Mining and evaluation of post-marketing adverse event signals of seven GLP-1RAs based on FAERS database
Objective Based on the FDA Adverse Event Reporting System(FAERS)database,to mine and analyze the adverse drug events(ADE)associated with seven glucagon-like peptide 1 receptor agonists(GLP-1RAs)to provide reference for the safe use of drugs in the clinic and to promote the monitoring of ADEs and the safe and rational use of GLP-1RAs.Methods The ADE reports of exenatide,liraglutide,lixisenatide,albiglutide,dulaglutide,semaglutide and tirzepatide were extracted from the FAERS database from January 2004 to September 2023,and were systematically categorised by using the Medical Dictionary for Regulatory Activities(MedDRA).The screened ADEs were systematically summarised using the MedDRA,and then the above ADEs were subjected to signal mining and analysed by the Reporting Odds Ratio method.Results A total of 217 259 ADE reports of the primary suspect drugs were extracted:77 366 for exenatide,35 951 for liraglutide,166 for lixisenatide,8 636 for albiglutide,60 398 for dulaglutide,19 975 for semaglutide,and 14 767 for tirzepatide.A total of 1 203 signals were obtained(51 for albiglutide,166 for dulaglutide,341 for exenatide,196 for liraglutide,68 for lixisenatide,271 for semaglutide and 110 for tirzepatide),which were related to 25 different System Organ Classes(SOC).The distribution of SOC corresponding to Preferred Term(PT)for ADEs associated with each GLP-1RAs was relatively consistent,with the total number of PTs concentrated in the systems of gastrointestinal disorders,systemic disorders and administration-site reactions,and various types of injuries poisonings and operational complications.Conclusion In this study,the differences and associations of ADEs among 7 GLP-1RAs were explored through signal mining to provide a reference for healthcare professionals and patients with a better understanding of relevant ADEs,which could enhance the monitoring of adverse reactions,detect serious and rare ADEs in a timely manner,and improve the safety of drug use.
glucagon-likepeptide-1receptor agonistssafetyadverse events signal mining
万方数据
维普
