Assessing the impact of dabigatran and warfarin on health-related quality of life: Results from an RE-LY sub-study
Assessing the impact of dabigatran and warfarin on health-related quality of life: Results from an RE-LY sub-study
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DOI：
10.1016/j.ijcard.2013.03.059
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发表时间：
2013-10-03
影响因子：
3.5
通讯作者：
Pooley, J.
中科院分区：
文献类型：
--
作者：
Monz, B. U.;Connolly, S. J.;Pooley, J.
背景：抗凝被推荐用于房颤（AF）患者以预防卒中。维生素K拮抗剂（如华法林）与许多实际限制（频繁抗凝监测、生活方式和饮食限制）相关，这些限制使患者管理复杂化，并可能影响健康相关生活质量（HRQoL）。本研究推导出接受华法林或达比加群酯的AF患者的HRQoL估计值（达比加群酯），一种不需要抗凝监测的新型口服抗凝剂，在一年的稳定治疗期间，即在没有结局事件，如中风或严重bleeding。方法：使用EQ-5D评估HRQoL随时间和治疗之间的变化在基线、3个月和12个月时，在参与RE-LY试验的1435名患者的亚组中进行（效用和视觉疼痛量表（VAS）评分）。RE-LY是一项III期研究，比较了华法林、达比加群150 mg bid和达比加群110 mg bid预防AF患者卒中的安全性和有效性。结果：基线时的效用范围为0.805（达比加群150 mg bid）至0.811（达比加群110 mg bid），在一年的观察期内没有变化。除达比加群150 mg bid组在3个月时的差异外，达比加群组与华法林组之间无统计学显著性差异。同样，组内或组间VAS评分差异无统计学意义。结论：在一年的过程中，所有抗凝患者无结局事件（e. G.中风或严重的眼睑炎）的HRQoL稳定。达比加群和华法林之间的评分相当，鉴于已知华法林治疗的复杂性，这是意料之外的。(C)由Elsevier爱尔兰有限公司出版。
d Background: Anticoagulation is recommended in patientswith atrial fibrillation (AF) to prevent strokes. Vitamin K antagonists, such as warfarin, are associated with numerous practical limitations-frequent anticoagulation monitoring, lifestyle and dietary restrictions-that complicate patient management and may impact healthrelated quality of life (HRQoL). This study derived HRQoL estimates for AF patients receiving warfarin or dabigatran etexilate (dabigatran), a new oral anticoagulant not requiring anticoagulation monitoring, during one year of stable treatment, i.e. in the absence of outcome events, such as strokes or major bleedings.Methods: Changes in HRQoL over time and between treatments were assessed using the EQ-5D (utility and Visual Analogue Scale (VAS) scores) at baseline, 3 and 12 months in a sub-group of 1435 patients participating in the RE-LY trial. RE-LY was a phase III study that compared the safety and efficacy of warfarin, dabigatran 150 mg bid and dabigatran 110 mg bid for stroke prevention in patients with AF.Results: Utilities ranged from 0.805 (dabigatran 150 mg bid) to 0.811 (dabigatran 110 mg bid) at baseline, and did not change over the one year observation period. No differences between the dabigatran groups and warfarin were statistically significant except for the dabigatran 150 mg bid group at 3 months. Similarly, none of the within-group or between-group differences in VAS scores were statistically significant.Conclusions: Over the course of one year, all anticoagulated patients without outcome events (e. g. strokes or major bleedings) had stable HRQoL. Scores between dabigatran and warfarin were comparable, which was unexpected given the known complexities of warfarin treatment. (C) 2013 Published by Elsevier Ireland Ltd.