Pharmacovigilance Analysis of Adverse Event Characteristics and the Neuropsychiatric Safety Associated with Sacubitril/Valsartan Based on the FAERS Database

This study conducted research on data mining and analysis of post-marketing adverse events related to the neuropsychiatric safety of Sacubitril/Valsartan using the FDA Adverse Event Reporting System (FAERS) database. The goal was to provide guidance for the safe clinical use of Sacubitril/Valsartan. By retrieving relevant reports from Q3 2015 to Q4 2023 and applying Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods for signal detection, we found that Sacubitril/Valsartan, in addition to known common adverse reactions (such as hypotension, hyperkalemia, cough, and vertigo), Sacubitril/Valsartan may also be associated with a range of rare neurological and psychiatric symptoms, including memory impairment, cerebrovascular accidents, stress, and amnesia. A total of 19,688 cases of neuropsychiatric adverse events were attributed to Sacubitril/Valsartan, accounting for 22.20% of all reported adverse events. These adverse events were particularly prevalent among elderly patients. Among the adverse neuropsychiatric events, there were 226 deaths (3.53%), with 17 out of 37 neuropsychiatric symptom-related Preferred Terms (PTs) associated with death as an outcome. This study highlights the importance of closely monitoring the neuropsychiatric safety of patients treated with Sacubitril/Valsartan and provides new insights into the broader safety profile of this medication. However, as this analysis is based on a spontaneous reporting system, which may be subject to reporting bias and inaccuracies, therefore, these findings require further clinical research is necessary to validate these findings.