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超重的非瓣膜性心房颤动患者达比加群酯与利伐沙班有效性和安全性的回顾性队列研究。

A retrospective cohort study of the effectiveness and safety of dabigatran versus rivaroxaban in overweight patients with nonvalvular atrial fibrillation.

机构信息

Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Int J Clin Pharm. 2022 Oct;44(5):1149-1157. doi: 10.1007/s11096-022-01443-2. Epub 2022 Jul 17.

DOI:10.1007/s11096-022-01443-2
PMID:35842869
Abstract

BACKGROUND

Guidance for dabigatran and rivaroxaban in overweight patients diagnosed with non-valvular atrial fibrillation (NVAF) is still lacking.

AIM

Compare the effectiveness and safety of dabigatran and rivaroxaban for the treatment of NVAF in the overweight population.

METHOD

A total of 396 out of 1029 overweight patients with NVAF at Zhongshan Hospital, Fudan University, from January 2017 and December 2018 were retrospectively enrolled using propensity score matching analysis. The clinical outcomes were analyzed by chi-square test and Kaplan-Meier analyses. The risk of bleeding and thrombosis was assessed using a Cox regression analysis and validated using a nomogram model.

RESULTS

In terms of effectiveness, the incidence of thrombosis events and the time to thrombosis were similar in the dabigatran and rivaroxaban groups (P > 0.05). Regarding safety, compared to dabigatran, the rivaroxaban group had a higher incidence of bleeding events (8.6% vs. 3.5%, χ = 4.435, P = 0.035), a shorter time to bleeding (11.3 ± 0.18 months vs. 11.6 ± 0.14 months, P = 0.038) and an increased risk of bleeding (hazard ratio HR = 2.452, 95% confidence interval CI 1.017-5.913, P = 0.046), especially in those patients with heart failure (HR = 3.207, 95% CI 1.183-8.694, P = 0.022).

CONCLUSION

Dabigatran therapy was shown to be equally effective. It may be superior in reducing bleeding risk in an overweight population with NVAF than rivaroxaban. Further prospective studies are encouraged for analysis.

摘要

背景

超重的非瓣膜性心房颤动(NVAF)患者应用达比加群和利伐沙班的指导意见仍缺乏。

目的

比较达比加群和利伐沙班治疗超重人群 NVAF 的有效性和安全性。

方法

采用倾向性评分匹配分析,回顾性纳入 2017 年 1 月至 2018 年 12 月复旦大学附属中山医院的 1029 例超重 NVAF 患者中的 396 例。采用卡方检验和 Kaplan-Meier 分析比较临床结局,采用 Cox 回归分析和列线图模型评估出血和血栓形成的风险。

结果

在有效性方面,达比加群组和利伐沙班组的血栓事件发生率和血栓形成时间相似(P>0.05)。安全性方面,与达比加群相比,利伐沙班组出血事件发生率更高(8.6% vs. 3.5%,χ²=4.435,P=0.035),出血时间更短(11.3±0.18 个月 vs. 11.6±0.14 个月,P=0.038),出血风险增加(风险比 HR=2.452,95%置信区间 CI 1.017-5.913,P=0.046),尤其是心力衰竭患者(HR=3.207,95%置信区间 CI 1.183-8.694,P=0.022)。

结论

达比加群治疗与利伐沙班同样有效,在超重 NVAF 人群中,达比加群可能降低出血风险。鼓励开展进一步的前瞻性研究进行分析。

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J Clin Med. 2021 Sep 16;10(18):4185. doi: 10.3390/jcm10184185.
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Use of direct oral anticoagulants in patients with obesity for treatment and prevention of venous thromboembolism: Updated communication from the ISTH SSC Subcommittee on Control of Anticoagulation.
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