A retrospective cohort study on the effect of concomitant amiodarone on bleeding risk in atrial fibrillation patients with dabigatran etexilate treatment
10.3760/cma.j.cn114015-20240603-00409
- VernacularTitle:并用胺碘酮对达比加群酯治疗心房颤动患者出血风险影响的回顾性队列研究
- Author:
Anhua WEI
1
;
Lu WANG
1
;
Lu ZENG
1
;
Wei LI
1
;
Xuepeng GONG
1
;
Dong LIU
1
Author Information
1. 华中科技大学同济医学院附属同济医院药学部，武汉 430033
- Publication Type:Journal Article
- Keywords:
Dabigatran;
Amiodarone;
Drug interaction;
Atrial fibrillation;
Bleeding
- From:
Adverse Drug Reactions Journal
2025;27(1):6-10
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the effect of concomitant amiodarone on the bleeding risk in atrial fibrillation patients treated with dabigatran etexilate.Methods:This study was a retrospective cohort study. The clinical data of hospitalized patients with atrial fibrillation who took dabigatran etexilate in Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology from July 1, 2022 to June 30, 2023 were collected. Patients were divided into concomitant amiodarone group and non concomitant amiodarone group according to whether they were treated with oral amiodarone. Propensity score matching (PSM) was performed at a 1∶1 ratio in patients between the 2 groups according to patient's gender, age, main basic diseases and the number of basic diseases, baseline liver and kidney function, dosage of dabigatran etexilate, etc. The incidence of bleeding events was compared between the 2 groups.Results:A total of 878 patients were included in the study, including 568 males (64.7%) and 310 females (35.3%), with a age of 67 (59, 74) years. There were 252 patients (28.7%) in the concomitant amiodarone group and 626 patients (71.3%) in the non concomitant amiodarone group. Within 3 months of follow-up, the incidence of bleeding events in patients of concomitant and non concomitant amiodarone groups were 19.0% (48/252) and 21.2% (133/626), respectively, which were 19.0% (48/252) and 16.7% (40/239) after PSM, respectively, with no significant difference (all P>0.05). The main type of bleeding in patients of both groups was mild bleeding events [62.5% (30/48) vs. 67.5% (27/40)], and bleeding was more common in the gums, skin, and nose. There was no statistically significant difference in incidence of the bleeding types and bleeding sites of patients between the 2 groups (all P>0.05). Conclusions:Compared with patients with atrial fibrillation when treated with dabigatran etexilate and without concomitant amiodarone, the bleeding risk of patients with amiodarone did not significantly increased in the short term. The bleeding events during treatment of dabigatran etexilate were mainly mild bleeding, but clinical vigilance was still necessary.
