Lavalle Carlo, Mariani Marco Valerio, Piro Agostino, Magnocavallo Michele, Vetta Giampaolo, Trivigno Sara, Forleo Giovanni Battista, Della Rocca Domenico Giovanni, Uguccioni Massimo, Russo Vincenzo, Summaria Francesco, Di Lullo Luca
Department of Cardiovascular, Respiratory, Nephrological, Aenesthesiological and Geriatric Sciences, "Sapienza" University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.
Department of Cardiology, ASST-Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, 20157 Milan, Italy.
J Clin Med. 2022 Jun 4;11(11):3207. doi: 10.3390/jcm11113207.
Direct oral anticoagulants (DOACs) are the preferred anticoagulant drugs for the prevention of atrial fibrillation (AF)-related thromboembolic complications and for the treatment and the prevention of recurrences of venous thromboembolism (VTE). The evaluation of self-reported adverse drug reactions (ADRs) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision making.
To assess the safety profile of DOACs by analyzing ADR rates in the real-world Italian scenario.
Post-marketing surveillance data recorded by the National Pharmacovigilance Network were retrieved for the time period 2017-2021 from the AIFA online site. The following data were collected for each DOAC: total ADR number, serious ADR number, gastrointestinal (GI) ADR, intracranial hemorrhage events (ICH ADR), and more frequently reported ADR for the study year. The safety profile was expressed by the risk index (RI).
Rivaroxaban use was associated with consistent and stable low rates of serious ADR, GI ADR, and ICH ADR across the 5-year study period. Rivaroxaban and apixaban showed the lowest RI for serious ADR and GI ADR, while rivaroxaban use was associated with significantly lower ICH events as compared to apixaban. Dabigatran was related to the highest RIs for every ADR class, in particular GI ADRs.
DOACs presented an acceptable safety profile in the current post-market analysis. However, rivaroxaban and apixaban were associated with more favorable safety profiles as compared to dabigatran, while rivaroxaban provoked statistically significantly fewer ICH events as compared to apixaban.
直接口服抗凝剂（DOACs）是预防心房颤动（AF）相关血栓栓塞并发症以及治疗和预防静脉血栓栓塞（VTE）复发的首选抗凝药物。从意大利药品管理局（AIFA）药物警戒数据库等药品监管机构的数据库中获取的自我报告药物不良反应（ADR）评估是指导决策的一种新辅助手段。
通过分析意大利真实场景中的ADR发生率来评估DOACs的安全性。
从AIFA在线网站检索国家药物警戒网络在2017 - 2021年期间记录的上市后监测数据。为每种DOAC收集以下数据：ADR总数、严重ADR数、胃肠道（GI）ADR、颅内出血事件（ICH ADR）以及研究年度中报告更频繁的ADR。安全性通过风险指数（RI）表示。
在5年研究期间，利伐沙班的使用与严重ADR、GI ADR和ICH ADR的持续稳定低发生率相关。利伐沙班和阿哌沙班在严重ADR和GI ADR方面显示出最低的RI，而与阿哌沙班相比，利伐沙班的使用与显著更低的ICH事件相关。达比加群在每个ADR类别中，尤其是GI ADR方面，与最高的RI相关。
在当前的上市后分析中，DOACs呈现出可接受的安全性。然而，与达比加群相比，利伐沙班和阿哌沙班具有更有利的安全性，而与阿哌沙班相比，利伐沙班引发的ICH事件在统计学上显著更少。
