Risk signal mining of adverse events related to inclisiran based on FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20231218-00910
- VernacularTitle:基于美国FDA不良事件报告系统数据库的英克司兰不良事件风险信号挖掘
- Author:
Xinglong WANG
1
;
Qingyuan HU
1
;
Jie BAI
1
;
Zhihui SONG
1
Author Information
1. 首都医科大学附属北京同仁医院药学部，北京 100730
- Publication Type:Journal Article
- Keywords:
Hypolipidemic agents;
Safety;
RNA, small interfering;
Inclisiran;
Adverse events
- From:
Adverse Drug Reactions Journal
2024;26(4):223-228
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the risk of adverse event (AE) associated with inclisiran and to provide reference for the safe use in clinical practice.Methods:The AE reports in the US FDA Adverse Event Reporting System (FAERS) database from the 4th quarter of 2004 to the 2nd quarter of 2023 with inclisiran as the primary suspect drug were collected. AE was standardized and classified using the preferred terminology (PT) and the system organ class (SOC) of the Medical Dictionary for Regulatory Activities 26.0. AE risk signal mining was performed using the report odds ratio (ROR) method and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method. PT that was considered as an AE risk signal in both methods were defined as AE risk signals [ROR method: ≥3 reports and the lower limit of the 95% confidence interval ( CI) of the ROR>1; MHRA comprehensive standard method: ≥3 reports、 PRR ≥2 and χ2≥4]. A descriptive statistical analysis was performed. Results:A total of 1 888 AE reports were collected with inclisiran as the primary suspect drug, involving 1 888 patients and 835 PTs. The AE was predominantly reported in the United States (88.7%, 1 675/1 888), and predominantly by the consumer (62.1%, 1 171/1 886); there were a total of 484 reports (25.6%) about serious AE. Excluding non-drug and indication-related PTs, 85 PTs (involving 15 SOCs) met the criteria in both the ROR method and the MHRA comprehensive standard method, and defined as AE risk signals. The top 5 PTs ranked by the number of reports were arthralgia (248 cases), injection site pain (237 cases), limb pain (170 cases), myalgia (158 cases), and diarrhea (132 cases); the top 5 PTs ranked by the signal intensity included bladder discomfort ( ROR=28.87, PRR=28.85), injection site discomfort ( ROR=24.48, PRR=24.40), sinus pain ( ROR=23.20, PRR=23.19), injection site vesicles ( ROR=17.63, PRR=17.61), and injection site rash ( ROR=12.51, PRR=12.45). Among the top 20 PTs ranked according to the number of reports and signal intensity respectively, 8 and 13 PTs were not documented in domestic and international specifications, of which myalgia and hypoacusis had more reports and stronger signal intensity. Conclusion:The main AE of inclisiran in the US FAERS database were injection site reactions, followed by musculoskeletal-related AEs (arthralgia, myalgia, and myospasm, etc.) and infection-related AEs (such as urinary tract infections and bronchitis), which require clinical attention.
