Abstract
Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II-receptor blockers (ARBs) are classified as renin-angiotensin system blockers. Angioedema is a serious adverse event caused by ACEIs. There have been fewer reports of angioedema associated with ARBs than with ACEIs. The Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) are widely used for pharmacovigilance. We analyzed the association of renin-angiotensin system blockers and angioedema in reports of the FAERS and JADER database, and classified type of ACEIs and ARBs in Weibull distribution. Reports for 13 ACEIs (lisinopril, ramipril, etc) and 7 ARBs (valsartan, losartan, etc) were analyzed. We evaluated the association between each drug and adverse event using the number of relevant reports, reporting ratio, and reporting odds ratio (ROR). FAERS contained 4,746,890 reports, and after excluding duplicate data, 3,522,995 reports were analyzed. The number of reports relating to angioedema was 215,569. The ROR of ACEIs and ARBs associated with angioedema was 2.3 (95% confidence interval [CI]: 2.3-2.3) and 1.8 (95% CI: 1.8-1.8), respectively. JADER contained 292,720 reports. The number of reports relating to angioedema was 6,764. The ROR of ACEIs and ARBs associated with angioedema was 1.5 (95%CI: 1.3-1.7) and 1.0 (95%CI: 1.0-1.1), respectively. The RORs indicate that angioedema is positively associated with both ACEIs and ARBs. ACEIs and ARBs are classified as early failure type in Weibull distribution. ACEIs and ARBs should be administered carefully with regard to angioedema.
