Seelig J, Trinks-Roerdink E M, Chu G, Pisters R, Theunissen L J H J, Trines S A, Pos L, Kirchhof C J H J, de Jong S F A M S, den Hartog F R, van Alem A P, Polak P E, Tieleman R G, van der Voort P H, Lenderink T, Otten A M, de Jong J S S G, Gu Y L, Luermans J G L M, Kruip M J H A, Timmer S A J, de Vries T A C, Cate H Ten, Geersing G J, Rutten F H, Huisman M V, Hemels M E W
Department of Cardiology, Hospital Rijnstate, Rijnstate, Arnhem, the Netherlands.
Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, the Netherlands.
Eur Heart J Open. 2022 Mar 29;2(3):oeac022. doi: 10.1093/ehjopen/oeac022. eCollection 2022 May.
To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients.
In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m, 0.96-1.00).
In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.
评估荷兰新诊断房颤患者非维生素K口服抗凝药（NOAC）超说明书用药的程度及决定因素。
在荷兰房颤注册研究中，前瞻性纳入新诊断房颤（<6个月）患者。使用欧洲药品管理局的标签评估NOAC用药的标签依从性。通过多变量逻辑回归分析探索与超说明书用药相关的因素。2018年7月至2020年11月，共登记4500例患者。平均年龄为69.6±10.5岁，女性占41.5%。在3252例可评估NOAC标签依从性的患者中，分别有4.2%和2.4%出现用药不足和用药过量。在2916例（89.7%）有NOAC全剂量推荐的患者中，4.6%用药不足，各NOAC之间分布相似。独立决定因素（95%置信区间）为年龄较大[比值比（OR）：每年1.01，1.01 - 1.02]、肾功能较低（OR：每毫升/分钟/1.73平方米0.96，0.92 - 0.98）、体重较低（OR：每千克0.98，0.97 - 1.00）、活动性恶性肿瘤（OR：2.46，1.19 - 5.09）、贫血（OR：1.73，1.08 - 2.76）以及同时使用抗血小板药物（OR：4.93，2.57 - 9.46）。在336例（10.3%）有NOAC减量推荐的患者中，22.9%用药过量，最常见于利伐沙班。独立决定因素为年龄较小（OR：每年0.92，0.88 - 0.96）和肾功能较低（OR：每毫升/分钟/1.73平方米0.98，0.96 - 1.00）。
在荷兰新诊断的房颤患者中，仅6.6%的患者存在NOAC超说明书用药情况，最常见的是用药不足。在本研究中，超说明书用药的决定因素为年龄、肾功能、体重、贫血、活动性恶性肿瘤以及同时使用抗血小板药物。
