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心房颤动患者每日一次和每日两次直接口服抗凝剂依从性的电子监测:SMAAP-AF试验的基线数据。

Electronic monitoring of adherence to once-daily and twice-daily direct oral anticoagulants in patients with atrial fibrillation: Baseline data from the SMAAP-AF trial.

作者信息

Shiga Tsuyoshi, Kimura Toshimi, Fukushima Noritoshi, Yoshiyama Yuji, Iwade Kazunori, Mori Fumiaki, Ajiro Yoichi, Haruta Shoji, Yamada Yuichiro, Sawada Emi, Hagiwara Nobuhisa

机构信息

Department of Cardiology Tokyo Women's Medical University Tokyo Japan.

Department of Clinical Pharmacology and Therapeutics The Jikei University School of Medicine Tokyo Japan.

出版信息

J Arrhythm. 2021 Mar 30;37(3):616-625. doi: 10.1002/joa3.12532. eCollection 2021 Jun.

Abstract

BACKGROUND

Nonadherence diminishes the efficacy of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (NVAF). This report presents the baseline survey results regarding medication adherence among NVAF patients who were treated with once-daily edoxaban or twice-daily apixaban from a randomized control trial of the effect of an educational intervention on DOAC adherence.

METHODS

We prospectively studied 301 NVAF patients who were treated with edoxaban (n = 175) or apixaban (n = 126) during the 12-week observation period. Adherence was measured with an electronic monitoring system and is expressed as the percentage of days with the correct doses in the measurement period (days). Adherence to DOAC therapy was defined based on the standard threshold (≥80%) or a strict threshold (≥90%).

RESULTS

Of the 301 patients, 33 had incomplete data or protocol deviations, leaving 268 patients (edoxaban 158 and apixaban 110) for the per-protocol baseline analysis. There was no difference in adherence (threshold ≥80%) between the groups (edoxaban 95% vs apixaban 91%,  = .2), but there was a lower proportion of patients with strict adherence (threshold ≥90%) among apixaban users than among edoxaban users (edoxaban 87% vs apixaban 76%,  = .02). Multivariate analysis showed a negative relationship between apixaban use and an adherence rate ≥90% (odds ratio 0.49, 95% confidence interval [CI]: 0.25-0.94).

CONCLUSIONS

Our study showed that the proportion of DOAC users with adherence (≥80%) did not differ between the groups, but the proportion of patients with strict adherence (≥90%) was lower among those using apixaban than among those using edoxaban.

摘要

背景

在非瓣膜性心房颤动(NVAF)患者中,不依从性会降低直接口服抗凝剂(DOACs)的疗效。本报告展示了一项关于教育干预对DOAC依从性影响的随机对照试验中,接受每日一次依度沙班或每日两次阿哌沙班治疗的NVAF患者用药依从性的基线调查结果。

方法

我们前瞻性地研究了301例NVAF患者,这些患者在12周观察期内接受依度沙班(n = 175)或阿哌沙班(n = 126)治疗。使用电子监测系统测量依从性,并表示为测量期(天数)内正确剂量的天数百分比。根据标准阈值(≥80%)或严格阈值(≥90%)定义对DOAC治疗的依从性。

结果

301例患者中,33例数据不完整或存在方案偏差,剩余268例患者(依度沙班158例和阿哌沙班110例)进行符合方案的基线分析。两组间依从性(阈值≥80%)无差异(依度沙班95% vs阿哌沙班91%,P = 0.2),但阿哌沙班使用者中严格依从(阈值≥90%)的患者比例低于依度沙班使用者(依度沙班87% vs阿哌沙班76%,P = 0.02)。多因素分析显示,使用阿哌沙班与依从率≥90%之间存在负相关(比值比0.49,95%置信区间[CI]:0.25 - 0.94)。

结论

我们的研究表明,两组间DOAC使用者依从性(≥80%)的比例无差异,但使用阿哌沙班的患者中严格依从(≥90%)的比例低于使用依度沙班的患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4bb/8207342/7587540937cb/JOA3-37-616-g001.jpg

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