Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI #x3c;1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.
Cardiorenal Med

中文翻译：

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在意大利实际使用直接口服抗凝剂期间的药物不良反应：基于意大利国家药物警戒网络数据的更新。

背景：临床实践中直接口服抗凝剂 (DOAC) 的可用性改变了为患者提供的预防和治疗血栓栓塞的医疗保健。安全性和有效性数据指导临床医生选择所用药物。迄今为止，没有从头对头试验中比较不同 DOAC 的安全性和有效性的证据；信息主要来自一些荟萃分析和现实生活研究。这些研究的结论不一致且不令人满意。自我报告的药物不良反应 (ADR) 评估可从药物监管机构的数据库中获得，例如意大利药物管理局 (AIFA) 药物警戒数据库，这是指导决策的一种新辅助手段。客观的：在意大利的日常临床实践中使用先前描述的风险指数 (RI) 分析潜在的 DOAC 疑似 ADR。方法：检索国家药物警戒网络数据库（来自 AIFA 网站）以检索 2013 年至 2018 年发生的与口服抗凝剂相关的所有 ADR 信息。计算每种药物的 ADR RI，其中 RI = 1 表示平衡每个 DOAC 的 ADR 份额百分比和市场份额百分比之间；RI #x3c;1 表示 ADR 率低于市场份额率（更安全的 DOAC）。考虑了以下 DOAC 分子：达比加群、利伐沙班、阿哌沙班和依度沙班。结果：结果表明，利伐沙班是目前意大利可用的 4 种分子中 RI 最低的 DOAC。结论：基于 RI，我们将利伐沙班确定为具有最佳安全性的 DOAC。
心肾医学