Post-marketing safety monitoring of sodium-glucose cotransporter 2 inhibitors for diabetes in cats: a pharmacovigilance study based on the FDA ADAE database.

چکیده اصلی

BACKGROUND: Bexagliflozin and velagliflozin are currently the only sodium-glucose cotransporter 2 inhibitors approved by the United States Food and Drug Administration (FDA) for treating diabetes in cats. There are limited real-world safety reports on their associated adverse events (AEs). HYPOTHESIS/OBJECTIVES: To analyze AEs associated with bexagliflozin and velagliflozin using real-world data from the FDA Animal Drug Adverse Events (ADAE) database. ANIMALS: None. METHODS: AE reports submitted for cats receiving bexagliflozin and velagliflozin. Data were obtained from the ADAE database up to the second quarter of 2025. Disproportionality analysis was conducted employing four algorithms: the reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. RESULTS: Of the 34 187 AE reports for cats, 2876 were related to bexagliflozin and 2776 to velagliflozin. AEs associated with bexagliflozin spanned 22 system organ classes (SOCs), with stronger signals observed for weight fluctuation, glucosuria, and diabetic ketoacidosis. Velagliflozin-related AEs occurred in 19 SOCs, with higher RORs for ketonuria, hypochloremia, and acid-base disorders. Bexagliflozin was associated with stronger signals for DKA and ketosis, whereas velagliflozin showed stronger signals for ketonuria and hypochloremia. Velagliflozin-related AEs occurred earlier (median onset: 5 vs. 9 days), resolved more quickly (median duration: 8 vs. 14 days). CONCLUSIONS AND CLINICAL IMPORTANCE: This study provides a comprehensive safety profile of bexagliflozin and velagliflozin for diabetes in cats. These findings support veterinarians in implementing differentiated risk monitoring and individualized therapeutic decisions in the management of diabetes in cats.

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