Immunomodulators Associated With Atrial Fibrillation: A Vigibase Disproportionality Analysis and

07 Apr 20265 min read0 viewsJournal Feed

GIST (Key Takeaways)

Objectives Growing evidence exists about the pivotal role of immune mechanisms in the physiopathology of atrial fibrillation (AF). Drugs that modulate the immune system (immunomodulators) may contribute to the development of AF. We aimed to identify immunomodulators that are associated with AF to better define their safety profile, and elucidating their mechanisms of action could yield novel insights into AF's immune physiopathology.
Design A descriptive and disproportionality analysis of claims data. Settings World pharmacovigilance database VigiBase until 1 March 2025. Primary and secondary ouctomes First, we ascertained the association of immunomodulators with AF over-reporting with a disproportionality analysis evaluating the multivariable-adjusted reporting odds ratio (aROR) for AF reporting performed for 141 immunomodulators in VigiBase.
Then, a literature review was done to explore the underlying mechanisms of AF through immunomodulator mechanisms. Results A total of 6 148 556 reports encompassing at least one of the 141 immunomodulators were identified in Vigibase. Our primary analysis revealed 20 immunomodulators associated with AF over-reporting.

Clinical Editorial

BMJ Open published a clinical update in Research Highlights on 07 Apr 2026.

The item focuses on Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review.

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