西班牙利伐沙班治疗的非瓣膜性房颤患者概况:直接口服抗凝药物的不平等获得(HEROIC研究)

Juan Peris Vidal , María Ferreiro Argüelles , Rafael J. Hidalgo Urbano , Pascual Marco Vera , Antonio García Quintana , Joaquín Alonso Martín , José Antonio Vázquez de Prada Tiffe , José Mateo Arranz , Alejandro Isidoro Pérez Cabeza
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引用次数: 6

摘要

西班牙2013年治疗定位报告(TPR)对非瓣膜性房颤(NVAF)直接口服抗凝剂(DOACs)处方的限制可能会限制这种药物的使用。为了评估TPR的影响,我们分析了DOAC开利伐沙班的原因、接受治疗的非瓣膜性房颤患者的概况以及在属于国家卫生系统的医院接受治疗所需的时间,包括总体和自治区。方法对非瓣膜性房颤患者进行观察性、横断面、多中心研究,采用利伐沙班治疗。自治区根据最常见的处方实践进行分组:根据产品特征摘要(SmPC), TPR或更严格或修改的TPR (mTPR)。结果73名研究人员提供了1727名患者的数据。93.7%的患者存在高血栓栓塞风险(CHA2DS2-Vasc≥3),46.2%的患者存在出血高风险(ha - bled≥3)。自诊断为非瓣膜性房颤以来接受利伐沙班治疗的中位时间为21.1个月。57.0%的患者接受了维生素K拮抗剂(VKA)治疗。在以SmPC为处方指导的自治区,TPR/mTPR限制的患者有更高的血栓栓塞和出血风险,更频繁地接受VKA治疗,在接受利伐沙班治疗前等待的时间中位数要长20个月。结论西班牙接受利伐沙班治疗的患者血栓栓塞和出血风险较高。利伐沙班处方的中位治疗时间为21.1个月。对TPR的依附性差异造成了自治区之间的不平等。来自自治区的TPR/mTPR患者在20个月后接受利伐沙班治疗,显示出更高的血栓栓塞和出血风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perfil de pacientes con fibrilación auricular no valvular tratados con rivaroxaban en España: la desigualdad en el acceso a los anticoagulantes orales directos (estudio HEROIC)

Introduction and objectives

Restrictions on the prescription of direct oral anticoagulants (DOACs) for non-valvular atrial fibrillation (NVAF) treatment imposed in Spain by the 2013 Therapeutic Positioning Report (TPR) may limit access to this medication. With the aim of assessing the impact of the TPR, we analysed the reasons to prescribe the DOAC rivaroxaban, the profile of patients with NVAF treated and how long it takes accessing to the treatment in hospitals belonging to the National Health System, both overall and by autonomous regions.

Methods

An observational, cross-sectional, multicenter study of patients with NVAF treated with rivaroxaban in specialist practice. The autonomous regions were grouped according to the most common prescribing practices: per Summary of Product Characteristics (SmPC), TPR or a more restrictive or modified TPR (mTPR).

Results

73 researchers providing data on 1,727 patients participated. 93.7% of patients were at high thromboembolic risk (CHA2DS2-Vasc ≥ 3) and 46.2% were at high risk for bleeding (HAS-BLED ≥ 3). Median time since diagnosis of NVAF for receiving rivaroxaban was 21.1 months. 57.0% patients had received vitamin K antagonists (VKA). With respect to autonomous regions where prescribing practices are guided by SmPC, patients where TPR/mTPR restrictions were followed were at higher thromboembolic and bleeding risk, had received VKA more frequently and waited a median of ∼ 20 months longer before receiving rivaroxaban.

Conclusions

Patients treated with rivaroxaban in Spain show high thromboembolic and bleeding risks. Median time for rivaroxaban prescription is 21.1 months. The differences in the adhesion to the TPR create inequalities between autonomous regions. Patients from autonomous regions following the TPR/mTPR receive rivaroxaban up to 20 months later and show higher thromboembolic and bleeding risks.

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