Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder
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DOI：
10.1016/j.jaac.2011.01.007
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发表时间：
2011-04-01
影响因子：
13.3
通讯作者：
Squires, Liza
中科院分区：
文献类型：
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作者：
Findling, Robert L.;Childress, Ann C.;Squires, Liza
目的：比较利地氨苯他明（LDX）与安慰剂对青少年注意力缺陷/多动障碍（ADHD）的疗效和安全性。方法：在为期4周的强制剂量滴定双盲研究中，患有至少中度症状ADHD （ADHD评定量表IV：临床版[ADHD- rs -IV]评分>= 28）的青少年（13至17岁）随机分为安慰剂组或LDX组（30,50或70mg /d）。主要和次要疗效指标为ADHD-RS-IV、临床总体印象改善（CGI-I）和青年生活质量-研究版本（YQOL-R）。安全性评估包括治疗出现的不良事件（teae）、生命体征、实验室结果、体格检查和心电图。结果：总体而言，314名参与者被随机化；309例进行疗效分析，49例退出（11例因teae）。30mg /d、50mg /d和70mg /d LDX组ADHD-RS-IV总分与基线的最小二乘平均值（SE）变化分别为-18.3（1.25）、-21.1（1.28）、-20.7 (1.25)；安慰剂组为12.8 （1.25）
Objective: To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD). Method: Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score >= 28) were randomized to placebo or LDX (30, 50, or 70 mg/d) in a 4-week, forced-dose titration, double-blind study. Primary and secondary efficacy measures were the ADHD-RS-IV, Clinical Global Impressions Improvement (CGI-I), and Youth QOL-Research Version (YQOL-R). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical examinations, and ECG. Results: Overall, 314 participants were randomized; 309 were in efficacy analyses and 49 withdrew (11 due to TEAEs). Least squares mean (SE) change from baseline at endpoint in ADHD-RS-IV total scores were -18.3 (1.25), -21.1 (1.28), -20.7 (1.25) for 30, 50, and 70 mg/d LDX, respectively; 12.8 (1.25) for placebo (p