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在美国老年医疗保险受益人群中,使用真实世界证据对比达比加群与利伐沙班预防非瓣膜性心房颤动患者中风的成本效益分析。

Cost-effectiveness analysis of dabigatran versus rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation using real-world evidence in elderly US Medicare beneficiaries.

作者信息

Peng Siyang, Deger Kristen A, Ustyugova Anastasia, Gandhi Pranav, Qiao Nan, Wang Cheng, Kansal Anuraag R

机构信息

a Evidera , Bethesda , MD , USA.

b Boehringer Ingelheim GmbH, Ingelheim am Rhein , Germany.

出版信息

Curr Med Res Opin. 2018 Jan;34(1):55-63. doi: 10.1080/03007995.2017.1375470. Epub 2017 Sep 26.

Abstract

OBJECTIVE

Dabigatran and rivaroxaban have been approved by the US FDA to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients. Newly published real-world evidence based on the US population found that elderly Medicare patients with NVAF treated with rivaroxaban experienced statistically significant increases in intracranial hemorrhage (ICH) and major extracranial bleeding, and statistically nonsignificant decreases in thromboembolic stroke and acute myocardial infarction (AMI) compared with dabigatran. This study assessed the cost-effectiveness of dabigatran vs. rivaroxaban for the treatment of US Medicare NVAF patients.

METHODS

A previously published Markov model was adapted to compare dabigatran and rivaroxaban. The model considered thromboembolic stroke, bleeding events, and AMI based on the published real-world event risks. Model outputs included clinical event rates, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

RESULTS

Dabigatran patients experienced fewer ICH and major extracranial bleeding events than rivaroxaban patients, but more stroke and AMI events. Dabigatran was found to yield lower costs and higher QALYs than rivaroxaban, with incremental costs of -$3534 and incremental QALYs of 0.004. Results remained consistent in sensitivity analyses, with a positive net monetary benefit (willingness-to-pay thresholds of $50,000 and $100,000 per QALY) for dabigatran over rivaroxaban for all model inputs tested.

CONCLUSIONS

In this study using US Medicare real-world data, dabigatran was found to dominate rivaroxaban. The analyses were limited by the short follow-up period of the real-world data and results may not be generalizable to other patient populations.

摘要

目的

达比加群和利伐沙班已获美国食品药品监督管理局(FDA)批准,用于降低非瓣膜性心房颤动(NVAF)患者的中风和全身性栓塞风险。基于美国人群的最新真实世界证据发现,与达比加群相比,接受利伐沙班治疗的老年医疗保险NVAF患者颅内出血(ICH)和主要颅外出血在统计学上显著增加,而血栓栓塞性中风和急性心肌梗死(AMI)在统计学上无显著降低。本研究评估了达比加群与利伐沙班治疗美国医疗保险NVAF患者的成本效益。

方法

采用先前发表的马尔可夫模型比较达比加群和利伐沙班。该模型根据已发表的真实世界事件风险考虑血栓栓塞性中风、出血事件和AMI。模型输出包括临床事件发生率、成本、质量调整生命年(QALY)和增量成本效益比(ICER)。

结果

达比加群患者的ICH和主要颅外出血事件比利伐沙班患者少,但中风和AMI事件更多。发现达比加群比利伐沙班成本更低、QALY更高,增量成本为-3534美元,增量QALY为0.004。敏感性分析结果保持一致,对于所有测试的模型输入,达比加群相对于利伐沙班具有正的净货币效益(每QALY支付意愿阈值为50,000美元和100,000美元)。

结论

在这项使用美国医疗保险真实世界数据的研究中,发现达比加群优于利伐沙班。分析受到真实世界数据随访期短的限制,结果可能不适用于其他患者群体。

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