Comparison of the pharmacovigilance signals of cardiac and renal adverse events associated with sacubitril/valsartan and valsartan alone based on the FAERS database.

Background: In clinical practice, cardiovascular and renal safety profiles of sacubitril/valsartan, compared with those of valsartan alone, remain controversial. Therefore, we aimed to compare the pharmacovigilance signals related to cardiovascular and renal adverse events between sacubitril/valsartan and valsartan alone using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Research design and methods: Raw report data on cardiac and renal adverse events associated with sacubitril/valsartan and valsartan alone were retrieved from the FAERS database using preferred terms from the Medical Dictionary for Regulatory Activities. Preferred terms were mapped to System Organ Classes, and the time to onset of adverse events associated with sacubitril/valsartan and valsartan alone was calculated.

Results: Most adverse events associated with sacubitril/valsartan occurred within the first month, whereas adverse events were more prevalent 6 months to 1 year after administration of valsartan alone. Adverse events reported for sacubitril/valsartan and valsartan alone included cardiac failure, cardiogenic shock, and ventricular fibrillation. Considering sacubitril/valsartan only, adverse events reported were renal impairment, renal failure, and acute kidney injury. For valsartan alone, adverse events reported included arrhythmia and angina pectoris.

Conclusions: Sacubitril/valsartan carries a higher renal safety risk and lower cardiac safety risk than valsartan alone.