不良事件模式能否为多动症治疗的共同决策提供依据?对FDA批准的成人治疗方法注册试验证据的系统性回顾。

IF 1.3 4区 医学 Q3 PSYCHIATRY Journal of Psychiatric Practice Pub Date : 2024-05-01 DOI:10.1097/PRA.0000000000000784
Joseph B Bond, Daniel M Walsh, Craig B H Surman
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引用次数: 0

摘要

导言:成年患者和临床医生在治疗注意力缺陷/多动障碍(ADHD)时面临多种药物选择。如果这些方案之间的不良反应类型或发生率存在差异,那么这些差异可以为共同决策过程提供参考:为了辨别基于证据的不同风险模式,我们分析了美国食品及药物管理局(FDA)批准用于治疗成人注意力缺陷多动障碍(ADHD)的药物包装标签数据,以及用于创建这些标签的注册试验报告。我们对不良反应进行了三项分析:安慰剂校正后的不良反应发生率(每 5、10 和 20 名参与者中各占 1 例)、不良反应与停药的关联性以及不良反应在治疗方案中的独特性:结果:在已获准治疗成人多动症的 7 种药物中,在固定剂量和灵活剂量的混合研究中,非兴奋剂类药物的副作用种类最多,但兴奋剂类药物的副作用发生率较高。所有药物出现不良反应的最低频率为每 10 名参与者中出现 1 例。兴奋剂药物之间以及兴奋剂与非兴奋剂之间的总体停药率没有差异:据我们所知,这是第一项对美国食品及药物管理局批准用于治疗成人多动症的所有药物注册试验数据进行汇编和比较的研究。本文描述了一个过程,通过该过程,可将现成的不良事件报告数据作为一种工具,为共同的临床决策提供信息。虽然所纳入的试验在方法和结果报告方面的差异可能会限制其普遍性,但所纳入的单个患者数量和停药数据的完整性可为与患者讨论不良经历的相对可能性及其他患者关注的问题提供参考。
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Can Adverse Event Patterns Inform Shared Decision-Making in ADHD Treatment? A Systematic Review of Evidence From Registration Trials for FDA-Approved Treatments in Adults.

Introduction: Adult patients and clinicians are faced with several pharmacological options to manage attention-deficit/hyperactivity disorder (ADHD). If types or rates of adverse experiences vary among these options, these differences could inform the shared decision-making process.

Methods: To discern differentiating evidence-based patterns of risk, we analyzed data from FDA package labels for drugs approved to treat adult ADHD and reports from the registration trials used to create these labels. Three analyses of adverse effects were conducted: placebo-corrected occurrence at rates of 1 in 5, 10, and 20 participants, association with discontinuation, and uniqueness of occurrence within the treatment options.

Results: Among the 7 agents approved to treat adult ADHD, the number of types of side effects experienced during a mix of fixed and flexible-dose studies was greatest among the nonstimulant medications, but the stimulant medications had higher rates of occurrence of side effects. The minimum frequency at which all medications had adverse events was 1 in 10 participants. Overall discontinuation rates did not differ among the stimulant medications nor between stimulants and nonstimulants.

Discussion: To our knowledge, this is the first study to compile and compare data from all FDA registration trials for medications approved to treat adult ADHD. This article describes a process by which readily available adverse event reporting data can be used as a tool to inform shared clinical decision-making. While differences in the methodology and outcome reporting of the trials included may limit generalizability, the number of individual patients included and the completeness of the discontinuation data can be used to inform discussions with patients about the relative likelihood of adverse experiences and other patient concerns.

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来源期刊
CiteScore
2.30
自引率
10.50%
发文量
159
审稿时长
>12 weeks
期刊介绍: Journal of Psychiatric Practice® seizes the day with its emphasis on the three Rs — readability, reliability, and relevance. Featuring an eye-catching style, the journal combines clinically applicable reviews, case studies, and articles on treatment advances with practical and informative tips for treating patients. Mental health professionals will want access to this review journal — for sharpening their clinical skills, discovering the best in treatment, and navigating this rapidly changing field. Journal of Psychiatric Practice combines clinically applicable reviews, case studies, and articles on treatment advances with informative "how to" tips for surviving in a managed care environment.
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