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阿哌沙班、达比加群和利伐沙班与华法林预防非瓣膜性心房颤动卒中共效性分析:成本效益研究。

Apixaban, dabigatran, and rivaroxaban versus warfarin for stroke prevention in non-valvular atrial fibrillation: a cost-effectiveness analysis.

机构信息

Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.

出版信息

Clin Drug Investig. 2014 Jan;34(1):9-17. doi: 10.1007/s40261-013-0144-3.

Abstract

BACKGROUND AND OBJECTIVE

Non-valvular atrial fibrillation (NVAF) increases the risk of systemic thromboembolic events; therefore, anticoagulant treatment with vitamin K antagonists is widely prescribed. Recently, new oral anticoagulants (NOAs) directly inhibiting thrombin (dabigatran) or factor Xa (rivaroxaban and apixaban) demonstrated their non-inferiority with respect to warfarin in reducing the thromboembolic risk. The aim of this study was to estimate the cost effectiveness of NOAs in an Italian setting.

METHODS

A Markov decision model including ten health states and death was developed, and a 3-month Markov cycle and lifetime horizon were adopted. Transition probabilities and quality of life were estimated from three randomized trials and from additional reports in the literature. Analysis was performed in the context of the Italian National Health System. First- and second-order sensitivity analyses were made to test the robustness of the results. The mean European cost of dabigatran (2.58/day) was assigned to each NOA.

RESULTS

The incremental cost-utility ratio was below 25,000/quality-adjusted life-year (QALY) gained for each NOA and each CHADS2 level, but differences among drugs were found. This result was sensitive to the time in (warfarin) therapeutic range and time horizon.

CONCLUSIONS

Our analysis suggests that NOAs are a cost-effective treatment for the prevention of stroke in patients with NVAF in the Italian healthcare setting.

摘要

背景与目的

非瓣膜性心房颤动(NVAF)会增加全身性血栓栓塞事件的风险;因此,广泛应用维生素 K 拮抗剂进行抗凝治疗。最近,直接抑制凝血酶(达比加群)或因子 Xa(利伐沙班和阿哌沙班)的新型口服抗凝剂(NOAs)在降低血栓栓塞风险方面已被证实不劣于华法林。本研究旨在评估意大利环境下使用 NOAs 的成本效益。

方法

开发了一个包含十个健康状态和死亡的 Markov 决策模型,并采用了 3 个月的 Markov 周期和终生时间范围。转移概率和生活质量从三项随机试验和文献中的其他报告中进行了估算。分析是在意大利国家卫生系统的背景下进行的。进行了第一和第二阶敏感性分析,以测试结果的稳健性。将达比加群的平均欧洲成本(2.58/天)分配给每种 NOA。

结果

对于每种 NOA 和每个 CHADS2 水平,增量成本效益比均低于25,000/获得的质量调整生命年(QALY),但药物之间存在差异。这一结果对(华法林)治疗范围内的时间和时间范围敏感。

结论

我们的分析表明,NOAs 是意大利医疗保健环境中预防 NVAF 患者中风的一种具有成本效益的治疗方法。

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