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 CHA2DS2-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.

译文

背景:未经选择的房颤(AF)患者使用非维生素K拮抗剂口服抗凝剂的研究表明,每个地区的临床特征和给药方法不同,但缺乏关于edoxaban的数据。
方法:根据一项大型前瞻性观察研究的欧洲房颤患者常规临床实践中的Edoxaban治疗数据(ETNA-AF-Europe),我们比较了临床特征(包括edoxaban的剂量降低标准:肌酐清除率15-50ml / min,体重≤60kg和/或使用比利时和荷兰(BeNe)以及其他欧洲国家(OEC)的患者。
结果:在欧洲ETNA-AF地区的全部13,639名患者中,有2579名来自BeNe。 BeNe患者比OEC患者年轻(平均年龄:72.3 vs 73.9岁),且CHA2DS2-VASc(平均:2.8 vs 3.2)和HAS-BLED分数较低(平均:2.4 vs.2.6)。与来自OEC的患者相比,来自BeNe的患者患高血压的比例更低(分别为61.6%和80.4%)和/或糖尿病(分别为17.3%和23.1%)。此外,相对于OEC(25.4%),服用BeNe减少剂量的30mg edoxaban(14.8%)的患者相对较少。总体而言,依多沙班按标签服用的剂量占83.1%的患者的剂量。然而,在没有任何降低剂量标准的情况下,BeNe的30mg使用者中有36.9%(占所有患者的5.5%)开具了edoxaban处方,而在OEC中为35.5%(占所有患者的9.0%)。
结论:BeNe和OEC在处方依多沙班患者的临床特征和给药方式方面存在显着差异,这与局部实施剂量评估和优化有关。
试用注册:NCT02944019;注册日期2016年10月24日。

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