ID | 119463 |
Title Alternative | PDE5 Inhibitors & Aortic Diseases
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Author |
Miyata, Koji
Tokushima University
Izawa-Ishizawa, Yuki
Tokushima University|Taoka Hospital
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Niimura, Takahiro
Tokushima University
Tokushima University Educator and Researcher Directory
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Hamano, Hirofumi
Tokushima University|Okayama University
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Aizawa, Fuka
Tokushima University
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Kawada, Kei
Tokushima University
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Keywords | PDE5 inhibitors
Aneurysm
Arterial dissection
Pharmacovigilance
Adverse event
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Content Type |
Journal Article
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Description | Aneurysm and arterial dissection have been reported as adverse drug events, associated with angiogenesis inhibitors and fluoroquinolones. Specifically, several cases of severe arterial disease following cGMP-specific phosphodiesterase type 5 (PDE5) inhibitors usage have recently been reported. It is necessary to ascertain the risks of serious adverse events caused by PDE5 inhibitors. We aimed to evaluate the association of aneurysm and artery dissection with PDE5 inhibitors using VigiBase, which is a World Health Organization database of spontaneously reported adverse events, for explorative hypothesis-generating analysis. We performed disproportionality analysis using a dataset from inception in 1967 to December 2022 and calculated reporting odds ratios (ROR) between PDE5 inhibitors and arterial diseases. We extracted 195,839 reports on PDE5 inhibitors with 254 reports of arterial disease as adverse events from VigiBase. Disproportionality analysis showed disproportional signals for PDE5 inhibitors (ROR, 2.30 ; 95% confidence intervals, 2.04-2.61) ; disproportional signals were detected in analyses restricting the lesion site to the aorta or cerebral arteries. From stratified analysis, disproportional signals were noted in females, as well as males, generally recognized as a risk factor for artery diseases. This real-world data analysis suggests that PDE5 inhibitors may play a role in the development of lethal arterial disease.
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Journal Title |
The Journal of Medical Investigation
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ISSN | 13496867
13431420
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NCID | AA11166929
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Publisher | Tokushima University Faculty of Medicine
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Volume | 71
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Issue | 1-2
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Start Page | 134
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End Page | 140
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Sort Key | 134
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Published Date | 2024-02
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DOI (Published Version) | |
URL ( Publisher's Version ) | |
FullText File | |
language |
eng
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TextVersion |
Publisher
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departments |
Medical Sciences
University Hospital
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