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地高辛在老年房颤患者中的安全性:来自西班牙多中心注册研究的经验教训。

Safety of digoxin in nonagenarian patients with atrial fibrillation: lessons from the Spanish Multicenter Registry.

作者信息

Domínguez-Erquicia Pablo, Raposeiras-Roubín Sergio, Abu-Assi Emad, Cespón-Fernández María, Alonso-Rodríguez David, Camacho-Freire Santiago Jesús, Cubelos-Fernández Naiara, Ríos Álvaro López-Masjuán, Melendo-Viu María, Íñiguez-Romo Andrés

机构信息

Department of Cardiology, University Hospital Álvaro Cunqueiro, Vigo, Spain.

Health Research Institute Galicia Sur, Vigo, Spain.

出版信息

J Geriatr Cardiol. 2021 Oct 28;18(10):809-815. doi: 10.11909/j.issn.1671-5411.2021.10.007.

DOI:10.11909/j.issn.1671-5411.2021.10.007
PMID:34754292
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8558738/
Abstract

BACKGROUND

The association between digoxin and mortality is an unclear issue. In older patients with atrial fibrillation (AF), where use of digoxin is frequent, the evidence of its safety is scarce. Our aim is to assess the safety of digoxin in nonagenarian patients with AF.

METHODS

We evaluated data from 795 nonagenarian patients with non-valvular AF from the Spanish Multicenter Registry. We analyzed the relationship between digoxin and all-cause mortality with the Cox proportional-hazards model.

RESULTS

Follow-up was 27.7 ± 18.3 months. Mean age was 92.5 ± 3.8 years, and 71% of nonagenarian patients were female. Digoxin was not associated with increased risk of mortality [adjusted hazard ratio (aHR) = 1.16, 95% CI: 0.96-1.41, = 0.130]. However, we found a significant increase in mortality in the subgroup with estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m (aHR = 2.01, 95% CI: 1.13-3.57, = 0.018), but not in the other subgroups of eGFR (30-59 mL/min per 1.73 m and ≥ 60 mL/min per 1.73 m). When exploring the risk of mortality according to sex, male subgroup was associated with an increase in mortality (aHR = 1.48, 95% CI: 1.02-2.14, = 0.041). This was not observed in females subgroup (aHR = 1.03, 95% CI: 0.81-1.29, = 0.829). Based on the presence or absence of heart failure, we did not find significant differences (aHR = 1.20, 95% CI: 0.87-1.65, = 0.268 aHR = 1.15, 95% CI: 0.90-1.47, = 0.273, respectively).

CONCLUSIONS

In our large registry of nonagenarian patients with AF, we did not find an association between digoxin and mortality in the total sample. However, in the subgroup analyses, we found an increase in mortality with the use of digoxin in men and in patients with an eGFR < 30 mL/min per 1.73 m .

摘要

背景

地高辛与死亡率之间的关联尚不清楚。在老年房颤(AF)患者中,地高辛的使用较为频繁,但其安全性证据却很匮乏。我们的目的是评估地高辛在90岁以上房颤患者中的安全性。

方法

我们评估了来自西班牙多中心注册研究的795例90岁以上非瓣膜性房颤患者的数据。我们使用Cox比例风险模型分析了地高辛与全因死亡率之间的关系。

结果

随访时间为27.7±18.3个月。平均年龄为92.5±3.8岁,90岁以上患者中71%为女性。地高辛与死亡率增加无关[调整后风险比(aHR)=1.16,95%置信区间:0.96 - 1.41,P = 0.130]。然而,我们发现估计肾小球滤过率(eGFR)<30 mL/(min·1.73 m²)的亚组死亡率显著增加(aHR = 2.01,95%置信区间:1.13 - 3.57,P = 0.018),但在eGFR的其他亚组(30 - 59 mL/(min·1.73 m²)和≥60 mL/(min·1.73 m²))中未发现此情况。在按性别探索死亡率风险时,男性亚组死亡率增加(aHR = 1.48,95%置信区间:1.02 - 2.14,P = 0.041)。女性亚组未观察到这种情况(aHR = 1.03,95%置信区间:0.81 - 1.29,P = 0.829)。基于是否存在心力衰竭,我们未发现显著差异(分别为aHR = 1.20,95%置信区间:0.87 - 1.65,P = 0.268;aHR = 1.15,95%置信区间:0.90 - 1.47,P = 0.273)。

结论

在我们这个大型的90岁以上房颤患者注册研究中,我们在总样本中未发现地高辛与死亡率之间存在关联。然而,在亚组分析中,我们发现男性以及eGFR<30 mL/(min·1.73 m²)的患者使用地高辛会使死亡率增加。

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本文引用的文献

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Incidence, predictors of bleeding and prognosis of bleeding in anticoagulated nonagenarian patients with atrial fibrillation.90 岁以上合并房颤抗凝患者出血的发生率、出血预测因素及预后。
Int J Cardiol. 2021 Mar 15;327:217-222. doi: 10.1016/j.ijcard.2020.11.023. Epub 2020 Nov 18.
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Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.心房颤动患者的早期节律控制治疗。
N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
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2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC.
2020年欧洲心脏病学会(ESC)与欧洲心胸外科学会(EACTS)合作制定的心房颤动诊断和管理指南:欧洲心脏病学会(ESC)心房颤动诊断和管理特别工作组,由ESC欧洲心律协会(EHRA)特别贡献制定。
Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612.
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Vitamin K Antagonists and Direct Oral Anticoagulants in Nonagenarian Patients With Atrial Fibrillation.非老年患者维生素 K 拮抗剂和直接口服抗凝剂在心房颤动中的应用。
J Am Med Dir Assoc. 2020 Mar;21(3):367-373.e1. doi: 10.1016/j.jamda.2019.08.033. Epub 2019 Nov 19.
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Digoxin Use and Associated Adverse Events Among Older Adults.地高辛在老年患者中的应用及相关不良事件。
Am J Med. 2019 Oct;132(10):1191-1198. doi: 10.1016/j.amjmed.2019.04.022. Epub 2019 May 9.
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