Signal mining and analysis of adverse events of four LAMA drugs based on the FAERS database

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Author: QIN Honghua ^1, ² GUO Haiyan ¹ YANG Liu ^1, ² WANG Ying ¹  TONG Xiaona ² LI Haifeng ²

Affiliation: 1. School of Pharmacy, Dali University, Dali 671000, Yunnan Province, China 2. Department of Pharmacy, the Third People’s Hospital of Yunnan Province, Kunming 650011, China

Keywords: Aclidinium bromide Glycopyrronium bromide Umeclidinium bromide Tiotropium bromide Adverse drug event Signal mining Pharmacovigilance FAERS database

DOI: 10.12173/j.issn.1005-0698.202407026

Reference: QIN Honghua, GUO Haiyan, YANG Liu, WANG Ying, TONG Xiaona, LI Haifeng.Signal mining and analysis of adverse events of four LAMA drugs based on the FAERS database[J].Yaowu Liuxingbingxue Zazhi,2024, 33(10):1081-1090.DOI: 10.12173/j.issn.1005-0698.202407026.[Article in Chinese]  Copied

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Abstract

Objective To investigate and assess the risk signals of adverse drug events (ADEs) associated with the post-marketing 4 long-acting anticholinergic antagonists (LAMA), including adionium bromide, glycopyrronium bromide, umeonium bromide, and tiotropium bromide, to provide references for clinically safe prescribing practices.

Methods Four LAMA drugs-related ADE records were selected by searching the FAERS database from the first quarter of 2004 to the first quarter of 2024 and standardizing the drug name of adionium bromide, glycopyrronium bromide, umeonium bromide, and tiotropium bromide, with the primary suspected drug as a restriction. Potential ADE signals were mined using the reporting odds ratio (ROR) method, medicines and healthcare products regulatory agency (MHRA) method and Bayesian confidence propagation neural network (BCPNN) method, and Medical Dictionary for Drug Regulatory Activities 26.1 was used to classify the results systematically.

Results A total of 80 680 reports of four LAMA drugs-related ADE were collected, including 4 287 reports for aclidinium bromide, 3 584 reports for glycopyrronium bromide, 3 084 reports for umeclidinium bromide and 69 725 reports for iotropium bromide. The reports predominantly involved female patients (47 725 cases, 59.15%) over male patients (27 525 cases, 34.11%). The United States emerged as the principal reporting country, with consumers, pharmacists, and physicians as the primary reporters. Serious ADE outcomes included life-threatening conditions, hospitalizations, disabilities, deaths. A total of 902 signals were identified, mainly affecting 27 systems or organs. Specifically, aclidinium bromide (180 signals), glycopyrronium bromide (210 signals), umeclidinium bromide (142 signals), and tiotropium bromide (370 signals) exhibited signals predominantly in the respiratory, thoracic and mediastinal disorders, investigations, injury, poisoning and procedural complications, eye and organ diseases cgastrointestinal disorders.

Conclusion When using LAMA drugs for respiratory conditions, clinicians should implement preventive measures to monitor respiratory diseases, thoracic and mediastinal diseases, eye and organ changes and various laboratory examination indicators, to reduce the risk of medication.

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