Università degli studi di Padova, Padova, Italia.
Analytica-Laser, a Certara company, Londra, United Kingdom.
PLoS One. 2019 Oct 7;14(10):e0222762. doi: 10.1371/journal.pone.0222762. eCollection 2019.
Oral anticoagulant therapy (VKA) is nowadays the mainstay of treatment in primary and secondary stroke prevention in patients with atrial fibrillation. Given the limited risk-benefit ratio of vitamin K antagonists, pharmacological research has been directed towards the development of products that could overcome these limits, new oral anticoagulants were recently introduced: dabigatran, rivaroxaban, apixaban, and edoxaban.
Scope of the present study was to examine patterns of use, effectiveness, safety and mean annual cost per patient of anticoagulant treatment for non-valvular AF in real clinical practice.
A retrospective observational cohort study, by using administrative databases (drugs, hospitalizations, clinical visits, lab tests, population registry), was conducted in the Local Health Unit (LHU) of Treviso, Italy, from January 1, 2012 to December 31, 2016.
5597 subjects were selected, 2171 of which satisfied all inclusion criteria. In particular 1355 patients were treated with VKA, 577 patients were treated with NOAC, and 239 patients were treated initially with VKA and subsequently switched to NOAC (switch group). NOAC treatment showed to be superior to VKA and this superiority was statistically significant on both end-points: patients in the NOAC group reported less cardiovascular events (9,9%) and less bleeding episodes (5,5%) versus VKA patients (14,6% and 11,4%; p<,0001 and p = 0,0049, respectively). The mean cost per patient per year was respectively € 1323,9 for patients treated with NOAC versus € 1003,3 for patients treated with VKA. Cost difference appears to be largely driven by drug cost (€ 767,9 for NOAC versus € 17,7 for VKA patients) and by specialist visits and laboratory tests (€ 318,4 for NOAC versus € 733,4 for VKA patients).
In this retrospective real-world study treatment with NOAC showed to be associated with significant reductions of CV events and bleeding events compared to VKA use, albeit at a higher NHS' direct cost per patient/year, mainly due to higher drug therapy cost.
目前，口服抗凝剂治疗（VKA）是房颤患者一级和二级卒中预防的主要治疗方法。鉴于维生素 K 拮抗剂的风险效益比有限，药物研究一直致力于开发能够克服这些限制的产品，最近推出了新型口服抗凝剂：达比加群、利伐沙班、阿哌沙班和依度沙班。
本研究旨在考察新型口服抗凝剂在真实临床实践中用于非瓣膜性房颤抗凝治疗的使用模式、疗效、安全性和每位患者的平均年度治疗费用。
采用回顾性观察性队列研究，使用行政数据库（药物、住院、临床就诊、实验室检查、人群登记），于 2012 年 1 月 1 日至 2016 年 12 月 31 日在意大利特雷维索地方卫生局进行。
共纳入 5597 例患者，其中 2171 例符合所有纳入标准。其中，1355 例患者接受 VKA 治疗，577 例患者接受 NOAC 治疗，239 例患者初始接受 VKA 治疗，随后转换为 NOAC（转换组）。NOAC 治疗优于 VKA，在两个终点上均具有统计学意义：NOAC 组患者报告的心血管事件（9.9%）和出血事件（5.5%）少于 VKA 组（14.6%和 11.4%；p<0.0001 和 p=0.0049）。NOAC 组和 VKA 组患者的年人均治疗费用分别为 1323.9 欧元和 1003.3 欧元。成本差异主要归因于药物成本（NOAC 组 767.9 欧元，VKA 组 17.7 欧元）和专科就诊和实验室检查（NOAC 组 318.4 欧元，VKA 组 733.4 欧元）。
在这项回顾性真实世界研究中，与 VKA 治疗相比，NOAC 治疗与心血管事件和出血事件的显著减少相关，尽管每位患者/年的 NHS 直接成本较高，主要是由于药物治疗费用较高。
