Rivaroxaban预防静脉血栓栓塞:一个技术评估。

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史蒂文森,一个范围,福尔摩斯M,里斯,Kaltenthaler E

Rivaroxaban预防静脉血栓栓塞:一个技术评估。

健康评估生物抛光工艺。2009年10月,13增刊3:43-8。doi: 10.3310 / hta13suppl3/07。

PubMed ID
19846028 (在PubMed
]
文摘

本文总结了证据的审查小组(ERG)调查报告的临床效果和成本效益rivaroxaban预防静脉血栓栓塞(VTE)择期髋关节或膝关节置换手术成年患者根据制造商的评论提交的国家健康和临床研究所(NICE)作为单一技术评估的一部分(STA)的过程。提交的证据来自四个随机对照试验(相关的)比较rivaroxaban伊诺肝素(记录(调节凝固在整形外科手术预防深静脉血栓形成和肺栓塞)1 - 4)和三个比较dabigatran和伊诺肝素(RE-NOVATE(全髋关节置换术后静脉血栓栓塞的预防试验),RE-MODEL(后静脉血栓栓塞的预防全膝关节置换试验)和RE-MOBILIZE(全膝关节置换术后静脉血栓栓塞的预防试验)]。四个记录试验的证据表明rivaroxaban卓越的功效了伊诺肝素后全髋关节置换(THR)和全膝关节置换(唯一)。复合主要结果的任何深静脉血栓形成(DVT),非致命性肺栓塞(PE)和因各种原因而死亡的相对危险度降低70 - 79%在唯一的刺,31 - 49%。Rivaroxaban也有卓越的功效在伊诺肝素的二次结果主要静脉血栓栓塞。Rivaroxaban并不次于伊诺肝素的安全性结果主要出血。发现一些错误修正后的ERG、制造商的经济模型代表一个合理的模型接受预防的患者用力推或唯一。的基本情况分析rivaroxaban伊诺肝素和dabigatran主导。增量成本节约和质量调整寿命(qaly)获得很小(人均分别低于200磅,0.005)。分析进行了相关的抽样分布的观察。 When all parameters were sampled rivaroxaban dominated enoxaparin in all scenarios except for two, in which enoxaparin produced more QALYs than rivaroxaban and had an incremental cost per QALY gained of 5000 pounds and 8000 pounds respectively. Rivaroxaban dominated dabigatran when RECORD 1 and RECORD 2, individually or pooled, were compared with RE-NOVATE and when all four rivaroxaban RCTs pooled were compared with all three dabigatran RCTs. Dabigatran dominated rivaroxaban comparing RECORD 4 with RE-MODEL and RE-MOBILIZE, and was more cost-effective than rivaroxaban comparing RECORD 3 (incremental cost per QALY gained of rivaroxaban compared with dabigatran of 123,000 pounds) or RECORD 3 and RECORD 4 pooled (incremental cost per QALY gained of dabigatran compared with rivaroxaban of 400 pounds) with RE-MODEL and RE-MOBILIZE. In conclusion, the evidence indicates that rivaroxaban is not inferior to enoxaparin in terms of the primary and secondary outcomes. The submission presents a reasonable estimation of the cost-effectiveness of rivaroxaban compared with enoxaparin and dabigatran, although the uncertainty in the decision has been underestimated. The results are particularly sensitive to any assumed difference in the number of fatal PEs, but the ERG does not believe there is sufficient evidence to support a difference between interventions. The NICE guidance issued as a result of the STA states that: riveroxaban, within its marketing authorisation, is recommended as an option for the prevention of venous thromboembolism in adults having elective THR or elective TKB.

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