University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH 44106, USA.
J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.
To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD).
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.
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 ≤ .0056 versus placebo for each). Differences in ADHD-RS-IV total scores favored all LDX doses versus placebo at all weeks (p ≤ .0076). On the CGI-I, 69.1% of participants were rated very much/much improved at endpoint with LDX all doses versus placebo (39.5%) (p < .0001). YQOL-R changes at endpoint scores for LDX groups versus placebo were not significant. Commonly reported LDX (all doses combined) TEAEs (≥5%) were decreased appetite, headache, insomnia, decreased weight, and irritability. Small mean increases in pulse and blood pressure and no clinically meaningful trends in ECG changes were noted with LDX.
LDX at all doses was effective versus placebo in treating adolescent ADHD and demonstrated a safety profile consistent with previous LDX studies. CLINICAL TRIALS REGISTRY INFORMATION: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD); http://www.clinicaltrials.gov; NCT00735371.
研究赖氨酸安非他命甲硫酸盐（LDX）在患有注意缺陷多动障碍（ADHD）的青少年中的疗效和安全性。
对至少有中度症状的 ADHD（ADHD 评定量表 IV：临床版[ADHD-RS-IV]得分≥28）的青少年（13 至 17 岁）进行随机分组，接受安慰剂或 LDX（30、50 或 70mg/d）的为期 4 周的强制剂量滴定、双盲研究。主要和次要疗效测量指标是 ADHD-RS-IV、临床总体印象改善（CGI-I）和青少年生活质量研究版（YQOL-R）。安全性评估包括治疗中出现的不良事件（TEAE）、生命体征、实验室检查、体格检查和心电图。
共有 314 名参与者被随机分组；309 名进行了疗效分析，49 名退出（11 名因 TEAEs）。ADHD-RS-IV 总分从基线到终点的最小二乘均值（SE）变化分别为 LDX 30、50 和 70mg/d 组的-18.3（1.25）、-21.1（1.28）、-20.7（1.25）；安慰剂组为-12.8（1.25）（与安慰剂相比，p≤0.0056）。在所有周数（p≤0.0076），ADHD-RS-IV 总分均显示 LDX 各剂量优于安慰剂。在 CGI-I 上，69.1%的参与者在 LDX 所有剂量组中被评为非常好/好得多，而安慰剂组为 39.5%（p<0.0001）。在终点时，LDX 组的 YQOL-R 变化与安慰剂相比没有显著差异。报告的常见 LDX（所有剂量组合）不良事件（≥5%）为食欲减退、头痛、失眠、体重减轻和易怒。LDX 可导致平均脉率和血压略有升高，心电图变化无临床意义的趋势。
LDX 在所有剂量下对治疗青少年 ADHD 均有效，安全性与之前的 LDX 研究一致。
赖氨酸安非他命甲硫酸盐（LDX）在注意缺陷多动障碍（ADHD）青少年中的疗效和安全性；http://www.clinicaltrials.gov；NCT00735371。
