| アブストラクト | PURPOSE: To analyze cardiovascular and cerebrovascular adverse events (ADRs) after intravitreal anti-vascular endothelial growth factor (VEGF; aflibercept, bevacizumab, brolucizumab, and ranibizumab) treatment. SUBJECTS: VigiBase, a World Health Organization (WHO) global safety report database DESIGN: Pharmacovigilance study METHODS: The individual-case-safety reports (ICSR) of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment were compared with those reported in the full database. From 2004 to 2023, 23,129 ADRs after intravitreal anti-VEGF therapy and 25,015,132 ADRs associated with any drug (full database). MAIN OUTCOME MEASURES: The reporting odds ratio (ROR) and information components (IC) were calculated, and the 95% lower credibility interval endpoint of the information component (IC(025)) was used for disproportionate Bayesian reporting. Inter-drug comparisons were performed using the ratio of odd ratio (rOR). RESULTS: Compared with the full database, anti-VEGFs were associated with an increased reporting of myocardial infarction (IC(025) 0.75; ROR: 1.78 [95% CI 1.70-1.86]), angina pectoris (IC(025) 0.53; ROR: 1.61 [95% CI 1.47-1.77]), arrythemias including atrial fibrillation, atrial flutter, ventricular fibrillation, supraventricular tachycardia (all IC(025) >0(,) ROR>1), hypertension (IC(025) 2.22; ROR: 4.91 [95% CI 4.82-5.01]), and hypertensive crisis (IC(025) 1.97; ROR: 4.49 [95% CI 4.07-4.97]). Moreover, anti-VEGFs were associated with a higher reporting of cerebrovascular ADRs such as cerebral infarction (IC(025) 4.34; ROR: 23.19 [95% CI 22.10-24.34]), carotid artery stenosis (IC(025) 1.85; ROR: 5.24 [95% CI 3.98-6.89]), cerebral hemorrhage (IC(025) 2.29; ROR: 5.38 [95% CI 5.03-5.76]), and subarachnoid hemorrhage (IC(025) 1.98; ROR: 4.81 [95% CI 4.14-5.6]). Inter-drug comparison indicated that compared to ranibizumab, patients with aflibercept showed overall under-reporting of cardiovascular and cerebrovascular ADRs such as myocardial infarction (rOR 0.55 [95% CI 0.49-0.52]), atrial fibrillation (rOR 0.28 [95% CI 0.23-0.35]), cerebrovascular accident (rOR, 0.15 [95% CI 0.14-0.17]), and cerebral hemorrhage (rOR, 0.51 [95% CI 0.40-0.65]). CONCLUSIONS: In this pharmacovigilance case-noncase study, significantly increased reporting of cardiovascular and cerebrovascular ADRs were identified after intravitreal anti-VEGF treatment. While ranibizumab may exhibit superior systemic safety regarding its biological characteristics, it is crucial not to overlook the occurrence of cardiovascular and cerebrovascular ADRs considering its higher reporting rate than bevacizumab or aflibercept. |
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| ジャーナル名 | Ophthalmology |
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| 投稿日 | 2024/7/15 |
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| 投稿者 | Yang, Jee Myung; Jung, Se Yong; Kim, Min Seo; Lee, Seung Won; Yon, Dong Keon; Shin, Jae Il; Lee, Joo Yong |
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| 組織名 | Department of Ophthalmology, Asan Medical Center, University of Ulsan College of;Medicine, Seoul, Korea.;Department of Pediatrics, Yonsei University College of Medicine, Seoul, South;Korea.;Medical and Population Genetics and Cardiovascular Disease Initiative, Broad;Institute of MIT and Harvard, Cambridge, MA, USA.;Department of Precision Medicine, Sungkyunkwan University School of Medicine,;Suwon, South Korea.;Center for Digital Health, Medical Science Research Institute, Kyung Hee;University Medical Center, Kyung Hee University College of Medicine, Seoul, South;Korea. Electronic address: yonkkang@gmail.com.;Korea. Electronic address: shinji@yuhs.ac.;Medicine, Seoul, Korea. Electronic address: ophthalmo@amc.seoul.kr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39004231/ |
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