| アブストラクト | BACKGROUND: Direct Oral Anticoagulants (DOACs) have revolutionized the management of thrombotic conditions, providing more predictable and manageable anticoagulation compared to traditional vitamin K antagonists. Despite their success, major bleeding events remain a significant concern. This study aims to assess and compare the haemorrhagic risks associated with various DOACs using data from the FDA's Adverse Event Reporting System (FAERS). METHODS: A retrospective disproportionality analysis of the FAERS database was conducted, covering the period from January 1, 2015, to December 31, 2023. The study focused on adverse bleeding events reported for DOACs. The Proportional Reporting Ratio (PRR) was calculated for each DOAC to identify disproportionate reporting of haemorrhagic events. Major haemorrhagic events were classified as those leading to hospitalization. The analysis also utilized the Medicare Part D dataset to estimate the usage of specific DOACs from 2015 to 2021. RESULTS: A total of 353,188 haemorrhagic events were identified, with 17,236 (4.9%) attributed to DOACs. The PRR for major haemorrhagic events was highest for Edoxaban at 14.1 (95% CI 13.93-14.85), followed by Dabigatran at 4.0 (95% CI 3.81-4.20), Apixaban at 3.53 (95% CI 3.47-3.61), and Rivaroxaban at 2.11 (95% CI 2.05-2.18). Edoxaban also had the highest PRR for cerebral haemorrhages. Medicare data indicated that Apixaban was the most commonly used DOAC (58.3%), followed by Rivaroxaban (34.5%). CONCLUSIONS: Edoxaban shows a significantly higher risk of major and cerebral haemorrhages compared to other DOACs, while Rivaroxaban demonstrates a lower overall risk of haemorrhage. These findings emphasize the need for careful consideration of bleeding risks in DOAC therapy. Continuous post-marketing surveillance is crucial for understanding the safety profiles of DOACs in real-world clinical settings, aiding clinicians and patients in making informed decisions about anticoagulant therapy. |
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| ジャーナル名 | Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association |
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| Pubmed追加日 | 2024/12/7 |
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| 投稿者 | di Biase, Lazzaro; Bonura, Adriano; Pecoraro, Pasquale Maria; Di Lazzaro, Vincenzo |
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| 組織名 | Operative Research Unit of Neurology, Fondazione Policlinico Universitario Campus;Bio-Medico, Via Alvaro del Portillo, 200 - 00128, Roma, Italy; Brain Innovations;Lab, Universita Campus Bio-Medico di Roma, Via Alvaro del Portillo 21, 00128,;Rome, Italy. Electronic address: l.dibiase@policlinicocampus.it.;Bio-Medico, Via Alvaro del Portillo, 200 - 00128, Roma, Italy; Research Unit of;Neurology, Neurophysiology and Neurobiology, Department of Medicine and Surgery,;Universita Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21 - 00128, Roma,;Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39643068/ |
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