Objective:

Assess executive function (EF) improvement with SHP465 mixed amphetamine salts (MAS) extended-release in adults with attention-deficit/hyperactivity disorder (ADHD) using responder analyses of the Brown Attention-Deficit Disorder Scale (BADDS).

Methods:

Post hoc analyses examined data from placebo-controlled SHP465 MAS dose-optimization (12.5–75 mg) and fixed-dose (25–75 mg) studies. Treatment response was assessed using two definitions (BADDS total score at endpoint <50 [no EF impairment] vs. ≥50 [impaired]; BADDS total score at endpoint relative to the in-treatment 90% CI range for baseline total score [below the range = improved]).

Results:

Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal p < .0001) in the dose-optimization (BADDS <50: 41.9% vs. 19.2%; below 90% CI range: 57.4% vs. 29.6%) and fixed-dose (BADDS <50: 51.9% vs. 16.7%; below 90% CI range: 70.6% vs. 32.3%) studies.

Conclusion:

Improvement in EF measured by BADDS response rates was approximately 2-fold greater with SHP465 MAS than placebo.

中文翻译：

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用 SHP465 混合安非他明盐缓释剂治疗后诊断为注意力缺陷/多动障碍的成人的执行功能得到改善：通过 2 项随机、安慰剂对照研究进行的事后分析

客观的：

使用布朗注意力缺陷量表 (BADDS) 的响应者分析，评估 SHP465 混合安非他明盐 (MAS) 缓释剂对注意力缺陷/多动障碍 (ADHD) 成人的执行功能 (EF) 改善情况。

方法：

事后分析检查了来自安慰剂对照 SHP465 MAS 剂量优化（12.5-75 mg）和固定剂量（25-75 mg）研究的数据。使用两种定义评估治疗反应（终点的 BADDS 总分 <50 [无 EF 受损] vs. ≥50 [受损]；终点的 BADDS 总分相对于基线总分的治疗中 90% CI 范围 [低于范围=改进]）。

结果：

在剂量优化（BADDS <50：41.9% 对 19.2%；低于 90% CI 范围：57.4% 对 29.6%）中，反应率（SHP465 MAS 与安慰剂）有利于 SHP465 MAS（所有标称p < .0001）和固定剂量（BADDS <50：51.9% 对 16.7%；低于 90% CI 范围：70.6% 对 32.3%）研究。

结论：

用 SHP465 MAS 测量的 BADDS 反应率改善的 EF 比安慰剂高约 2 倍。