非维生素 K 拮抗剂口服抗凝剂与血管性水肿：一项队列研究和病例交叉研究。
Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study.
机构信息
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA.
出版信息
Drug Saf. 2019 Nov;42(11):1355-1363. doi: 10.1007/s40264-019-00852-z.
INTRODUCTION
Patients taking non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban have reported experiencing angioedema in randomized trials and routine care.
OBJECTIVE
The aim of this study was to quantify the association between NOACs and angioedema relative to warfarin among routinely treated patients with atrial fibrillation in a cohort study. We also compared warfarin users with non-users in a case-crossover study.
METHODS
We utilized a cohort design that drew eligible patients from the Truven Health MarketScan Commercial database, the Optum Clinformatics Data Mart, and Medicare. Within each database, we compared the 6-month relative rate of angioedema among new users of NOACs (dabigatran, rivaroxaban, apixaban) and new users of warfarin. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) after adjusting for confounders using propensity score stratification, and meta-analyzed the database-specific HRs using a random-effects model. We also estimated an odds ratio (OR) for the association between warfarin and angioedema using a case-crossover design, a self-controlled design that controls for time-invariant confounders.
RESULTS
In the cohort study, we observed 249 incident angioedema events among 267,681 NOAC initiators and 281,143 warfarin initiators across all databases. The meta-analyzed HR for angioedema comparing any NOAC versus warfarin was 0.98 (95% CI 0.76-1.27). In the case-crossover design, the OR for the association between warfarin and angioedema was 0.91 (95% CI 0.68-1.21) based on 431 cases.
CONCLUSIONS
Our estimates were inconsistent with substantial short-term relative increases in the rate of angioedema associated with oral anticoagulant therapy.
简介
在随机试验和常规治疗中，服用达比加群、利伐沙班和阿哌沙班等非维生素 K 拮抗剂口服抗凝剂（NOAC）的患者报告出现血管性水肿。
目的
本研究旨在通过队列研究，在常规治疗的房颤患者中，定量评估与华法林相比，NOAC 与血管性水肿的相关性。我们还在病例交叉研究中比较了华法林使用者和非使用者。
方法
我们使用了队列设计，从 Truven Health MarketScan 商业数据库、Optum Clinformatics Data Mart 和 Medicare 中抽取符合条件的患者。在每个数据库中，我们比较了新使用达比加群（dabigatran）、利伐沙班（rivaroxaban）和阿哌沙班（apixaban）的 NOAC 新使用者和新使用华法林的患者在 6 个月内血管性水肿的相对发生率。我们使用倾向评分分层调整混杂因素后，估计了危险比（HRs）和 95%置信区间（CIs），并使用随机效应模型对数据库特异性 HR 进行了荟萃分析。我们还使用病例交叉设计，一种控制时间不变混杂因素的自身对照设计，估计了华法林与血管性水肿之间关联的比值比（OR）。
结果
在队列研究中，我们观察到在所有数据库中，267681 名 NOAC 使用者和 281143 名华法林使用者中，有 249 例新发血管性水肿事件。比较任何 NOAC 与华法林的血管性水肿的荟萃分析 HR 为 0.98（95%CI 0.76-1.27）。在病例交叉设计中，基于 431 例病例，华法林与血管性水肿之间关联的 OR 为 0.91（95%CI 0.68-1.21）。
结论
我们的估计与抗凝治疗相关的血管性水肿发生率短期相对增加不一致。
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