Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS).

IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-07-18 DOI:10.1080/14740338.2024.2382228
Ming-Tao Wen, Di Luo, Jia-Cheng Li, Bo-Wen Lu, Pei-Xue Ling, Fei Liu, Gang Li
{"title":"Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS).","authors":"Ming-Tao Wen, Di Luo, Jia-Cheng Li, Bo-Wen Lu, Pei-Xue Ling, Fei Liu, Gang Li","doi":"10.1080/14740338.2024.2382228","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Osteoporosis (OP), characterized by low bone mass and increased fracture risk, is a prevalent skeletal disorder. Teriparatide (TP) and abaloparatide (ABL) are anabolic agents that may reduce fracture incidence, but their impact on musculoskeletal and connective tissue disorders (MCTD) risk is uncertain.</p><p><strong>Research design and methods: </strong>A retrospective, observational disproportionality analysis was conducted utilizing FAERS data from Q1 2004 to Q3 2023, where TP or ABL was identified as the primary suspect drug. Multiple data mining algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to detect MCTD safety signals.</p><p><strong>Results: </strong>A total of 366,747 TP-related and 422,377 ABL-related cases were identified, predominantly among female patients aged ≥45 years. The top specific AEs involved musculoskeletal, connective tissue, and administration site disorders. Comparative analysis revealed a higher frequency of AEs related to the nervous, cardiovascular, and gastrointestinal systems for ABL compared to TP. Both drugs exhibited strong signals for arthralgia, limb pain, back pain, muscle spasms, bone pain, muscle pain, and muscle weakness.</p><p><strong>Conclusion: </strong>The analysis suggests a potential MCTD risk with TP and ABL treatment in OP patients, highlighting the need for AE monitoring and management in clinical practice. This contributes to a better understanding of the safety profiles of these anabolic medications.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1001-1010"},"PeriodicalIF":3.1000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14740338.2024.2382228","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/18 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Osteoporosis (OP), characterized by low bone mass and increased fracture risk, is a prevalent skeletal disorder. Teriparatide (TP) and abaloparatide (ABL) are anabolic agents that may reduce fracture incidence, but their impact on musculoskeletal and connective tissue disorders (MCTD) risk is uncertain.

Research design and methods: A retrospective, observational disproportionality analysis was conducted utilizing FAERS data from Q1 2004 to Q3 2023, where TP or ABL was identified as the primary suspect drug. Multiple data mining algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to detect MCTD safety signals.

Results: A total of 366,747 TP-related and 422,377 ABL-related cases were identified, predominantly among female patients aged ≥45 years. The top specific AEs involved musculoskeletal, connective tissue, and administration site disorders. Comparative analysis revealed a higher frequency of AEs related to the nervous, cardiovascular, and gastrointestinal systems for ABL compared to TP. Both drugs exhibited strong signals for arthralgia, limb pain, back pain, muscle spasms, bone pain, muscle pain, and muscle weakness.

Conclusion: The analysis suggests a potential MCTD risk with TP and ABL treatment in OP patients, highlighting the need for AE monitoring and management in clinical practice. This contributes to a better understanding of the safety profiles of these anabolic medications.

比较特立帕肽和阿巴帕肽治疗骨质疏松症的肌肉骨骼和结缔组织疾病风险:基于 FDA 不良事件报告系统 (FAERS) 的分析。
背景:骨质疏松症(OP)是一种常见的骨骼疾病,其特点是骨量减少和骨折风险增加。特立帕肽(TP)和阿巴拉帕肽(ABL)等同化制剂已被用于刺激骨形成和降低骨折发生率。然而,使用这些药物是否会增加肌肉骨骼和结缔组织疾病(MCTD)的风险仍不清楚:利用 2004 年第一季度至 2023 年第三季度的 FAERS 数据进行了一项回顾性、观察性比例失调分析,其中 TP 或 ABL 被确定为主要可疑药物。采用多种数据挖掘算法,包括报告几率比(ROR)、比例报告比(PRR)、贝叶斯置信度传播神经网络(BCPN)和多项目伽马泊松收缩器(MGPS)来检测 MCTD 安全信号:共发现366,747例TP相关病例和422,377例ABL相关病例,主要是年龄≥45岁的女性患者。最常见的特异性 AE 涉及肌肉骨骼、结缔组织和用药部位疾病。比较分析显示,与TP相比,ABL发生神经、心血管和胃肠道系统相关不良反应的频率更高。两种药物在关节痛、肢体痛、背痛、肌肉痉挛、骨痛、肌肉痛和肌无力方面都表现出强烈的信号:这项基于 FAERS 的数据挖掘分析强调了与骨质疏松症患者接受 TP 和 ABL 治疗相关的潜在 MCTD 风险概况,强调了在临床实践中监测和管理这些 AE 的重要性。这些发现有助于加深对这些同化性骨质疏松症药物安全性的理解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信