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

Jiajun Chen, Ying Qiao, Gaoxing Qiao, Xiaocan Jia, Jicun Zhu

Abstract read

In one paragraph

Article in Pharmacy (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jiajun ChenDepartment of Medical Services, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.

Ying QiaoDepartment of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.

Gaoxing QiaoDepartment of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.

Xiaocan JiaDepartment of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.ORCID 0000-0003-0895-2957

Jicun ZhuDepartment of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.

Funding

Henan Provincial Science and Technology Research Project 252102311151Medical Science and Technology Research Project of Henan Province LHGJ20240257

6 · The paper itself

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' (

Indexed as

adverse eventCOPDFAERSfluticasone furoateumeclidiniumvilanterol

Identifiers

PMID41441326

DOI10.3390/pharmacy13060178

PMCPMC12737015

What OpenQuestion holds

Textmetadata

LicenceCC BY

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.