Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008-2015): A cross-national drug utilization study
Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008-2015): A cross-national drug utilization study
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DOI：
10.1111/bcp.14071
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发表时间：
2019-11-01
影响因子：
3.4
通讯作者：
Gardarsdottir, Helga
中科院分区：
文献类型：
--
作者：
Ibanez, Luisa;Sabate, Monica;Gardarsdottir, Helga
目的评估非瓣膜性心房颤动患者直接口服抗凝药物(DOAC)的发生率，并描述代表6个欧洲国家的8个欧洲医疗保健数据库的使用者和治疗特点。方法2008年1月至2015年12月，采用纵向药物利用研究方法。采用了一种通用的协议方法。进行了年度经期发病率和按年龄和性别的直接标准化。评估了与年龄变化和肾功能变化相关的剂量调整以及潜在相互作用药物的伴随使用。结果共查出新发DOAC使用者186405人，年龄18岁。达比加兰和利伐沙班的标化发病率分别为1.93-2.60和0.11-8.71人/万(2011-2015年)，阿匹沙班的标化发病率为0.01-8.12人/万(2012-2015)。2015年，西班牙SIDIAP和丹麦DNR的DOAC发病率分别为9/10000到28/10000。不同的数据库在人口覆盖率方面存在差异。只有1个数据库包括总参考人口(DNR)，而其他数据库被视为具有人口代表性的样本(CPRD、BIFAP、SIDIAP、EGB、Mondriaan)。它们在药物数据来源的类型(管理、临床)上也各不相同。剂量调整范围从BIFAP(西班牙)的4.6%到EGB(法国)的15.6%。合并使用相互作用药物的比例在16.4%(SIDIAP)至70.5%(EGb)之间。心血管并发症的发生率从蒙德里安(荷兰)的25.4%到AOK Nordwest(德国)的82.9%不等。结论总体上，阿皮沙班和利伐沙班在研究期间增加了其使用量，而达比卡特兰减少了。患者的特征存在差异，如合并症、潜在的相互作用的药物和剂量调整。(EMA/2015/27/PH)。
Aims To estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries. Methods Longitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed. Results A total of 186 405 new DOAC users (age >= 18 years) were identified. Standardized incidences varied from 1.93-2.60 and 0.11-8.71 users/10 000 (2011-2015) for dabigatran and rivaroxaban, respectively, and from 0.01-8.12 users/10 000 (2012-2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany). Conclusion Overall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH).