Mining of Adverse Event Signals Associated with Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy: A Post-Marketing Analysis Based on FAERS.

ABSTRACT: Chronic obstructive pulmonary disease (COPD) is a major global health burden. The fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) triple therapy provides new treatment, but its long-term real-world safety lacks evidence. A post-marketing analysis used the FAERS database to identify adverse event (AE) signals for FF/UMEC/VI. Disproportionality methods including reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM), were applied to detect AE signals, focusing on reports from third quarter (Q3) 2019 to Q3 2024. Among 16,238 reports listing FF/UMEC/VI as primary suspect, significant AE signals occurred in 'injury, poisoning and procedural complications' (n = 9067, ROR 2.46, PRR 2.08, IC 1.06,

SUBMITTER: Chen J 

PROVIDER: S-EPMC12737015 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature