Emerging and Established Adverse Events of Pasireotide: A Twelve-Year Pharmacovigilance Study.

Abstract

Objectives: This study aimed to provide a comprehensive assessment of pasireotide's real-world safety profile by analyzing adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS).

Methods: FAERS data from Q4 2012 to Q3 2024 were retrospectively analyzed using disproportionality methods, including the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Descriptive analyses evaluated clinical characteristics such as age, sex, country of report, and time to AE onset, while subgroup analyses assessed variations in AE occurrence across demographic groups.

Results: A total of 7892 pasireotide-related AEs were identified across 27 system organ classes. Frequently reported AEs included hyperglycemia, cholelithiasis, and gastrointestinal disturbances, with hyperglycemia being the most common. Emerging safety signals were identified, including nephrolithiasis, sudden hearing loss, ptosis, and atrioventricular block. Subgroup analyses indicated that metabolic AEs were more prevalent in females, while males reported higher rates of gastrointestinal symptoms. Older patients were more susceptible to cardiovascular AEs.

Conclusions: This study underscores the need for ongoing pharmacovigilance to detect both established and emerging AEs associated with pasireotide. Implementing personalized monitoring strategies based on demographic factors such as age and sex can help mitigate risks and optimize treatment outcomes, enhancing patient safety in clinical practice.