Signal analysis of adverse drug event related to cardiac disorders in cinacalcet and etelcalcetide:a pharmacovigilance study
AIM To mining the signals of adverse drug event(ADE)related to cardiac disorders(CRADE)in cinacalcet and etelcalcetide,and provide reference for clinical medicine safety.METHODS ADE reports of cinacalcet and etelcalcetide from the first quarter of 2013 to the first quarter of 2023 in the FDA adverse event reporting system were collected.CRADE signals of cinacalcet and etelcalcetide were detected by frequency method.The frequency and signal intensity of CRADE,and the relationship to course of treatment and therapeutic dose were analyzed.RESULTS A total of 13 136 477 ADE reports were included,and the CRADE reports of cinacalcet and etelcalcetide were 631 and 327,respectively.Two new signals of cardiac arrest and angina pectoris were found in the signal mining of CRADE of the two drugs.Aortic stenosis and coronary stenosis were two additional new signals for etelcalcetide.The signal intensity of each CRADE of cinacalcet was generally lower than that of etelcalcetide.Among etelcalcetide CRADE,aortic stenosis and unstable angina showed stronger signals,with reported odds ratio of 259.307 and 179.621,respectively,which were much higher than that of other CRADE.When the dose of cinacalcet was 30 mg·d-1,the frequency of CRADE was higher.CRADE was reported more frequently when the course of medication was longer than 8 weeks.CONCLUSION New CRADE signals of cinacalcet and etelcalcetide have been found.It is necessary to pay attention to the safety of therapeutic drugs when using cinacalcet for a long course of treatment,or when using etecalcetide in patients with cardiovascular disease.
cinacalcetetelcalcetideadverse drug eventspharmacovigilancedata mining
万方数据
维普
