Signal Mining of Adverse Events Induced by Mineralocorticoid Receptor Antagonists Based on FAERS
Objective To promote the safe use of mineralocorticoid receptor antagonists(MRAs)in clinical practice.Methods The adverse drug event(ADE)reports induced by three MRAs(spironolactone,eplerenone,finerenone)reported from the first quarter of 2018 to the first quarter of 2023 in the FDA Adverse Event Reporting System(FAERS)were extracted.The systematic organ classification(SOC)and preferred term(PT)in the Medical Dictionary for Regulatory Activities were used for classification,the ADE signals were mined and analyzed by the reporting odds ratio(ROR)and the Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard methods.Results A total of 35 908 ADE reports were obtained with the above three MRAs as the primary suspected drugs,including 27 792 reports of spironolactone,6 734 of eplerenone and 1 382 of finerenone.A total of 5 930 patients were involved,including 4 455 cases of spironolactone,1 052 of eplerenone and 423 of finerenone;the proportions of males and females were comparable(49.45%vs.50.55%),the majority of patients were over 65 years(49.07%).ADEs were reported mainly by physicians(35.48%)and consumers(24.74%),mainly from the United States(37.37%),and the patients using oral dosage forms were the most(47.89%).A total of 467 ADE signals were generated at the PT level,including 312 of spironolactone,136 of eplerenone,and 19 of finerenone,involving hyperkalemia,acute kidney injury,hyponatremia,and decreased jugular venous pressure,etc.A total of 26 SOCs were involved,including 26 of spironolactone,20 of eplerenone,and eight of finerenone,involving metabolic and nutritional diseases,kidney and urinary system diseases,heart organ diseases,various examinations,etc.Conclusion The common ADE signals and the involved systems/organs of MRAs are basically consistent with those in the corresponding drug instruction,but we should be alert to the ADEs not recorded in drug instruction,such as congenital bulbar muscular atrophy,chronic heart failure,elevated jugular vein pressure,myalgia,etc.
mineralocorticoid receptor antagonistspironolactoneeplerenonefinerenoneadverse drug eventsignal miningreporting odds ratioMedicines and Healthcare Products Regulatory Agency comprehensive standard
万方数据
维普
