一项队列研究评估不同口服抗凝药物使用者发生皮肤小血管血管炎的风险。
A cohort study to assess risk of cutaneous small vessel vasculitis among users of different oral anticoagulants.
机构信息
Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Harvard Medical School Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA.
出版信息
Pharmacoepidemiol Drug Saf. 2022 Nov;31(11):1164-1173. doi: 10.1002/pds.5514. Epub 2022 Aug 15.
PURPOSE
Cutaneous small vessel vasculitis (CSVV) was identified as a safety signal among patients treated with direct oral anticoagulants (DOAC). This study aimed to determine if CSVV risk differed among patients with atrial fibrillation (Afib) who newly initiated warfarin or a DOAC.
METHODS
We identified enrollees aged ≥21 years diagnosed with Afib who newly initiated rivaroxaban, dabigatran, apixaban, and warfarin in the Sentinel Distributed Database from October 19, 2010 to February 29, 2020. We selected and followed patients who did not have evidence of the following in the 183 days prior to initiating treatment: CSVV diagnosis, dispensing of other study drugs, select autoimmune diseases or autoimmune medications, cancer diagnoses or chemotherapeutic treatment, kidney dialysis or transplant, alternative anticoagulation indications, or an institutional (nursing home, hospice, hospital) stay on the treatment initiation date (index date) until CSVV outcome or pre-specified censoring. We conducted 1:1 propensity score matching in six comparisons.
RESULTS
CSVV incidence rates for DOACs and warfarin ranged from 3.3 to 5.6 per 10 000-person years in our matched Afib population. The adjusted CSVV hazard ratio (HR) and 95% confidence interval (CI) was 0.94 (0.64, 1.39) for rivaroxaban versus warfarin; 1.17 (0.67, 2.06) for dabigatran vs. warfarin; 0.85 (0.62, 1.16) for apixaban vs. warfarin; 0.86 (0.49, 1.50) for rivaroxaban vs. dabigatran; 0.99 (0.68, 1.45) for rivaroxaban versus apixaban; and 1.70 (0.90, 3.21) for dabigatran versus apixaban.
CONCLUSION
We did not find significant evidence of differential CSVV risk in pair-wise comparisons of DOACs and warfarin.
目的
皮肤小血管血管炎（CSVV）在接受直接口服抗凝剂（DOAC）治疗的患者中被确定为一种安全信号。本研究旨在确定新开始使用华法林或 DOAC 的房颤（Afib）患者中 CSVV 风险是否不同。
方法
我们从 2010 年 10 月 19 日至 2020 年 2 月 29 日在 Sentinel 分布式数据库中确定了年龄≥21 岁的新开始使用利伐沙班、达比加群、阿哌沙班和华法林治疗的 Afib 患者。我们选择并随访了在开始治疗前 183 天内没有以下证据的患者：CSVV 诊断、其他研究药物的配药、选择自身免疫性疾病或自身免疫性药物、癌症诊断或化学治疗、肾脏透析或移植、替代抗凝指征或治疗开始日期（索引日期）当天的机构（疗养院、临终关怀、医院）住院，直到 CSVV 结果或预先指定的截止日期。我们在六组比较中进行了 1:1 的倾向评分匹配。
结果
在我们匹配的 Afib 人群中，DOAC 和华法林的 CSVV 发生率范围为每 10000 人年 3.3 至 5.6 例。调整后的 CSVV 风险比（HR）和 95%置信区间（CI）为利伐沙班与华法林相比为 0.94（0.64，1.39）；达比加群与华法林相比为 1.17（0.67，2.06）；阿哌沙班与华法林相比为 0.85（0.62，1.16）；利伐沙班与达比加群相比为 0.86（0.49，1.50）；利伐沙班与阿哌沙班相比为 0.99（0.68，1.45）；达比加群与阿哌沙班相比为 1.70（0.90，3.21）。
结论
我们没有发现 DOAC 和华法林之间在 CSVV 风险方面存在显著差异的证据。
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