Abstract：
BACKGROUND: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：成人患者和临床医生面临着几种治疗注意力缺陷/多动障碍（ADHD）的药物选择。如果不良经历的类型或比率在这些选项中有所不同，这些差异可以为共同的决策过程提供信息。
方法：为了区分基于证据的风险模式，我们分析了FDA包装标签中批准用于治疗成人ADHD的药物的数据,以及用于创建这些标签的注册试验的报告.对不良反应进行了三项分析：安慰剂校正发生率为5、10和20名参与者中的1名，与停药有关，以及治疗方案中发生的唯一性。
结果：在批准治疗成人多动症的7种药物中，在非兴奋剂药物中，在固定和灵活剂量研究的混合过程中经历的副作用类型的数量是最大的，但是兴奋剂药物的副作用发生率更高。所有药物发生不良事件的最小频率为10名参与者中的1名。兴奋剂药物之间，兴奋剂和非兴奋剂之间的总体停药率没有差异。
结论：据我们所知，本研究是首次对所有FDA注册试验的批准用于治疗成人多动症的药物数据进行汇总和比较的研究.本文描述了一个过程，通过该过程，可以将现成的不良事件报告数据用作告知共享临床决策的工具。虽然所包括的试验的方法和结果报告的差异可能会限制普遍性，纳入的个体患者数量和停药数据的完整性可用于与患者讨论不良经历和其他患者担忧的相对可能性.
方法：为了区分基于证据的风险模式，我们分析了FDA包装标签中批准用于治疗成人ADHD的药物的数据,以及用于创建这些标签的注册试验的报告.对不良反应进行了三项分析：安慰剂校正发生率为5、10和20名参与者中的1名，与停药有关，以及治疗方案中发生的唯一性。
结果：在批准治疗成人多动症的7种药物中，在非兴奋剂药物中，在固定和灵活剂量研究的混合过程中经历的副作用类型的数量是最大的，但是兴奋剂药物的副作用发生率更高。所有药物发生不良事件的最小频率为10名参与者中的1名。兴奋剂药物之间，兴奋剂和非兴奋剂之间的总体停药率没有差异。
结论：据我们所知，本研究是首次对所有FDA注册试验的批准用于治疗成人多动症的药物数据进行汇总和比较的研究.本文描述了一个过程，通过该过程，可以将现成的不良事件报告数据用作告知共享临床决策的工具。虽然所包括的试验的方法和结果报告的差异可能会限制普遍性，纳入的个体患者数量和停药数据的完整性可用于与患者讨论不良经历和其他患者担忧的相对可能性.
