Objective:We appraised whether FDA registration trials for ADHD pharmacotherapy in adults provides comparable information to inform treatment expectations.Method:Comparison of ADHD outcome measure patterns in ADHD pharmacotherapy FDA drug label source studies.Results:Among stimulants, from fixed-dose titration data, amphetamine agents had numerically higher placebo-corrected symptom improvement and symptom effect sizes than methylphenidate agents. Symptom effect sizes were lower in the flexible dosing registration studies of atomoxetine and viloxazine. Varying responder definitions were analyzable, based on ≥30% symptom improvement and/or CGI-I improvement of “much” or “very much improved.” Number of exposures needed to create these responses were lower for stimulants than for viloxazine.Conclusion:Heterogeneity in the design and analysis of FDA drug label source trials restricts implications for clinical practice. Research conducted using replicated designs, direct comparison of available treatments, and outcome analyses that generalize to clinical care could better inform clinical decision making.

中文翻译：

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成人多动症药物治疗的比较：来自食品和药物管理局药品标签注册试验结果集中分析的证据

目的：我们评估 ADHD 成人药物治疗的 FDA 注册试验是否提供了可比较的信息，以告知治疗预期。方法：ADHD 药物治疗 FDA 药物标签来源研究中 ADHD 结果测量模式的比较。结果：在兴奋剂中，根据固定剂量滴定数据，与哌醋甲酯药物相比，安非他明药物的安慰剂校正症状改善和症状效应大小在数值上更高。在阿托莫西汀和维洛嗪的灵活剂量登记研究中，症状效应较小。根据症状改善 ≥30% 和/或 CGI-I 改善“很大”或“很大改善”，可以分析不同的应答者定义。兴奋剂产生这些反应所需的暴露次数低于维洛嗪。结论：FDA 药物标签来源试验的设计和分析中的异质性限制了对临床实践的影响。使用重复设计、直接比较现有治疗方法以及推广到临床护理的结果分析进行的研究可以更好地为临床决策提供信息。