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

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 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. 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 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.

骨质疏松症（Osteoporosis, OP）是以骨量降低和骨折风险升高为特征的常见骨骼疾病。特立帕肽（Teriparatide, TP）与阿巴洛帕肽（abaloparatide, ABL）属于合成代谢制剂，可降低骨折发生率，但二者对肌肉骨骼与结缔组织疾病（musculoskeletal and connective tissue disorders, MCTD）风险的影响尚不明确。本研究采用2004年第一季度至2023年第三季度的FDA不良事件报告系统（FDA Adverse Event Reporting System, FAERS）数据，开展了一项回顾性观察性不成比例分析，以特立帕肽或阿巴洛帕肽作为首要可疑药物。本研究运用多种数据挖掘算法，包括报告比值比（reporting odds ratio, ROR）、比例报告比（proportional reporting ratio, PRR）、贝叶斯置信传播神经网络（Bayesian confidence propagation neural network, BCPNN）以及多项目伽马泊松收缩器（multi-item gamma Poisson shrinker, MGPS），以检测肌肉骨骼与结缔组织疾病的安全性信号。最终共纳入366747例与特立帕肽相关、422377例与阿巴洛帕肽相关的不良事件病例，受试者以年龄≥45岁的女性为主。排名靠前的具体不良事件（Adverse Event, AE）涉及肌肉骨骼、结缔组织及给药部位相关疾病。对比分析显示，与特立帕肽相比，阿巴洛帕肽相关的神经系统、心血管系统及胃肠道系统不良事件发生率更高。两种药物均在关节痛、肢体疼痛、背痛、肌肉痉挛、骨痛、肌肉疼痛及肌无力方面表现出较强的安全性信号。本分析提示，骨质疏松症患者接受特立帕肽或阿巴洛帕肽治疗时，存在发生肌肉骨骼与结缔组织疾病的潜在风险，凸显了临床实践中开展不良事件监测与管理的必要性。本研究有助于进一步明确此类合成代谢制剂的安全性特征。