Mack Alicia
PharmD, Clinical Pharmafy Coordinator, Three Rivers Administrative Services, Monroeville, PA 15146, USA.
J Manag Care Pharm. 2003 Nov-Dec;9(6):559-68. doi: 10.18553/jmcp.2003.9.6.559.
(1) Describe the relevance of off-label use of gabapentin to managed care pharmacy; (2) summarize recent FDA warnings and media reports related to off-label gabapentin use; (3) review medical information pertaining to the off-label use of gabapentin; (4) outline alternatives to off-label use of gabapentin in an evidence-based fashion, where literature exists to support such alternatives; and (5) encourage key clinicians and decision makers in managed care pharmacy to develop and support programs that restrict the use of gabapentin to specific evidence-based situations.
Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for adjunctive therapy in treatment of partial seizures and postherpetic neuralgia. Various off-label (unapproved) uses have been reported, and the use of gabapentin for off-label purposes has reportedly exceeded use for FDAapproved indications. Pharmaceutical marketing practices and physician dissatisfaction with currently available pharmacological treatment options may be key factors that contribute to this prescribing trend. Recently, the media has focused on these issues, noting that many cases of reported safety and effectiveness of gabapentin for off-label use may have been fabricated. A thorough review of the medical and pharmacy literature related to off-label use of gabapentin was performed, and a summary of the literature for the following conditions is presented: bipolar disorder, peripheral neuropathy, diabetic neuropathy, complex regional pain syndrome, attention deficit disorder, restless legs syndrome, trigeminal neuralgia, periodic limb movement disorder of sleep, migraine headaches, and alcohol withdrawal syndrome. A common theme in the medical literature for gabapentin is the prevalence of open-label studies and a lack of randomized controlled clinical trials for all but a small number of indications.
In the majority of circumstances where it has reported potential for.off-label. use, gabapentin is not the optimal treatment. The off-label use of gabapentin for indications not approved by the FDA should be reserved for cases where there is solid research support (e.g., diabetic neuropathy and prophylaxis of frequent migraine headaches). Managed care pharmacists should develop programs to restrict the use of gabapentin to these specific evidence-based situations, and key decision makers in managed care practice should feel confident in supporting these use restrictions for gabapentin.
（1）描述加巴喷丁的非标签使用与管理式医疗药房的相关性；（2）总结美国食品药品监督管理局（FDA）近期关于加巴喷丁非标签使用的警告及媒体报道；（3）回顾与加巴喷丁非标签使用相关的医学信息；（4）在有文献支持替代方案的情况下，以循证方式概述加巴喷丁非标签使用的替代方案；（5）鼓励管理式医疗药房的关键临床医生和决策者制定并支持将加巴喷丁的使用限制在特定循证情况下的项目。
加巴喷丁已获美国食品药品监督管理局（FDA）批准用于辅助治疗部分性癫痫发作和带状疱疹后神经痛。已报道了各种非标签（未获批）用途，且据报道加巴喷丁用于非标签用途的情况已超过其获批适应症的使用情况。药品营销做法以及医生对现有药物治疗选择的不满可能是导致这种处方趋势的关键因素。近期，媒体关注了这些问题，指出许多关于加巴喷丁非标签使用的安全性和有效性的报道案例可能是编造的。对与加巴喷丁非标签使用相关的医学和药学文献进行了全面回顾，并呈现了以下病症的文献总结：双相情感障碍、周围神经病变、糖尿病性神经病变、复杂性区域疼痛综合征、注意力缺陷障碍、不宁腿综合征、三叉神经痛、睡眠周期性肢体运动障碍、偏头痛以及酒精戒断综合征。加巴喷丁医学文献中的一个共同主题是开放标签研究的普遍性以及除少数适应症外缺乏随机对照临床试验。
在大多数已报道有非标签使用可能性的情况下，加巴喷丁并非最佳治疗药物。加巴喷丁用于FDA未批准适应症的非标签使用应仅保留给有确凿研究支持的情况（例如，糖尿病性神经病变和预防频繁偏头痛）。管理式医疗药剂师应制定项目，将加巴喷丁的使用限制在这些特定的循证情况下，管理式医疗实践中的关键决策者应放心支持对加巴喷丁的这些使用限制。
