Changing Patterns of Alpha Agonist Medication Use in Children and Adolescents 2009-2011
Changing Patterns of Alpha Agonist Medication Use in Children and Adolescents 2009-2011
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DOI：
10.1089/cap.2014.0122
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发表时间：
2015-05-01
影响因子：
1.9
通讯作者：
Leslie, Laurel K.
中科院分区：
文献类型：
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作者：
Fiks, Alexander G.;Mayne, Stephanie L.;Leslie, Laurel K.
目的：本研究的目的是描述美国食品和药物管理局 (FDA) 批准长效 α 受体激动剂胍法辛和可乐定后，初级保健人群使用长效和短效 α 受体激动剂治疗行为问题的比率和模式。 方法：从 45 个美国初级保健机构的样本中筛选出 2009 年至 2011 年间接受过 α 受体激动剂处方的 4-18 岁儿童和青少年。在两个基于电子健康记录的研究网络中。阿尔法激动剂收据是使用国家药品代码和药品名称来识别的。计算并检查每年接受长效和短效处方的受试者比例，并根据报告的心理健康诊断、使用适应症是否在标签上、有临床试验证据或没有试验证据进行检查。 结果：在 282,875 名受试者的队列中，27,671 名受试者（10%）接受了任何精神药物，只有 4,227 名受试者（1.5%）接受了至少一种 α 激动剂处方，最常见的是短效制剂（83%）。只有 20% 的 α 激动剂使用符合说明书（使用长效制剂治疗注意力缺陷/多动症 [ADHD]）。大多数受试者（68%）接受α受体激动剂治疗，其适应症有临床试验证明有效，但未经FDA批准，主要是治疗多动症和自闭症的短效制剂； 12% 的人因缺乏儿童随机临床试验证据的诊断而接受 α 受体激动剂治疗，包括睡眠障碍和焦虑，或没有记录的心理健康诊断。长效 α 受体激动剂的使用率从 0.2% 增加到 4%，增加了 20 多倍，而短效 α 受体激动剂的使用率在 2009 年至 2011 年间仅略有增长，从 10.6% 增加到 11.3%。结论：α 受体激动剂的使用在该人群中并不常见，大多数受试者在适应症外但有临床试验证据的情况下接受短效药物治疗。对于睡眠障碍和焦虑等疾病的安全性和有效性，缺乏随机试验的证据，值得进一步研究。
Objectives: The purpose of this study was to describe rates and patterns of long- and short-acting alpha agonist use for behavioral problems in a primary care population following Food and Drug Administration (FDA) approval of the long-acting alpha agonists guanfacine and clonidine.Methods: Children and adolescents 4-18 years of age, who received an alpha agonist prescription between 2009 and 2011, were identified from a sample of 45 United States primary care practices in two electronic health record-based research networks. Alpha agonist receipt was identified using National Drug Codes and medication names. The proportion of subjects receiving long- and short-acting prescriptions in each year was calculated and examined with respect to reported mental health diagnoses, and whether indications for use were on-label, had evidence from clinical trials, or had no trial evidence.Results: In a cohort of 282,875 subjects, 27,671 (10%) received any psychotropic medication and only 4,227 subjects (1.5%) received at least one prescription for an alpha agonist, most commonly a short-acting formulation (83%). Only 20% of alpha agonist use was on-label (use of long-acting formulations for attention-deficit/hyperactivity disorder [ADHD]). Most subjects (68%) received alpha agonists for indications with evidence of efficacy from clinical trials but no FDA approval, primarily short-acting formulations for ADHD and autism; 12% received alpha agonists for diagnoses lacking randomized clinical trial evidence in children, including sleep disorders and anxiety, or for which there was no documented mental health diagnosis. Rates of long-acting alpha agonist use increased more than 20-fold from 0.2% to 4%, whereas rates of short-acting alpha agonist use grew only slightly between 2009 and 2011 from 10.6% to 11.3%.Conclusions: Alpha agonist use was uncommon in this population, and most subjects received short-acting forms for conditions that were off-label, but with clinical trial evidence. The safety and efficacy of use for conditions, including sleep disorders and anxiety, lacking evidence from randomized trials, warrant further investigation.