Phenotypes of Patients with Direct Oral Anticoagulant (DOAC) Underdosing in Atrial Fibrillation: Results from the ARENA Registry.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2025-01-01 Epub Date: 2024-12-12 DOI:10.1007/s40261-024-01411-w

Christine Brockmüller, Andreas D Meid, Jochen Senges, Matthias Hochadel, Walter E Haefeli, Felicitas Stoll

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Abstract

Background and objectives: Oral anticoagulation in patients with atrial fibrillation is crucial to prevent thrombus formation in the heart, a major cause of ischemic stroke. The appropriate dose of direct oral anticoagulants (DOAC) - either standard or reduced dose - must be chosen individually in accordance with defined patient characteristics. However, a significant proportion of patients receive inappropriately low DOAC doses (underdosing). With a novel medication-based approach, this study aims to facilitate the identification of patients at risk of DOAC underdosing.

Methods: The prospective ARENA registry is a multi-centre study on patients with atrial fibrillation in Germany. Patients gave detailed information on medication, including over-the-counter preparations. Medication data were grouped according to the Anatomical Therapeutic Chemical (ATC) classification. In a bivariate analysis, the characteristics of patients on an appropriate versus inappropriate dose were compared (n = 866). To further evaluate variables for their association with underdosing, a model based on ATC third level medication data complemented with dose-adjustment criteria and validated clinical scores in all patients with complete information was built (n = 504).

Results: In 15% of patients, an inappropriately low dose was found. The number of DOAC drug interactions, concomitant antiplatelet therapy and the total drug count were the most important predictors of DOAC underdosing. Mineral supplements and better health-related quality of life (HrQoL) were predictive of correct DOAC dosing, among others.

Conclusions: Medication-related data showed to be predictive of DOAC underdosing. Clinicians should check for inappropriately reduced DOAC doses, especially in patients undergoing antiplatelet therapy, polypharmacy and reduced HrQoL.

Trial registration number: NCT02978248; date of registration: 30 November 2016.

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房颤患者直接口服抗凝剂（DOAC）剂量不足的表型：来自ARENA注册的结果

背景和目的：房颤患者口服抗凝对于预防心脏血栓形成至关重要，血栓形成是缺血性卒中的主要原因。直接口服抗凝剂（DOAC）的适当剂量——无论是标准剂量还是减少剂量——必须根据确定的患者特征单独选择。然而，相当比例的患者接受了不适当的低DOAC剂量（剂量不足）。通过一种新的基于药物的方法，本研究旨在促进DOAC剂量不足风险患者的识别。方法：前瞻性ARENA注册是一项针对德国房颤患者的多中心研究。患者提供了药物的详细信息，包括非处方制剂。用药资料按解剖治疗化学（ATC）分类进行分组。在双变量分析中，比较了适当剂量和不适当剂量患者的特征（n = 866）。为了进一步评估与剂量不足相关的变量，在所有信息完整的患者中建立了一个基于ATC三级用药数据、剂量调整标准和经过验证的临床评分的模型（n = 504）。结果：15%的患者用药剂量过低。DOAC药物相互作用次数、同时抗血小板治疗和总药物计数是DOAC用药不足的最重要预测因子。矿物质补充剂和更好的健康相关生活质量（HrQoL）可预测正确的DOAC剂量等。结论：药物相关数据显示可预测DOAC剂量不足。临床医生应检查DOAC剂量的不适当减少，特别是在接受抗血小板治疗、多种药物治疗和HrQoL降低的患者中。试验注册号：NCT02978248；注册日期：2016年11月30日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.