首页|基于FAERS数据库的PCSK9抑制剂和他汀类药物的高血糖不良反应分析

基于FAERS数据库的PCSK9抑制剂和他汀类药物的高血糖不良反应分析

扫码查看
目的:基于FDA不良事件报告系统(FDA Ad-verse Events Reporting System,FAERS),比较 PCSK9抑制剂和他汀类药物引起高血糖的风险。方法:利用FAERS数据库,收集2016年至2023年第3季度,首要怀疑药物为阿利西尤单抗、依洛尤单抗、阿托伐他汀、瑞舒伐他汀,不良事件为高血糖的报告,采用报告比值比法(ROR)评价PCSK9抑制剂和他汀类药物导致高血糖的风险大小。结果:根据FAERS数据库,与阿托伐他汀及瑞舒伐他汀相比,阿利西尤单抗发生高血糖的ROR(95%CI)分别为0。628(0。545,0。724)和 0。307(0。263,0。357);依洛尤单抗发生高血糖的ROR(95%CI)分别为0。817(0。750,0。889)和 0。399(0。361,0。441),均未产生不良反应信号。与其他所有药物相比,阿利西尤单抗和依洛尤单抗发生高血糖的ROR(95%CI)分别为 1。488(1。315,1。682)和 1。934(1。845,2。027),均产生不良反应信号。结论:基于FAERS数据库,PC-S K9抑制剂较他汀类药物引起高血糖的风险低,值得引起临床关注。
Analysis of hyperglycaemia adverse drug reactions of PCSK9 inhibi-tors and statins based on FAERS database
AIM:To compare the risk of hypergly-caemia with PCSK9 inhibitors versus statins,based on U.S.Food and Drug Administration Adverse Events Reporting System(FAERS).METHODS:The hyperglycaemia reports induced by"alirocumab","evolocumab","atorvastatin"and"rosuvastatin"were utilized as the first suspected drugs from the database of FAERS from 2016 to the third quarter of 2023.The report odd ratio(ROR)method was employed.RESULTS:Based on the FAERS database,the ROR(95%CI)for hyperglycaemia due to Ali-rocumab versus Atorvastatin and Rosuvastatin were 0.628(0.545,0.724)and 0.307(0.263,0.357),the ROR(95%CI)for hyperglycaemia due to Evoloc-umab were 0.817(0.750,0.889)and 0.399(0.361,0.441),all generated no adverse reaction signals.The ROR(95%CI)for hyperglycaemia due to Ali-rocumab and Evolocumab versus all other drugs in FAERS were 1.488(1.315,1.682)and 1.934(1.845,2.027),all generated adverse reaction signals,re-spectively.CONCLUSION:Based on the FAERS data-base,PCSK9 inhibitors have a lower risk of hyper-glycemia than statins and deserve clinical attention.

PCSK9 inhibitorsadverse events re-porting systemhyperglycaemiasignal mining

娄安琦、李全志、韩爽、朱思源、张威

展开 >

首都医科大学附属北京积水潭医院药学部,北京 100035

PCSK9抑制剂 不良事件报告系统 高血糖 信号挖掘

2024

中国临床药理学与治疗学
中国药理学会

中国临床药理学与治疗学

CSTPCD北大核心
影响因子:0.97
ISSN:1009-2501
年,卷(期):2024.29(7)