Department of Pharmaceutical Biomedicine, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Data Science Division, Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
Fam Pract. 2019 Nov 18;36(6):685-692. doi: 10.1093/fampra/cmz016.
Oral anticoagulants use has increased rapidly, internationally. Here we look at risks and benefits, based on Japanese data, of therapy with low risk non-valvular atrial fibrillation patients.
Using a health insurance claims data set we assessed: (i) oral anticoagulants usage in Japan, and (ii) efficacy and safety of dabigatran compared with warfarin, in Japanese patients with non-valvular atrial fibrillation, aged 18-74 years.
We identified 4380 non-valvular atrial fibrillation patients treated with anticoagulants between 1 January 2005, and 28 February 2014, and estimated the adjusted hazard ratio for stroke or systemic embolism, and any hemorrhagic event (Cox proportional hazards regression model with stabilized inverse probability treatment weighting).
The data included 101 989 anticoagulant prescriptions for 4380 patients, of which direct oral anticoagulants increased to 40.0% of the total by the end of the study. After applying exclusion criteria, 1536 new non-valvular atrial fibrillation patients were identified, including 1071 treated with warfarin and 465 with dabigatran. Mean ages were 56.11 ± 9.70 years for warfarin, and 55.80 ± 9.65 years for dabigatran. The adjusted hazard ratio (95% confidence interval), comparing dabigatran with warfarin, was 0.48 (0.25-0.91) for stroke or systemic embolism, and 0.91 (0.60-1.39) for any hemorrhage including intracranial and gastrointestinal.
Number of patients prescribed direct oral anticoagulants steadily increased, and incidence of all-cause bleeding related to dabigatran was similar to warfarin, in our study population of younger non-valvular atrial fibrillation patients. Dabigatran, compared with warfarin, generally reduced risk of all-cause stroke and systemic embolism.
在国际范围内,口服抗凝剂的使用迅速增加。在这里,我们根据日本的数据研究了低风险非瓣膜性房颤患者的治疗风险和益处。
使用健康保险索赔数据集,我们评估了:(i)日本的口服抗凝剂使用情况;(ii)与华法林相比,达比加群在 18-74 岁日本非瓣膜性房颤患者中的疗效和安全性。
我们确定了 4380 名在 2005 年 1 月 1 日至 2014 年 2 月 28 日期间接受抗凝治疗的非瓣膜性房颤患者,并使用 Cox 比例风险回归模型(具有稳定逆概率治疗加权的协变量)估计了卒中或全身性栓塞以及任何出血事件的调整后的风险比。
数据包括 4380 名患者的 101989 份抗凝剂处方,其中直接口服抗凝剂在研究结束时增加到总处方的 40.0%。应用排除标准后,确定了 1536 名新的非瓣膜性房颤患者,其中 1071 名接受华法林治疗,465 名接受达比加群治疗。华法林组的平均年龄为 56.11 ± 9.70 岁,达比加群组为 55.80 ± 9.65 岁。与华法林相比,达比加群用于卒中或全身性栓塞的调整后的风险比(95%置信区间)为 0.48(0.25-0.91),用于任何出血事件(包括颅内和胃肠道出血)的风险比为 0.91(0.60-1.39)。
在我们的年轻非瓣膜性房颤患者研究人群中,接受直接口服抗凝剂治疗的患者数量稳步增加,且达比加群相关的全因出血发生率与华法林相似。与华法林相比,达比加群通常降低了全因卒中及全身性栓塞的风险。