Ketoacidosis associated with type 2 sodium-glucose cotransporter inhibitors (SGLT2i) in patients aged 65 and older: Evidence from the French national pharmacovigilance database
Authors' conclusion
This study highlights the clinical characteristics and risk factors of SGLT2i-associated DKA in older adults. Infections and severe acidosis were key predictors of ICU admission. The findings underscore the importance of careful patient selection and monitoring to mitigate DKA risk in older patients receiving SGLT2i therapy.
Study context
- Population
- Patients aged ≥65 years with diabetic ketoacidosis (DKA) reported with SGLT2i use, French pharmacovigilance database, cases from 2020 onwardcases analysed
- Participants
- 55 patients
- Outcome
- Characteristics of SGLT2i-associated DKA cases
Methodological detailsFrench national pharmacovigilance database
- French national pharmacovigilance database
Main finding
As reported in the abstract
- Median age, years (IQR 69.0; 77.5)
- 74.0
- Males
- 63.4 %
- Median Charlson comorbidity index (IQR 6.0; 10.0)
- 8.0
- Median drugs per patient
- 9
- Precipitating factor: infections
- 36.4 %
- Precipitating factor: dehydration
- 20.0 %
- Precipitating factor: fasting
- 18.2 %
- Hospitalization
- All cases
- Intensive care unit (ICU) admission
- 36.4 %
- Orotracheal intubation and/or vasopressors among ICU patients
- 35.0 %
- Death
- 1 (1.8 %)
Observational data: associations, not effects.
Further findings
Factors associated with ICU admission
- Younger age (71.3 vs. 75.4 years)
- P = 0.009
- Lower pH at admission
- P = 0.003
- Infection as precipitating factor
- P = 0.007
Original publication
Ketoacidosis associated with type 2 sodium-glucose cotransporter inhibitors (SGLT2i) in patients aged 65 and older: Evidence from the French national pharmacovigilance database. Diabetes Metab. Published 18 August 2025. doi:10.
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