Keck School of Medicine of the University of Southern California, Los Angeles, and Brown Clinic for Attention & Related Disorders, Manhattan Beach, CA, USA.
Takeda Pharmaceuticals, Lexington, MA, USA.
J Atten Disord. 2022 Jan;26(2):256-266. doi: 10.1177/1087054720961819. Epub 2020 Nov 5.
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).
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]).
Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal < .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.
Improvement in EF measured by BADDS response rates was approximately 2-fold greater with SHP465 MAS than placebo.
使用布朗注意缺陷障碍量表（BADDS）应答分析评估 SHP465 混合安非他命盐（MAS）缓释剂在注意缺陷多动障碍（ADHD）成人患者中的执行功能（EF）改善情况。
事后分析检查了安慰剂对照 SHP465 MAS 剂量优化（12.5-75mg）和固定剂量（25-75mg）研究的数据。采用两种定义评估治疗应答（终点时 BADDS 总分<50[无 EF 损伤]与≥50[损伤]；终点时 BADDS 总分相对于基线总分的治疗内 90%CI 范围[低于范围=改善]）。
在剂量优化（BADDS<50：41.9%比 19.2%；低于 90%CI 范围：57.4%比 29.6%）和固定剂量（BADDS<50：51.9%比 16.7%；低于 90%CI 范围：70.6%比 32.3%）研究中，SHP465 MAS 的应答率（SHP465 MAS 比安慰剂）均优于 SHP465 MAS（所有名义 P<0.0001）。
通过 BADDS 应答率衡量的 EF 改善，SHP465 MAS 比安慰剂大约高出 2 倍。
