单位:[1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China药学部华中科技大学同济医学院附属同济医院[2]Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan[3]School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China[4]Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院
ObjectiveQuetiapine, an atypical second-generation antipsychotic drug, is approved for treatment of schizophrenia, bipolar disorder, and depression. Due to the limitations of clinical trials, the association between quetiapine and rare cardiac adverse events (AEs) is still unclear. This study is to evaluate quetiapine-associated cardiac AEs through data mining of FDA Adverse Event Reporting System (FAERS). MethodsReporting odds ratio (ROR) was used to quantify the signals of quetiapine-related cardiac AEs from the first quarter (Q1) of 2018-2022 Q1. Serious and nonserious cases were compared, and signals were prioritized using a rating scale. ResultsA total of 1004 cases of quetiapine-associated cardiac AEs were identified, with 31 signals being detected, among which 13 AEs were identified as new and unexpected signals. Besides, nine and 22 cardiac AEs were identified as moderate and weak clinical priority. The median TTO for moderate and weak clinical priority signals were 0 and 4 days, respectively. All of the cardiac AEs had early failure type characteristics, suggesting that most of the patients developed cardiac AEs in a few days after quetiapine treatment, and that the risk of cardiac AEs occurrence would be gradually decreased over time. ConclusionOur study provided valuable evidence for health-care professionals to mitigate the risk of quetiapine-associated cardiac AEs based on an extensive analysis of a real-world, large-sample FAERS database, and prioritize cardiac AE signals.
基金:
National Natural Science Foundation of China [82104476]
第一作者单位:[1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
共同第一作者:
通讯作者:
通讯机构:[3]School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China[4]Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China[*1]Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1277 Jiefang Avenue, Wuhan 430022, China.[*2]School of Pharmaceutical Science and Technology, Tianjin University, No. 92 Weijin Road Nankai District, Tianjin, 300072, China
推荐引用方式(GB/T 7714):
Shu Yamin,Ding Yiling,Liu Lulu,et al.Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system[J].CNS NEUROSCIENCE & THERAPEUTICS.2023,29(9):2705-2716.doi:10.1111/cns.14215.
APA:
Shu, Yamin,Ding, Yiling,Liu, Lulu&Zhang, Qilin.(2023).Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system.CNS NEUROSCIENCE & THERAPEUTICS,29,(9)
MLA:
Shu, Yamin,et al."Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system".CNS NEUROSCIENCE & THERAPEUTICS 29..9(2023):2705-2716