Data Mining And Analysis Of Adverse Reactions Of ACEI Drugs Based On FAERS Database

Objective: Based on the FAERS database,through the safety revaluation of the adverse drug reaction data of ACEI drugs after marketing,we found new risk signals,promoted the rational use of ACEI drugs,and provided reference for clinical safe drug use.Method: The adverse event reports of captopril,benazepril,enalapril,perindopril and lisinopril were collected from FAERS database of FDA from the first quarter of 2004 to the first quarter of 2020.The above ADE reports were statistically described from the perspectives of annual reporting trend,gender and age of patients,and clinical outcomes.The safety signals of the above drugs were detected by ROR and PRR methods,and the key organs and high-risk signals were analyzed.Result:(1)The number of ADE reported from high to low was lisinopril,enalapril,benazepril,perindopril and captopril.The number of ADE reports of the five drugs approved for marketing showed the same trend with years.In the aspect of gender,women were more likely to receive captopril and benazepril than men,while men were more likely to receive enalapril,perindopril and lisinopril.In terms of age distribution of ADE reports,the distribution of the five drugs is generally consistent,with the highest proportion of people aged 45-64 and the lowest proportion of people under 18.In the aspect of clinical outcomes reported by ade,death and hospitalization were the main causes of the five drugs.(2)At the system organ(SOC)level,the distribution of ADR signals mined by captopril,benazepril,enalapril,perindopril and lisinopril is roughly the same,and most of them focus on the four SOC classifications of vascular and lymphatic diseases,heart organ diseases,changes of examination indexes and gastrointestinal diseases.Among them,the SOC with the most signal concentration of captopril ADR was heart organ disease,with 83signals;the SOC with the most signal concentration of benazepril ADR was the change of examination index,with 104 signals;the SOC with the most signal concentration of enalapril ADR was the change of examination index,with 185 signals;the SOC with the most signal concentration of perindopril ADR was the change of examination index,with 104 signals;the SOC with the most signal concentration of lisinopril ADR was the change of examination index,with 104 signals The most SOC in ADR signal set was the change of inspection index,and the number of signal was192.(3)Two,one,nine,twenty,and fifty sex difference signals of captopril,benazepril,enalapril,perindopril,and lisinopril were detected by ror.For male patients,captopril(ROR=0.41,P=0.001),benazepril(ROR=0.47,P=0.000),enalapril(ROR=0.36,P=0.000)and lisinopril(ROR=0.16,P=0.000)all indicated that coronary heart disease was a high-risk ADR signal,and lisinopril was easy to induce vascular edema(ROR=0.36,P=0.000);for female patients,For female patients,enalapril(ROR=3.08,P=0.000)and perindopril(ROR=6.00,P=0.001)simultaneously detected high-risk ADR signals of urinary tract infection.Perindopril could induce lactic acidosis(ROR=8.69,P=0.000)and hypoglycemia(ROR=4.60,P=0.000).Benazepril had no ADR signal.Conclusion:(1)There was no significant difference in sex,age and clinical outcome of ADE among ACEI drugs.However,the risk of adverse reactions in female patients is higher than that in male patients,and individual differences should be paid attention to in clinical medication.(2)The common adverse reaction signals of ACEI drugs are widely distributed in various organs and systems.Vascular and lymphatic diseases,heart organ diseases,changes of examination indexes and gastrointestinal diseases should be focused on,At the same time,we should give a high degree of warning to the new ADR signals which are not reported in the literature and instructions.(3)Data mining based on FAERS adverse event database can quickly detect adverse reaction signals,provide the basis for signal verification and evaluation,and provide reference for clinical rational drug use.