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Pattern and Impact of Off-label Underdosing of Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation Who are Indicated for Standard Dosing.

非维生素k拮抗剂口服抗凝剂在心房颤动患者中标示外剂量不足的模式和影响。

  • 影响因子:2.86
  • DOI:10.1016/j.amjcard.2020.01.044
  • 作者列表:"Cho MS","Yun JE","Park JJ","Kim YJ","Lee J","Kim H","Park DW","Nam GB
  • 发表时间:2020-05-01
Abstract

:With safety concerns about increasing bleeding, off-label underdosing of non-vitamin K antagonist anticoagulants (NOACs) is common in East Asian patients with atrial fibrillation (AF). We tried to investigate the pattern of NOAC underdosing and associated clinical outcomes in patients with AF who are indicated for standard dosing. Using the Korean National Health Insurance Service database, we evaluated 16,568 patients with a new prescription of NOAC who are indicated for standard NOAC dosing and compared 4,536 patients with warfarin with respect to thromboembolic events (ischemic stroke or systemic embolization), all-cause mortality and major bleeding. Of the 16,568 patients indicated for standard NOAC dosing, 8,549 (51.9%) received off-label underdosing (50.6% rivaroxaban, 53.0% apixaban). During a median follow up of 15.0 months, as compared with warfarin, underdosing of rivaroxaban was associated with lower risks of major thromboembolic events (hazard ratio [HR]: 0.53; 95% confidence interval [CI]: 0.41 to 0.69) and all-cause mortality (HR 0.57, 95% CI: 0.41 to 0.82), and a similar risk of major bleeding (HR 1.10, 95% CI: 0.82 to 1.46). However, underdosing of apixaban was associated with similar risks of major thromboembolic events (HR: 0.90; 95% CI: 0.70 to 1.16), all-cause mortality (HR 0.94, 95 CI: 0.71 to 1.24) and major bleeding (HR 0.84, 95% CI: 0.61 to 1.17). In conclusion, in this Korean population with AF who are indicated for standard NOAC dosing, off-label underdosing is common and its clinical benefit over warfarin was inconsistent according to types of NOAC. Notably, apixaban underdosing provides no benefit in effectiveness compared with warfarin.

摘要

: 考虑到增加出血的安全性问题,非维生素k拮抗剂抗凝剂 (NOACs) 的标签外剂量不足在东亚心房颤动 (AF) 患者中很常见。我们试图研究适用于标准剂量的AF患者的NOAC剂量不足模式和相关临床结局。使用韩国国家健康保险服务数据库,我们评估了16,568例NOAC新处方患者,这些患者适用于标准NOAC剂量,并就血栓栓塞事件 (缺血性卒中或全身性栓塞) 、全因死亡率和大出血对4,536例华法林患者进行了比较.在推荐标准NOAC给药的16,568例患者中,8,549例 (51.9%) 接受了标示外剂量不足 (50.6% 利伐沙班,53.0% 阿哌沙班).在15.0个月的中位随访期间,与华法林相比,利伐沙班未用药与较低的主要血栓栓塞事件风险 (风险比 [HR]: 0.53; 95% 置信区间 [CI]: 0.41至0.69) 和全因死亡率 (HR 0.57,95% CI: 0.41至0.82),和类似的大出血风险 (HR 1.10,95% CI: 0.82 ~ 1.46)。然而,阿哌沙班剂量不足与相似的主要血栓栓塞事件 (HR: 0.90; 95% CI: 0.70 ~ 1.16) 、全因死亡率 (HR 0.94,95 CI: 0.71 ~ 1.24) 和大出血 (HR 0.84,95% CI: 0.61 ~ 1.17) 风险相关.总之,在这一符合标准NOAC剂量的韩国房颤人群中,标示外剂量不足是常见的,根据NOAC的类型,其相对于华法林的临床获益不一致.值得注意的是,与华法林相比,阿哌沙班剂量不足在有效性方面没有获益.

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影响因子:1.41
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