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在英国,达比加群酯与华法林相比用于急性静脉血栓栓塞症治疗及延长抗凝治疗的成本效益分析

The cost-utility of dabigatran etexilate compared with warfarin in treatment and extended anticoagulation of acute VTE in the UK.

作者信息

Jugrin Anamaria Vera, Ustyugova Anastasia, Urbich Michael, Lamotte Mark, Sunderland Tom

机构信息

Mark Lamotte, Medialaan 38, 1800 Vilvoorde, Belgium, Tel.: +32 2 627 3318, E-mail:

出版信息

Thromb Haemost. 2015 Oct;114(4):778-92. doi: 10.1160/TH14-12-1027. Epub 2015 Aug 13.

Abstract

The relative efficacy and safety of dabigatran etexilate and warfarin have been evaluated in two head-to-head, phase III, treatment of acute venous thromboembolism (VTE) trials, and one extended prophylaxis trial, in patients with high risk of recurrent VTE. Dabigatran etexilate demonstrated similar efficacy to warfarin, and was associated with a reduced risk of major or clinically relevant bleeds. Based on results of these trials, and real-life disease prognosis following discontinuation of anticoagulation treatment, we evaluated the cost-utility of dabigatran etexilate compared with warfarin in six months anticoagulation, and in extended, up to 24 months anticoagulation, in patients with acute VTE, acute deep-vein thrombosis (DVT) or acute, symptomatic, pulmonary embolism (PE). Costs were analysed from the perspective of the National Health Services (NHS) and Public Social Services (PSS) in England and Wales. Outcomes were quantified in quality-adjusted life years (QALY). The estimated incremental, lifetime cost/QALY gain following acute, symptomatic VTE (DVT or PE) was £1,252/QALY when dabigatran etexilate or warfarin were administered for up to six months treatment. In treatment of acute, symptomatic PE and in DVT respective ratios were £1,767/QALY and £1,075/QALY. In extended, up to 24 months anticoagulation, dabigatran etexilate projected costs/QALY of £8,242/QALY, when compared with warfarin. Results obtained herein were robust across a number of sensitivity analyses and suggest dabigatran etexilate to be a cost-effective alternative to current standard of care when evaluated in six months treatment and in extended anticoagulation following acute VTE (DVT and/or PE).

摘要

在两项针对复发性静脉血栓栓塞(VTE)高风险患者的直接比较的III期急性VTE治疗试验以及一项延长预防试验中,已对达比加群酯与华法林的相对疗效和安全性进行了评估。达比加群酯显示出与华法林相似的疗效,并且与严重或临床相关出血风险降低相关。基于这些试验的结果以及抗凝治疗停药后的实际疾病预后,我们评估了达比加群酯与华法林相比在急性VTE、急性深静脉血栓形成(DVT)或急性症状性肺栓塞(PE)患者中进行6个月抗凝以及延长至24个月抗凝的成本效益。成本是从英格兰和威尔士的国家医疗服务体系(NHS)和公共社会服务(PSS)的角度进行分析的。结果以质量调整生命年(QALY)进行量化。在急性症状性VTE(DVT或PE)患者中,当使用达比加群酯或华法林进行长达6个月的治疗时,估计的终身增量成本/QALY增益为1252英镑/QALY。在急性症状性PE和DVT的治疗中,各自的比率分别为1767英镑/QALY和1075英镑/QALY。在长达24个月的延长抗凝治疗中,与华法林相比,达比加群酯预计的成本/QALY为8242英镑/QALY。本文获得的结果在多项敏感性分析中都很稳健,表明在急性VTE(DVT和/或PE)后的6个月治疗和延长抗凝治疗中进行评估时,达比加群酯是当前护理标准具有成本效益的替代方案。

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