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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Respiratory Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1460407

High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database

Provisionally accepted
Zhishen Ruan Zhishen Ruan 1*Dan Li Dan Li 2Shasha Yuan Shasha Yuan 1Yiling Fan Yiling Fan 1Bo Xu Bo Xu 1Xiaodong Cong Xiaodong Cong 1Qing Miao Qing Miao 1
  • 1 Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
  • 2 Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, Beijing Municipality, China

The final, formatted version of the article will be published soon.

    Objective: Single 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).Methods: This 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.Results: 16355 AEs in BUD/GLY/FOR and 39110 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.Our 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.

    Keywords: ：COPD, Asthma, Single-inhaler triple therapy, FAERS, adverse events

    Received: 06 Jul 2024; Accepted: 19 Dec 2024.

    Copyright: © 2024 Ruan, Li, Yuan, Fan, Xu, Cong and Miao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Zhishen Ruan, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.