评估体重不足的非瓣膜性心房颤动患者的阿哌沙班标准剂量:一项回顾性队列研究。

IF 2.6 4区 医学 Q2 HEMATOLOGY
Khalid Al Sulaiman, Ohoud Aljuhani, Hadeel Alkofide, Manal A Aljohani, Hisham A Badreldin, Mahasen Al Harbi, Ghalia Aquil, Raghad Alhajaji, Rahaf A Alqahtani, Alaa Babonji, Maha Altuwayr, Asma A Alshehri, Mashael Alfaifi, Abdullah F Alharthi, Mohammed Alzahrani, Tareq Al Sulaiman, Nasser Alqahtani, Walaa A Alshahrani, Abdulmalik Al Katheri, Abdulkareem M Albekairy
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引用次数: 0

摘要

背景:最新指南建议将直接口服抗凝剂(DOAC)作为非瓣膜性心房颤动(NVAF)患者的一线用药。目前正在对体重不足患者使用阿哌沙班的情况进行研究,一些研究结果表明,体重不足患者的药代动力学发生了改变,药物吸收减少,并可能出现用药过量。本研究考察了阿哌沙班标准剂量在体重低于50公斤的成年心房性NVAF患者中的有效性和安全性:这是一项在阿卜杜勒-阿齐兹国王医疗城(KAMC)进行的回顾性队列研究;根据患者开始服用阿哌沙班时的体重,将体重指数(BMI)低于 25 且接受标准剂量阿哌沙班(5 毫克,每天两次)治疗的成年患者分为两个子队列。体重不足指的是体重≤50 千克的患者,而对照组(正常体重)包括体重大于 50 千克的患者。在开始服用阿哌沙班后,我们对患者进行了至少一年的随访。研究的主要结果是中风事件的发生率,次要结果包括出血(大出血或小出血)、血栓形成和静脉血栓栓塞(VTE)。根据预先设定的标准,采用倾向评分(PS)以 1:1 的比例进行匹配,并酌情使用回归模型:共筛查了 1,433 名患者,其中 277 人符合资格标准。在粗略分析(0% vs. 9.1%)和回归分析(OR (95%CI):0.08 (0.001, 0.76),p 值 = 0.002)中,体重不足组的中风发生率低于体重正常组。)另一方面,两组患者发生大出血和小出血的几率无明显统计学差异(OR(95%CI):0.39(0.07,2.03),P值=0.26;OR(95%CI):1.27(0.56,2.84),P值=0.40):这项探索性研究显示,与体重正常的患者相比,体重过轻的 NVAF 患者接受标准剂量的阿哌沙班治疗后发生卒中的事件较少,但出血事件的差异无统计学意义。要证实这些发现,需要进一步开展样本量更大、观察时间更长的随机对照试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of Apixaban standard dosing in underweight patients with non-valvular atrial fibrillation: a retrospective cohort study.

Background: Recent guidelines recommend using direct oral anticoagulants (DOACs) as first-line agents in patients with non-valvular atrial fibrillation (NVAF). Research is currently investigating the use of Apixaban in underweight patients, with some results suggesting altered pharmacokinetics, decreased drug absorption, and potential overdosing in this population. This study examined the effectiveness and safety of standard Apixaban dosing in adult patients with atrial NVAF weighing less than 50 kg.

Methods: This is a retrospective cohort study conducted at King Abdulaziz Medical City (KAMC); adult patients with a body mass index (BMI) below 25 who received a standard dose of Apixaban (5 mg twice daily) were categorized into two sub-cohorts based on their weight at the time of Apixaban initiation. Underweight was defined as patients weighing ≤ 50 kg, while the control group (Normal weight) comprised patients weighing > 50 kg. We followed the patients for at least one year after Apixaban initiation. The study's primary outcome was the incidence of stroke events, while secondary outcomes included bleeding (major or minor), thrombosis, and venous thromboembolism (VTE). Propensity score (PS) matching with a 1:1 ratio was used based on predefined criteria and regression model was utilized as appropriate.

Results: A total of 1,433 patients were screened; of those, 277 were included according to the eligibility criteria. The incidence of stroke events was lower in the underweight than in the normal weight group at crude analysis (0% vs. 9.1%) p-value = 0.06), as well in regression analysis (OR (95%CI): 0.08 (0.001, 0.76), p-value = 0.002). On the other hand, there were no statistically significant differences between the two groups in the odds of major and minor bleeding (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40, respectively).

Conclusion: This exploratory study revealed that underweight patients with NVAF who received standard doses of Apixaban had fewer stroke events compared to normal-weight patients, without statistically significant differences in bleeding events. To confirm these findings, further randomized controlled trials with larger sample sizes and longer observation durations are required.

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来源期刊
Thrombosis Journal
Thrombosis Journal Medicine-Hematology
CiteScore
3.80
自引率
3.20%
发文量
69
审稿时长
16 weeks
期刊介绍: Thrombosis Journal is an open-access journal that publishes original articles on aspects of clinical and basic research, new methodology, case reports and reviews in the areas of thrombosis. Topics of particular interest include the diagnosis of arterial and venous thrombosis, new antithrombotic treatments, new developments in the understanding, diagnosis and treatments of atherosclerotic vessel disease, relations between haemostasis and vascular disease, hypertension, diabetes, immunology and obesity.
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