Monz B U, Connolly S J, Korhonen M, Noack H, Pooley J
Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.
Int J Cardiol. 2013 Oct 3;168(3):2540-7. doi: 10.1016/j.ijcard.2013.03.059. Epub 2013 May 8.
Anticoagulation is recommended in patients with 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 health-related 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.
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.
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.
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.
对于心房颤动（AF）患者，推荐使用抗凝治疗以预防中风。维生素K拮抗剂，如华法林，存在诸多实际限制——频繁的抗凝监测、生活方式及饮食限制——这些使得患者管理变得复杂，并可能影响健康相关生活质量（HRQoL）。本研究得出了在稳定治疗一年期间（即无中风或大出血等结局事件）接受华法林或达比加群酯（达比加群）（一种无需抗凝监测的新型口服抗凝剂）治疗的AF患者的HRQoL估计值。
在参与RE-LY试验的1435名患者的亚组中，于基线、3个月和12个月时使用EQ-5D（效用和视觉模拟量表（VAS）评分）评估HRQoL随时间的变化以及不同治疗之间的差异。RE-LY是一项III期研究，比较了华法林、每日两次服用150mg达比加群和每日两次服用110mg达比加群预防AF患者中风的安全性和有效性。
基线时效用值范围为0.805（每日两次服用150mg达比加群）至0.811（每日两次服用110mg达比加群），在一年观察期内未发生变化。除3个月时的每日两次服用150mg达比加群组外，达比加群组与华法林组之间的差异无统计学意义。同样，VAS评分的组内或组间差异均无统计学意义。
在一年期间，所有无结局事件（如中风或大出血）的抗凝患者的HRQoL保持稳定。达比加群和华法林之间的评分相当，鉴于已知的华法林治疗复杂性，这一结果出人意料。
