Lin Binx Yezhe, Lessard Chloe, Li Yifan, Gong Lisa, Ling Ruth, Jyotsana Pallawi, Steinle Jacob, Borodovsky Jacob T, Nascimento Fábio A, Xu Kevin Y
Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, United States.
Carilion Clinic, Virginia Tech Carilion School of Medicine, Roanoke, VA, United States.
Drug Alcohol Depend Rep. 2024 Nov 22;13:100303. doi: 10.1016/j.dadr.2024.100303. eCollection 2024 Dec.
Off-label prescribing of Epidiolex® (pharmaceutical cannabidiol) comes with both potential benefits and risks for patients. The aims of this study were to: (1) identify the percentage of people prescribed Epidiolex® who do not have diagnostic indications for Epidiolex® (Lennox Gastaut Syndrome [LGS], Dravet Syndrome [DS], and Tuberous Sclerosis Complex [TSC]) and (2) examine potential co-prescribing of medications that may interact with Epidiolex®.
Using TriNetX analytics, a web-based database of de-identified electronic health records spanning >110 million people in the United States, we analyzed 4214 people receiving Epidiolex® in 2022. We computed the number of people prescribed Epidiolex® who did not have diagnoses for LGS, DS, or TSC. We evaluated the prevalence of co-occurring prescriptions that are known to interact with cannabidiol following each individual's first Epidiolex® prescription.
Among individuals receiving Epidiolex®, 40 % did not have FDA-approved diagnostic indications (LGS/DS/TSC) in the medical record. In the overall sample, co-occurring psychotropic prescribing was prevalent, including medications with known interactions with cannabidiol (Clobazam=47.2 %; Diazepam=47.4 %; Clonazepam=40.7 %). Among individuals without LGS/DS/TSC who received Epidiolex®, the most common diagnoses received following the index prescription were unspecified epileptic syndromes (53.8 %), sleep disorders (25.7 %), anxiety disorders (25.9 %), mood disorders (18.6 %) and autism spectrum disorders (10.8 %).
Off-label prescribing and co-prescription of medications with known interactions with cannabidiol is prevalent. Further research is needed to elucidate longitudinal outcomes associated with off-label Epidiolex® prescribing.
Epidiolex®（药用大麻二酚）的超说明书用药对患者既有潜在益处，也有风险。本研究的目的是：（1）确定开具Epidiolex®处方但无Epidiolex®诊断指征（伦诺克斯·加斯托综合征[LGS]、德雷维特综合征[DS]和结节性硬化症[TSC]）的人群比例，以及（2）检查可能与Epidiolex®相互作用的药物的联合处方情况。
使用TriNetX分析工具，这是一个基于网络的去识别电子健康记录数据库，涵盖美国超过1.1亿人，我们分析了2022年接受Epidiolex®治疗的4214人。我们计算了开具Epidiolex®处方但未诊断为LGS、DS或TSC的人数。我们评估了在每个人首次开具Epidiolex®处方后已知与大麻二酚相互作用的同时开具的处方的患病率。
在接受Epidiolex®治疗的个体中，40%在病历中没有FDA批准的诊断指征（LGS/DS/TSC）。在总体样本中，同时开具精神药物很普遍，包括与大麻二酚有已知相互作用的药物（氯巴占=47.2%；地西泮=47.4%；氯硝西泮=40.7%）。在接受Epidiolex®治疗但无LGS/DS/TSC的个体中，索引处方后最常见的诊断是未特定的癫痫综合征（53.8%）、睡眠障碍（25.7%）、焦虑症（25.9%）、情绪障碍（18.6%）和自闭症谱系障碍（10.8%）。
与大麻二酚有已知相互作用的药物的超说明书用药和联合处方很普遍。需要进一步研究以阐明与Epidiolex®超说明书用药相关的纵向结果。
