到终点的最小二乘平均变化差异为18.6（95%置信区间[CI]：-21.5至15.7）（p
This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-1V) total score >= 28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70 mg/day), OROS-MPH (18, 36, or 54 mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-1) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was 18.6 (95% confidence interval [CI]: -21.5 to 15.7) (p