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利伐沙班单药治疗深静脉血栓和肺栓塞时的住院时间缩短。

Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism.

机构信息

Hospital Beneficência Portuguesa , São Paulo , Brazil.

出版信息

Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.

Abstract

OBJECTIVE

The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials.

METHODS

Analyses were carried out in the intention-to-treat population, using non-parametric and parametric statistical methods.

RESULTS

Overall, 52% (1781/3434) of EINSTEIN DVT patients and 90% (4328/4821) of EINSTEIN PE patients were admitted to hospital. The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54% compared with 31% for enoxaparin/vitamin K antagonist (VKA) in patients with DVT. For patients with PE, the corresponding values were 45% and 33%. Stays of 6-10 days were observed in 29% of rivaroxaban-treated patients compared with 45% of enoxaparin/VKA-treated patients for DVT. For patients with PE, these values were 39% and 46% in the rivaroxaban and enoxaparin/VKA groups, respectively. Overall, length of stay was significantly shorter in the rivaroxaban group, compared with the enoxaparin/VKA group across all analyses performed (p < 0.0001). Across regions, the observed admission rates and length of stay duration varied greatly: Asia had the longest overall hospitalization rates, whereas the lowest rates were reported in North America, Australia and New Zealand. Nevertheless, a consistent trend was observed: length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than, or at least similar to, patients receiving enoxaparin/VKA.

CONCLUSION

A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients, and provides effective and well tolerated treatment. The studies shared an open-label design that allowed comparison of initial hospitalization, but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management.

摘要

目的

III 期 EINSTEIN DVT 和 EINSTEIN PE 试验证明了口服利伐沙班治疗深静脉血栓形成(DVT)和肺栓塞(PE)的潜力。本研究使用这些试验的住院记录评估了出现有症状 DVT 或 PE 的患者的初始住院时间。

方法

使用意向治疗人群进行分析,采用非参数和参数统计方法。

结果

总体而言,EINSTEIN DVT 患者中有 52%(1781/3434)和 EINSTEIN PE 患者中有 90%(4328/4821)住院。接受利伐沙班治疗且住院时间为 5 天或更短的住院患者比例为 54%,而接受依诺肝素/维生素 K 拮抗剂(VKA)治疗的患者比例为 31%。对于 PE 患者,相应的值分别为 45%和 33%。接受利伐沙班治疗的患者中有 29%的住院时间为 6-10 天,而接受依诺肝素/VKA 治疗的患者中有 45%的住院时间为 6-10 天。对于 PE 患者,利伐沙班组和依诺肝素/VKA 组分别为 39%和 46%。总体而言,与依诺肝素/VKA 组相比,利伐沙班组的住院时间明显更短(所有分析 p<0.0001)。不同地区的住院率和住院时间差异很大:亚洲的总体住院率最高,而北美、澳大利亚和新西兰的住院率最低。然而,观察到了一致的趋势:接受利伐沙班或依诺肝素/VKA 治疗的 DVT 或 PE 患者的住院时间更短。

结论

利伐沙班单药治疗可能会减轻医疗系统和患者的负担,并提供有效且耐受良好的治疗。这些研究采用了开放性标签设计,允许比较初始住院情况,但存在局限性,包括在监测良好的临床试验环境下,入院和出院决策可能与实际管理不同。

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