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比利时和荷兰接受依度沙班治疗的房颤患者特征:ETNA-AF-Europe研究的见解

Characteristics of patients with atrial fibrillation prescribed edoxaban in Belgium and the Netherlands: insights from the ETNA-AF-Europe study.

作者信息

de Vries T A C, Hemels M E W, Cools F, Crijns H J G M, Yperzeele L, Vanacker P, Blankoff I, Lancellotti P, Mairesse G H, de Veer A, Casado Arroyo R, Catez E, de Pauw M, Vanassche T, de Asmundis C, Kirchhof P, De Caterina R, de Groot J R

机构信息

Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.

Department of Cardiology, Amsterdam Medical Centres/University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Neth Heart J. 2021 Mar;29(3):158-167. doi: 10.1007/s12471-020-01518-7. Epub 2021 Jan 7.

Abstract

BACKGROUND

Studies on the use of non-vitamin K antagonist oral anticoagulants in unselected patients with atrial fibrillation (AF) show that clinical characteristics and dosing practices differ per region, but lack data on edoxaban.

METHODS

With data from Edoxaban Treatment in routiNe clinical prActice for patients with AF in Europe (ETNA-AF-Europe), a large prospective observational study, we compared clinical characteristics (including the dose reduction criteria for edoxaban: creatinine clearance 15-50 ml/min, weight ≤60 kg, and/or use of strong p‑glycoprotein inhibitors) of patients from Belgium and the Netherlands (BeNe) with those from other European countries (OEC).

RESULTS

Of all 13,639 patients in ETNA-AF-Europe, 2579 were from BeNe. BeNe patients were younger than OEC patients (mean age: 72.3 vs 73.9 years), and had lower CHADS-VASc (mean: 2.8 vs 3.2) and HAS-BLED scores (mean: 2.4 vs 2.6). Patients from BeNe less often had hypertension (61.6% vs 80.4%), and/or diabetes mellitus (17.3% vs 23.1%) than patients from OEC. Moreover, relatively fewer patients in BeNe were prescribed the reduced dose of 30 mg edoxaban (14.8%) than in OEC (25.4%). Overall, edoxaban was dosed according to label in 83.1% of patients. Yet, 30 mg edoxaban was prescribed in the absence of any dose reduction criteria in 36.9% of 30 mg users (5.5% of all patients) in BeNe compared with 35.5% (9.0% of all patients) in OEC.

CONCLUSION

There were several notable differences between BeNe and OEC regarding clinical characteristics and dosing practices in patients prescribed edoxaban, which are relevant for the local implementation of dose evaluation and optimisation.

TRIAL REGISTRATION

NCT02944019; Date of registration 24 October 2016.

摘要

背景

对未选择的心房颤动(AF)患者使用非维生素K拮抗剂口服抗凝剂的研究表明,临床特征和给药方法因地区而异,但缺乏关于依度沙班的数据。

方法

利用来自欧洲AF患者常规临床实践中的依度沙班治疗(ETNA-AF-Europe)这一大型前瞻性观察性研究的数据,我们比较了比利时和荷兰(比荷卢)患者与其他欧洲国家(OEC)患者的临床特征(包括依度沙班的剂量降低标准:肌酐清除率15 - 50ml/min、体重≤60kg和/或使用强效P-糖蛋白抑制剂)。

结果

在ETNA-AF-Europe的所有13639名患者中,2579名来自比荷卢。比荷卢患者比OEC患者更年轻(平均年龄:72.3岁对73.9岁),且CHADS-VASc评分(平均:2.8对3.2)和HAS-BLED评分(平均:2.4对2.6)更低。与OEC患者相比,比荷卢患者患高血压(61.6%对80.4%)和/或糖尿病(17.3%对23.1%)的情况较少。此外,比荷卢接受30mg依度沙班减量剂量治疗的患者(14.8%)相对少于OEC(25.4%)。总体而言,83.1%的患者依依度沙班标签给药。然而,在比荷卢,36.9%的30mg使用者(占所有患者的5.5%)在没有任何剂量降低标准的情况下被开具30mg依度沙班,而在OEC中这一比例为35.5%(占所有患者的9.0%)。

结论

在接受依度沙班治疗的患者中,比荷卢和OEC在临床特征和给药方法方面存在一些显著差异,这与当地剂量评估和优化的实施相关。

试验注册

NCT02944019;注册日期2016年10月24日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1570/7904979/7308a3336a99/12471_2020_1518_Fig1_HTML.jpg

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