特立帕肽的适应症和不良事件:基于FDA不良事件报告系统(FAERS)。
Indications and adverse events of teriparatide: based on FDA adverse event reporting system (FAERS).
发表日期:2024
作者:
Ming-Tao Wen, Jia-Cheng Li, Bo-Wen Lu, Hua-Rong Shao, Pei-Xue Ling, Fei Liu, Gang Li, Di Luo
来源:
Frontiers in Pharmacology
摘要:
特立帕肽被批准用于治疗骨质疏松症。鉴于其广泛使用,上市后监测至关重要。利用 FAERS 数据库调查与特立帕肽相关的不良事件 (AE),比较关键 AE 的关联强度,并探索潜在应用以提供临床参考。分析了 2004 年至 2023 年的 FAERS 数据。其中包括特立帕肽是主要可疑药物的报告。不良事件被映射到系统器官类别和首选术语。使用 ROR、PRR、BCPNN 和 EBGM 算法进行不成比例分析来检测安全信号。在以特立帕肽为主要嫌疑的 107,123 份报告中,确定的关键 AE 包括四肢疼痛 (PRR: 4.54)、肌肉痉挛 (PRR: 5.11)、骨折(PRR 范围:17.67-552.95)和钙水平升高(PRR:50.73)。与骨折(PRR 范围:17.67-552.95)相比,特立帕肽与钙水平升高(PRR:50.73)表现出更强的相关性。值得注意的是,只有 10.86% 的 AE 报告由医生提交,另外 10% 由其他卫生专业人员提交。子集分析显示,与一般数据集相比,卫生专业人员报告的 AE 具有更高的一致性。在关节炎(0.57%)和癌症(0.12%)等疾病中注意到超说明书使用。对于骨质疏松症,主要 AE 是疼痛(18.2%)、骨折(12.4%)、肌肉痉挛(7.7%)和恶心(6.5%),而糖皮质激素引起的骨质疏松症 AE 包括骨折(24.1%)、疼痛(13.2%) 、骨密度降低 (9.8%) 和恶心 (5.1%)。我们的研究结果提供了特立帕肽的真实安全性数据,揭示了关键的 AE 及其关联强度。医疗保健专业人士的报告比例较低,表明需要谨慎解读。持续警惕和进一步研究对于指导特立帕肽的临床使用势在必行。版权所有 © 2024 Wen、Li、Lu、Shao、Ling、Liu、Li 和 Luo。
Teriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.To investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for key AEs, and explore potential applications to provide clinical reference.FAERS data from 2004 to 2023 were analyzed. Reports where teriparatide was the primary suspect drug were included. Adverse events were mapped to System Organ Classes and Preferred Terms. Disproportionality analysis using ROR, PRR, BCPNN and EBGM algorithms was conducted to detect safety signals.Out of 107,123 reports with teriparatide as the primary suspect, key AEs identified included pain in extremity (PRR: 4.54), muscle spasms (PRR: 5.11), fractures (PRR range: 17.67-552.95), and increased calcium levels (PRR: 50.73). Teriparatide exhibited a stronger association with increased calcium levels (PRR: 50.73) compared to fractures (PRR range: 17.67-552.95). Notably, only 10.86% of AE reports were submitted by physicians and another 10% by other health professionals. Subset analyses showed a higher consistency of reported AEs from health professionals compared to the general dataset. Off-label uses were noted in conditions such as arthritis (0.57%) and cancer (0.12%). For osteoporosis, main AEs were pain (18.2%), fractures (12.4%), muscle spasms (7.7%), and nausea (6.5%), while glucocorticoid-induced osteoporosis AEs included fractures (24.1%), pain (13.2%), decreased bone density (9.8%), and nausea (5.1%).Our findings provide real-world safety data on teriparatide, revealing key AEs and their association strengths. The low proportion of reports by healthcare professionals suggests the need for cautious interpretation. Continuous vigilance and further research are imperative to guide teriparatide's clinical use.Copyright © 2024 Wen, Li, Lu, Shao, Ling, Liu, Li and Luo.