Mocini David, Di Fusco Stefania Angela, De Luca Leonardo, Caldarola Pasquale, Cipriani Manlio, Corda Marco, Di Lenarda Andrea, De Nardo Alfredo, Francese Giuseppina Maura, Napoletano Cosimo, Navazio Alessandro, Riccio Carmine, Roncon Loris, Tizzani Emanuele, Urbinati Stefano, Valente Serafina, Gulizia Michele Massimo, Gabrielli Domenico, Oliva Fabrizio, Colivicchi Furio
U.O.C. Cardiologia Clinica e Riabilitativa, Presidio Ospedaliero San Filippo Neri - ASL Roma 1, Roma.
U.O.C. Cardiologia, Dipartimento Cardio-Toraco-Vascolare, Azienda Ospedaliera San Camillo Forlanini, Roma.
G Ital Cardiol (Rome). 2021 Dec;22(12):1024-1033. doi: 10.1714/3698.36882.
The prescription appropriateness of direct oral anticoagulants (DOACs [dabigatran, rivaroxaban, apixaban, and edoxaban]) is carefully regulated, taking into account the criteria established in phase III trials and listed in the summary of the product characteristics of the four DOACs. In clinical practice, prescriptions are not always in compliance with established indications. In particular, the use of doses lower than those recommended in drug data sheets is relatively frequent. Literature data show that the inappropriate prescription of DOAC doses causes drug underexposure and an up to three-fold increase in the risk of stroke/transient ischemic attack, systemic thromboembolism, and hospitalizations. Possible causes of the deviation between the dose that should be prescribed and that actually employed may include erroneous prescriptions, an overstated bleeding risk perception, and the presence of frail patients, who were not included in pivotal trials. For these reasons, we summarize DOAC indications and contraindications and suggest the appropriate use of DOACs in common clinical scenarios, in accordance with what international guidelines and national and international health regulatory agencies recommend.
直接口服抗凝剂（DOACs[达比加群、利伐沙班、阿哌沙班和依度沙班]）的处方适宜性受到严格监管，需考虑III期试验中确立并在这四种DOACs的产品特性摘要中列出的标准。在临床实践中，处方并不总是符合既定适应症。特别是，使用低于药品说明书中推荐剂量的情况相对常见。文献数据表明，DOAC剂量的不适当处方会导致药物暴露不足，并使中风/短暂性脑缺血发作、全身性血栓栓塞和住院风险增加多达三倍。应处方剂量与实际使用剂量之间出现偏差的可能原因包括错误处方、对出血风险的高估以及关键试验中未纳入的体弱患者的存在。出于这些原因，我们根据国际指南以及国家和国际卫生监管机构的建议，总结了DOAC的适应症和禁忌症，并建议在常见临床场景中合理使用DOACs。
