ArticleBasic & clinical pharmacology & toxicology2025
High Throughput Pharmacovigilance Screening for Roflumilast Adverse Effects in Real-World Settings: A Sequence Symmetry Analysis.
Article in Basic & clinical pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Prescribing Cascades: An Umbrella Review and Updated Systematic Review.Drugs & aging · 2026Pooled it
- Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRoflumilast is an add-on therapy for COPD following exacerbations, but real-world safety data in the United States are limited.
objectiveThis study aimed to identify safety signals associated with roflumilast initiation through a high-throughput signal detection algorithm.
methodsUsing sequence symmetry analysis (SSA), we analysed Marketscan databases for new roflumilast users (2011-2021). We screened for adverse effects across 211 therapeutic classes within 365 days of initiation. Sensitivity analyses were conducted by sex, age and observation period. Crude and adjusted sequence ratios (cSR and aSR) were reported with 95% confidence intervals (CIs).
resultsAmong 11 091 patients (53% aged 65+, 52% female), 32 safety signals were identified. Strong associations were observed with antithyroid agents (aSR, 4.18; 95% CI: 1.66-11.95), parathyroid hormones (aSR, 3.09; 95% CI: 1.56-6.44), haematopoietic agents (aSR, 2.55; 95% CI: 1.07-6.49) and meglitinides (aSR, 2.37; 95% CI: 1.15-5.35). While many signals aligned with prior clinical trial data, novel associations with antithyroid and parathyroid agents were discovered.
conclusionIn our study, we detected 32 safety signals for roflumilast, including notable associations with antithyroid agents and parathyroid hormones. Future investigations using more robust study designs are warranted to evaluate those signals.
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Registered trials
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 Socratic graph.