Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan; Department of Clinical Pharmacy, Fujita Health University School of Medicine, Toyoake, Aichi, Japan; Office of Clinical Pharmacy Practice and Health Care Management, Faculty of Pharmacy, Meijo University, Nagoya, Aichi, Japan.
Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan; Office of Clinical Pharmacy Practice and Health Care Management, Faculty of Pharmacy, Meijo University, Nagoya, Aichi, Japan.
Psychiatry Res. 2020 Sep;291:113249. doi: 10.1016/j.psychres.2020.113249. Epub 2020 Jun 23.
This study aims to assess the differences in adverse event profiles of long-acting injectable antipsychotics (LAIs) and oral antipsychotics (OAPs) using real-world data in the Japanese Adverse Drug Event Report database. Reporting odds ratios were determined using disproportionality analysis to estimate the risk of adverse events for LAIs and OAPs. Differences in adverse event profiles between formulations were determined after propensity score matching. Time-to-onset of adverse events was compared between LAIs and OAPs using the Weibull shape parameter. Signals were detected for approximately 50% of the adverse events (12 of 22) with LAIs and for the majority of adverse events (19 of 22) with OAPs. LAIs was associated with significantly lower reporting rate than OAPs for extrapyramidal symptom, neuroleptic malignant syndrome, and dystonia. For QT prolongation, convulsions, and hyperglycemia associated with LAIs, the 95% Confidence Interval of β included 1 in time-to-onset analysis. Real-world data suggest that LAIs tend to reduce the occurrence of extrapyramidal symptom and neuroleptic malignant syndrome, but a number of other adverse events have potential risks as well as OAPs. In addition, onset of adverse events with LAIs have been shown to be slightly delayed, requiring more careful long-term monitoring.
本研究旨在使用日本药物不良反应报告数据库中的真实世界数据，评估长效注射型抗精神病药（LAIs）和口服抗精神病药（OAPs）的不良事件谱差异。使用不稳定性分析来确定报告比值比，以估计 LAIs 和 OAPs 不良事件的风险。在倾向评分匹配后，确定不同制剂之间的不良事件谱差异。使用 Weibull 形状参数比较 LAIs 和 OAPs 之间不良事件的发生时间。LAIs 和 OAPs 分别约有 50%（12/22）和大多数不良事件（19/22）存在信号。与 OAPs 相比，LAIs 与锥体外系症状、恶性神经阻滞剂综合征和肌张力障碍的报告率显著降低。对于与 LAIs 相关的 QT 延长、癫痫发作和高血糖，β在发生时间分析中的 95%置信区间包含 1。真实世界数据表明，LAIs 可能会降低锥体外系症状和恶性神经阻滞剂综合征的发生，但其他一些不良事件与 OAPs 一样存在潜在风险。此外，LAIs 不良事件的发生时间略有延迟，需要更仔细的长期监测。
