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老年非瓣膜性心房颤动患者直接口服抗凝剂换药及剂量变化的发生率和预测因素:一项对大型管理数据库的5年分析

Incidence and Predictors of Switching and Dose Change of Direct Oral Anticoagulants among Elderly Patients with Nonvalvular Atrial Fibrillation: A 5-Year Analysis of a Large Administrative Database.

作者信息

De Luca Leonardo, Dovizio Melania, Sangiorgi Diego, Perrone Valentina, Degli Esposti Luca

机构信息

Department of Cardio-Thoracic-Vascular Sciences, A.O. San Camillo-Forlanini, 00151 Rome, Italy.

Department of Cardio-Thoracic and Vascular Medicine and Surgery, U.O.C. Cardiologia, Azienda Ospedaliera San Camillo-Forlanini Circonvallazione Gianicolense, 87, 00152 Roma, Italy.

出版信息

J Clin Med. 2023 Mar 19;12(6):2379. doi: 10.3390/jcm12062379.

Abstract

In the last decade, novel oral anticoagulants (NOACs) have emerged as prominent therapeutic options in non-valvular atrial fibrillation (NVAF). We analysed the clinical burden and the switching rate between all available NOACs, and their dosage change over a period of 5 years in a representative population of patients with NVAF aged between 70 and 75 years. Methods and Results: This is a retrospective observational study on administrative databases, covering approximately 6.2 million health-assisted individuals by the Italian National Health System (around 11% of the entire Italian residents). Out of 4640 NVAF patients treated with NOACs and aged 70-75 years in 2017, 3772 (81.3%) patients were still in treatment with NOAC up to 2021 and among them, 3389 (73.0%) patients remained in treatment with the same NOAC during 2017-2021. In fact, 10.2% of patients switched NOAC type and 10.3% changed the dose of the same NOAC. Overall, after switching, the dabigatran and rivaroxaban groups lost, respectively, 13.5% and 2.8% of patients, while apixaban and edoxaban resulted in a relative percentage increase of 6.8% and 44.6% of patients, respectively. By a logistic regression analysis, the treatment with rivaroxaban, apixaban, and edoxaban (respect to dabigatran) was associated with a significant risk reduction of switch of 57%, 68%, and 44%, respectively. On the other hand, several features of high risk were associated with dose reduction. Conclusions. In our 5-year analysis of a large administrative database, a switching among NOACs or a change in NOAC dosages occurred in around 20% of elderly patients with NVAF. The type of NOAC was associated with a high switching rate, while several characteristics of high risk resulted as predictors of dose reduction of NOACs. Moreover, a worsening trend of clinical conditions occurred in patients maintaining the same NOAC treatment across 2017-2021.

摘要

在过去十年中,新型口服抗凝药(NOACs)已成为非瓣膜性心房颤动(NVAF)的重要治疗选择。我们分析了所有可用NOACs之间的临床负担和转换率,以及在年龄在70至75岁的代表性NVAF患者群体中,其在5年期间的剂量变化。方法与结果:这是一项基于行政数据库的回顾性观察研究,涵盖了意大利国家卫生系统约620万接受医疗救助的个体(约占意大利全部居民的11%)。在2017年接受NOACs治疗且年龄在70 - 75岁的4640例NVAF患者中,到2021年仍有3772例(81.3%)患者继续接受NOACs治疗,其中3389例(73.0%)患者在2017 - 2021年期间继续使用同一种NOACs治疗。实际上,10.2%的患者更换了NOACs类型,10.3%的患者改变了同一种NOACs的剂量。总体而言,更换后,达比加群和利伐沙班组分别有13.5%和2.8%的患者流失,而阿哌沙班和依度沙班组患者相对百分比分别增加了6.8%和44.6%。通过逻辑回归分析,与达比加群相比,使用利伐沙班、阿哌沙班和依度沙班治疗分别使换药风险显著降低57%、68%和44%。另一方面,一些高风险特征与剂量减少相关。结论。在我们对一个大型行政数据库的5年分析中,约20%的老年NVAF患者发生了NOACs之间的换药或NOACs剂量的改变。NOACs的类型与高换药率相关,而一些高风险特征是NOACs剂量减少的预测因素。此外,在2017 - 2021年期间维持相同NOACs治疗的患者临床状况有恶化趋势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d6a/10056372/26349141343d/jcm-12-02379-g001.jpg

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