| アブストラクト | AIM: Evidence regarding the association between various tumor necrosis factor-alpha (TNF-alpha) inhibitors and cardiovascular adverse events (AEs) is both limited and contradictory. METHODS: A retrospective pharmacovigilance study was conducted using the FDA Adverse Event Reporting System (FAERS) database. Cardiovascular AEs associated with TNF-alpha inhibitors (adalimumab, infliximab, etanercept, golimumab, and certolizumab) were evaluated using a disproportionality analysis. To reduce potential confounders, adjusted ROR and subgroup analyses were performed. RESULTS: After excluding duplicates, 9,817 cardiovascular reports were associated with the five TNF-alpha inhibitors. Only adalimumab had positive signals for myocardial infarction (ROR=1.58, 95%CI=1.51-1.64) and arterial thrombosis (ROR=1.54, 95%CI=1.49-1.58). The remaining four TNF-alpha inhibitors did not show a risk association with any type of cardiovascular event. Further analyses of specific indication subgroups and after adjusting for any confounding factors demonstrated that adalimumab was still significantly associated with cardiovascular events, especially in patients with psoriasis (adjusted ROR=2.16, 95%CI=1.95-2.39). CONCLUSIONS: This study revealed that adalimumab was the only TNF-alpha inhibitor associated with an elevated risk of thrombotic cardiovascular AEs, whereas the other four TNF-alpha inhibitors did not show any risk effect. However, given the limitations of such pharmacovigilance studies, it is necessary to validate these findings in prospective studies in the future. |
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| ジャーナル名 | Journal of atherosclerosis and thrombosis |
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| 投稿日 | 2024/6/13 |
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| 投稿者 | Ma, Junlong; Cai, Jiangfan; Chen, Heng; Feng, Zeying; Yang, Guoping |
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| 組織名 | Center of Clinical Pharmacology, Third Xiangya Hospital, Central South;University.;Hubei Provincial Clinical Research Center for Umbilical Cord Blood Hematopoietic;Stem Cells, Taihe Hospital, Hubei University of Medicine.;Department of Pharmacy, The First Hospital of Changsha. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38866553/ |
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