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• W4387249010 abstract "SESSION TITLE: Critical Care Posters 18 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/11/2023 12:00 pm - 12:45 pm PURPOSE: Though sodium-glucose transport protein 2 (SGLT2) inhibitors and their association with euglycemic diabetic ketoacidosis (DKA) is now known, patient-specific risk factors are still relatively unknown. Along with posing a diagnostic challenge, this gap has added to a delay in diagnosis. It is also unclear if euglycemic DKA poses a mortality risk independent of the risk from DKA. METHODS: An observational, retrospective and pharmacovigilance study based on the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) database was performed between January 2017 and December 2022. Euglycemic DKA was identified using the terminology in Medical Dictionary for Regulatory Activities (MedDRA) classification. The three FDA-approved SGLT2 agents available in the US (canagliflozin, empagliflozin and dapagliflozin) were included in the analysis. AE association was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). The ROR was considered significant when the lower limit of the 95% CI was >1.0. RESULTS: There were 2, 183 drug-induced DKA (0.02%) from a total of 13, 009, 269 events reported in the FAERS database from 2013-2022. Of these, 90.7% (n=1, 979) have been linked to SGLT2 inhibitors. The most frequently associated agent was empagliflozin (61.8% of all reported AE, n=1,223). Most cases were noted in patients aged 18-64 years (n=1,161; 58.7%), and 25.7% were in older adults (≥65 years). Interestingly, both male and female sex (47.4% and 44.3%) had similar rates of SGLT2 inhibitors-induced euglycemic DKA, and not specified in 8.2% (n=163). Most cases (59.5%) were reported in the years 2020 and 2021. Of the 1, 979 reported AE included here, events were life-threatening and / or resulted in hospitalization in 1, 966. The mortality rate was 2.4% (n=47). ROR for all SGLT2 inhibitor-induced euglycemic DKA was remarkably high at 2711.13 ( 2346.57 – 3132.34. Individual SGLT2 inhibitor rates were not calculated. CONCLUSIONS: Up to 90% of all drug induced euglycemic DKA was associated with SGLT2 inhibitors. This was further confirmed by the remarkably elevated ROR suggesting a strong causality. Among the SGLT2 inhibitor-induced DKA, most were middle-aged (between 18-64 years) and did not have sex-specific outcomes. Though most required hospitalization, mortality rates were low and is likely comparable to the risk of non-euglycemic DKA. There has been an increase in the cases of euglycemic DKA in the past years, and this is consistent with the increased prescribing indications as well. CLINICAL IMPLICATIONS: Euglycemic DKA from SGLT2 inhibitors was more common in middle-ages and most patients required hospitalization. Mortality was approximately 2.5% based on our preliminary analysis of the FAERS database. DISCLOSURES: No relevant relationships by Michael Gurell No relevant relationships by Vidisha Master No relevant relationships by Saarwaani Vallabhajosyula" @default.
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• W4387249010 date "2023-10-01" @default.
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• W4387249010 title "CLINICAL IMPACT OF SGLT2 INHIBITORS AND EUGLYCEMIC DIABETIC KETOACIDOSIS: INSIGHTS FROM THE FAERS DATABASE" @default.
• W4387249010 doi "https://doi.org/10.1016/j.chest.2023.07.1206" @default.
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