Analysis on risk of atrial fibrillation due to ivabradine based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20200706-00742
- VernacularTitle:基于美国FDA不良事件报告系统数据库的伊伐布雷定致心房颤动风险分析
- Author:
Zhenguo XIE
1
;
Lin CHEN
;
Kun YU
;
Zhe PENG
;
Hongmei GONG
;
Yunpeng LIAO
;
Min LIN
Author Information
1. 重庆大学附属三峡医院药学部，重庆 404000
- Publication Type:Journal Article
- Keywords:
Ivabradine;
Atrial fibrillation;
Adverse drug reaction reporting systems
- From:
Adverse Drug Reactions Journal
2021;23(2):69-75
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the risk and influencing factors of atrial fibrillation (AF) due to ivabradine.Methods:The database of US FDA Adverse Event Reporting System (FAERS) was searched and the drug-related adverse event (AE) reports from the 2nd quarter of 2015 to the 4th quarter of 2019 were extracted. According to the first suspicious drug, the reports were divided into ivabradine group and other drugs group, which were further divided into AF event group and non AF event group, respectively. The signal intensity of AF events related to ivabradine was screened and statistically analyzed by reporting odds ratio ( ROR). If the number of AF events was more than 3 and the lower limit of 95% confidence interval ( CI) of ROR was more than 1, the AF signal was positive. The stability of the results was evaluated by subgroup analysis and sensitivity analysis and the adjusted ROR value was calculated using logistic regression model in order to reduce the influence of confounding factors. The differences of clinical characteristics such as age, gender, dose, and indications between patients in the AF event group and non AF event group were compared. The clinical characteristics with significant difference ( P<0.05) were enrolled in the multivariate logistic regression model to analyze the influencing factors of AF induced by ivabradine. Results:A total of 6 019 954 reports were entered in the analysis, including 1 799 cases (0.03%) in the ivabradine group and 6 018 155 cases (99.97%) in the other drugs group. There were 51 cases (2.83%) of AF events in the ivabradine group and 24 266 cases (0.40%) of AF events in the other drugs group. The overall ROR of AF events induced by ivabradine was 7.21 (95 %CI: 5.45-9.52) and the overall adjusted ROR was 6.81 (95 %CI: 5.13-9.02). The results of subgroup analysis and sensitivity analysis were consistent with the results of overall analysis basically. Multivariate logistic regression analysis showed that the risks of AF after ivabradine administration in the 70-79 years old and ≥80 years old patients were higher than that in the <60 years old patients [odds ratio ( OR)=6.525, 95 %CI: 1.896-22.456, P=0.003; OR=4.948, 95 %CI: 1.050- 23.315, P=0.043]. Conclusions:Ivabradine has a risk of AF. Advanced age may be associated with increased risk of ivabradine related AF.
