Emerging and Established Adverse Events of Pasireotide: A Twelve-Year Pharmacovigilance Study
Authors' conclusion
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.
Study context
- Population
- Pasireotide-related AE reports in the FDA Adverse Event Reporting System, Q4 2012 to Q3 20247,892 adverse events (AEs)
- Outcome
- Pasireotide-related AEs
Methodological detailsretrospective disproportionality analysis of FDA Adverse Event Reporting System (FAERS), disproportionality analysis (ROR, PRR, BCPNN, MGPS), subgroup analyses by demographics
- Retrospective disproportionality analysis of FAERS
- Disproportionality analysis (ROR, PRR, BCPNN, MGPS)
- Subgroup analyses by demographics
Main finding
As reported in the abstract
Pasireotide-related AEs identified
7892
System organ classes involved
27
Observational data: associations, not effects.
Further findings
AEs by demographic subgroup
- Metabolic AEs more prevalent in females; males reported higher rates of gastrointestinal symptoms
- Older patients more susceptible to cardiovascular AEs
Original publication
Emerging and Established Adverse Events of Pasireotide: A Twelve-Year Pharmacovigilance Study. Endocr Pract. Published 15 April 2025. doi:10. 1016/ j. eprac. 2025. 04. 005
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