Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China.
Osteoporos Int. 2023 Dec;34(12):2047-2058. doi: 10.1007/s00198-023-06877-6. Epub 2023 Aug 18.
Abaloparatide (ABL) is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture. However, real-world data regarding its long-term safety and tolerability in large sample population are incomplete. We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
We investigated 33,480(0.14%) ABL-related adverse events (AEs) through data mining of Food and Drug Administration Adverse Event Reporting System (FAERS) retrospectively.
Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed to quantify the signals of ABL-related AEs from 2017Quarter2 to 2022.Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (χ) test.
We collected 8,470,497 reports from the FAERS database, including 11,487 reports defined ABL as the primary suspected (PS) drug. Additionally, 36.16% of the reports were submitted by healthcare professionals (n=4154), compared to 62.26% reported by consumers (n=7140). A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals. Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13). Patient age (p < 0.001) might be associated with an increased risk of AEs severity. The most common timeframe for AE occurrence was 0-7 days.
Our study provided a deeper and broader understanding of abaloparatide's safety profiles, which would help healthcare professionals to mitigate the risk of AEs in clinical practice, a low number of unexpected AEs supporting ongoing additional pharmacovigilance.
阿巴洛肽（ABL）是一种获得美国食品和药物管理局批准的甲状旁腺激素相关肽类似物，用于治疗绝经后骨折高危妇女的骨质疏松症。然而，关于其在大样本人群中的长期安全性和耐受性的真实世界数据并不完整。我们通过数据挖掘食品和药物管理局药物警戒数据库来评估阿巴洛肽相关的安全性信号。
我们通过数据挖掘食品和药物管理局不良事件报告系统（FAERS）回顾性地调查了 33480 例（0.14%）ABL 相关不良事件（AE）。报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项伽马泊松收缩器（MGPS）用于从 2017 年第 2 季度到 2022 年定量分析 ABL 相关 AE 的信号。严重和非严重病例通过 Mann-Whitney U 检验或卡方（χ）检验进行比较。
我们从 FAERS 数据库中收集了 8470497 份报告，其中包括 11487 份将 ABL 定义为主要怀疑（PS）药物的报告。此外，36.16%的报告由医疗保健专业人员（n=4154）提交，而 62.26%的报告由消费者（n=7140）提交。同时符合四种算法的共检测到 99 个信号，其中 35 个信号被确定为意外信号。例如生长痛（n=13）、腰围增加（n=21）、感觉障碍（n=103）、耳鸣（n=65）、视力下降（n=54）、血碱性磷酸酶升高（n=61）和毛发生长异常（n=13）。患者年龄（p<0.001）可能与 AE 严重程度的风险增加有关。AE 发生的最常见时间段为 0-7 天。
本研究更深入、更广泛地了解了阿巴洛肽的安全性概况，这将有助于医疗保健专业人员在临床实践中降低 AE 风险，低数量的意外 AE 支持持续进行额外的药物警戒。
