High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database
ObjectiveSingle inhaler triple therapy is widely used in Chronic Obstructive Pulmonary Disease (COPD) and asthma. This research aimed to analyze adverse events (AEs) associated with Budesonide/Glycopyrronium/Formoterol Fumarate (BUD/GLY/FOR) and Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/V...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1460407/full |
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| author | Zhishen Ruan Chunbin Wang Shasha Yuan Yiling Fan Bo Xu Xiaodong Cong Dan Li Qing Miao |
| author_facet | Zhishen Ruan Chunbin Wang Shasha Yuan Yiling Fan Bo Xu Xiaodong Cong Dan Li Qing Miao |
| author_sort | Zhishen Ruan |
| collection | DOAJ |
| description | ObjectiveSingle inhaler triple therapy is widely used in Chronic Obstructive Pulmonary Disease (COPD) and asthma. This research aimed to analyze adverse events (AEs) associated with Budesonide/Glycopyrronium/Formoterol Fumarate (BUD/GLY/FOR) and Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).MethodsThis is a cross-sectional study. BUD/GLY/FOR (2020Q3-2024Q3) and FF/UMEC/VI (2018Q1-2024Q3) report files were downloaded from the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database. We use reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) for disproportionality analysis. The aim was to explore associations between drugs and preferred term (PT) and system organ classification (SOC) levels. We focused on exploring the top 10 PTs of each drug’s BCPNN (IC) effect value and the PT of pneumonia.Results16,355 AEs in BUD/GLY/FOR and 39,110 AEs in FF/UMEC/VI were extracted. Device use issues, oropharyngeal and vocal problems, pneumonia, candida infections, and urinary retention were the standard PTs present in drug leaflets. The risk of device use issues was higher in BUD/GLY/FOR, whereas the risk of pneumonia and candida infection in FF/UMEC/ VI had higher risk. Outside of the drug leaflets, both drugs were associated with a higher risk of AEs in vascular disorders. BUD/GLY/FOR group had a higher risk of AEs in body height decreased and hypoacusis. Notably, this study found an association between the above PTs and drugs, and the causal relationship needs to be verified by further longitudinal studies.ConclusionOur study provides a preliminary exploration of the safety of clinical use of BUD/GLY/FOR and FF/UMEC/VI, and clinicians should be alert to potential adverse effects. |
| format | Article |
| id | doaj-art-70cea2476a884d3caed826be5269a096 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-70cea2476a884d3caed826be5269a0962025-01-09T06:10:57ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.14604071460407High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS databaseZhishen Ruan0Chunbin Wang1Shasha Yuan2Yiling Fan3Bo Xu4Xiaodong Cong5Dan Li6Qing Miao7Respiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaDongying People’s Hospital (Dongying Hospital of Shandong Provincial Hospital Group), Dongying, Shandong, ChinaRespiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaRespiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaRespiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaRespiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaCardiovascular Department, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaRespiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, ChinaObjectiveSingle inhaler triple therapy is widely used in Chronic Obstructive Pulmonary Disease (COPD) and asthma. This research aimed to analyze adverse events (AEs) associated with Budesonide/Glycopyrronium/Formoterol Fumarate (BUD/GLY/FOR) and Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).MethodsThis is a cross-sectional study. BUD/GLY/FOR (2020Q3-2024Q3) and FF/UMEC/VI (2018Q1-2024Q3) report files were downloaded from the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database. We use reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) for disproportionality analysis. The aim was to explore associations between drugs and preferred term (PT) and system organ classification (SOC) levels. We focused on exploring the top 10 PTs of each drug’s BCPNN (IC) effect value and the PT of pneumonia.Results16,355 AEs in BUD/GLY/FOR and 39,110 AEs in FF/UMEC/VI were extracted. Device use issues, oropharyngeal and vocal problems, pneumonia, candida infections, and urinary retention were the standard PTs present in drug leaflets. The risk of device use issues was higher in BUD/GLY/FOR, whereas the risk of pneumonia and candida infection in FF/UMEC/ VI had higher risk. Outside of the drug leaflets, both drugs were associated with a higher risk of AEs in vascular disorders. BUD/GLY/FOR group had a higher risk of AEs in body height decreased and hypoacusis. Notably, this study found an association between the above PTs and drugs, and the causal relationship needs to be verified by further longitudinal studies.ConclusionOur study provides a preliminary exploration of the safety of clinical use of BUD/GLY/FOR and FF/UMEC/VI, and clinicians should be alert to potential adverse effects.https://www.frontiersin.org/articles/10.3389/fphar.2024.1460407/fullCOPDasthmasingle-inhaler triple therapyFAERSadverse events |
| spellingShingle | Zhishen Ruan Chunbin Wang Shasha Yuan Yiling Fan Bo Xu Xiaodong Cong Dan Li Qing Miao High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database Frontiers in Pharmacology COPD asthma single-inhaler triple therapy FAERS adverse events |
| title | High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database |
| title_full | High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database |
| title_fullStr | High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database |
| title_full_unstemmed | High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database |
| title_short | High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database |
| title_sort | high risk adverse events in two types of single inhaler triple therapy a pharmacovigilance study based on the faers database |
| topic | COPD asthma single-inhaler triple therapy FAERS adverse events |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1460407/full |
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