与地诺单抗相关的低钙血症事件:来自 FDA 不良事件报告系统 (FAERS) 数据库的真实世界研究。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS
Siyuan Gao, Guanhao Zheng, Zhichao He, Lishi Chen, Dengfeng Yan, Zhisheng Lai, Tingfeng Cai, Shijie Hu
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引用次数: 0

摘要

背景和目的:地诺单抗被广泛用于骨质疏松症和癌症治疗。然而,由地诺单抗诱发的低钙血症是一种常见的不良事件。本研究旨在全面调查通过美国食品药品管理局(FDA)不良事件报告系统(FAERS)报告的真实世界患者病例中低钙血症的安全信号和发生情况:方法:从FAERS中提取2017年1月1日至2021年12月31日的报告。只有疑似地诺单抗引起的低钙血症病例才符合药物警戒研究的条件。根据临床特征确定了与地诺单抗相关的低钙血症安全信号。使用报告几率比(ROR)评估低钙血症的安全信号:在102413例与地诺单抗相关的病例中,有1042例报告了与地诺单抗相关的低钙血症。患者主要为老年人(中位年龄 70 岁)和男性(568 人,占 63.5%)。在现有数据中,中位发病时间为 23 天(0-1601 天)。大多数患者需要中断服药(226 人,72.9%),并能达到恢复缓解状态(318 人,62.1%)。在整个数据库中,地诺单抗显示出低钙血症的安全信号(ROR = 14.09,95% Cl 13.18,15.06)。在敏感性分析中,地诺单抗也显示出癌症(ROR = 21.28,95% Cl 18.79,24.11)和骨质疏松症(ROR = 9.29,95% Cl 6.80,12.59)低钙血症的安全信号。与双膦酸盐相比,地诺单抗仍存在低钙血症的安全信号(ROR = 1.88,95% Cl 1.67,2.11):这项药物警戒数据库分析表明,与地诺单抗相关的低钙血症具有较高的安全性,尤其是在癌症患者中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database.

Background and objective: Denosumab is widely used for osteoporosis and cancer treatment. However, hypocalcemia induced by denosumab is a frequent adverse event. The objective of this study is to comprehensively investigate the safety signals and the occurrence of hypocalcemia in real-world patient cases reported through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Methods: Reports from January 1, 2017 to December 31, 2021 were extracted from the FAERS. Only cases of hypocalcemia suspected to denosumab were eligible in pharmacovigilance study. Denosumab-related hypocalcemia safety signal were identified to characterize their clinical features. A safety signal for hypocalcemia was evaluated using reporting odds ratios (ROR).

Results: Among the 102,413 cases related to denosumab, 1042 cases were reported with denosumab-related hypocalcemia. The affected patients were mainly elderly (median age 70 years) and male (n = 568, 63.5%). In available data, the median onset time of 23 (range 0-1601) days. Most patients required drug interruption (n = 226, 72.9%) and can achieve a recovered-resolved state (n = 318, 62.1%). For the whole database, denosumab exhibited a safety signal for hypocalcemia (ROR = 14.09, 95% Cl 13.18, 15.06). In the sensitivity analyses, denosumab also showed a safety signal for hypocalcemia in cancer (ROR = 21.28, 95% Cl 18.79, 24.11) and osteoporosis (ROR = 9.29, 95% Cl 6.80, 12.59). Compared with bisphosphonates, denosumab still has safety signal for hypocalcemia (ROR = 1.88, 95% Cl 1.67, 2.11).

Conclusions: This pharmacovigilance database analysis indicates a high safety signal for hypocalcemia associated with denosumab, particularly in cancer patients.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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