A real-world pharmacovigilance study of sacubitril\valsartan in older people: data mining of the FDA adverse event reporting system.

Abstract

Background: Sacubitril\valsartan is widely used in the clinical management of heart failure with reduced ejection fraction and hypertension. This study aims to systematically investigate and quantify the safety signals and potential risks associated with sacubitril\valsartan in individuals aged 65 and older, leveraging data from the FAERS database to provide insights into its real-world safety profile.

Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of Sacubitril\valsartan-associated AEs in elderly.

Results: The search retrieved 94,210 sacubitril\valsartan-associated cases within the reporting period; 86 PTs with significant disproportionality were retained in 65 + . Reports emerged for several cognitive-related AEs and several fragility acceleration AEs, which were rare. Unexpected safety signals such as 'Injury, poisoning, and procedural complications' were only detected in 65 + . Most of the cases occurred within the first month after sacubitril\valsartan initiation, and this was consistent across age groups.

Conclusions: Our study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of Sacubitril\valsartan in elderly.