Prolonged Diabetic Ketoacidosis Associated With Sodium–Glucose Cotransporter-2 Inhibitors: A Review of Postmarketing Cases
Authors' conclusion
Although KA is a well-known risk associated with SGLT2 inhibitors, this case series demonstrated the potential for prolonged or recurrent KA events with serious outcomes. These cases informed updates to FDA's prescribing information to inform prescribers of this risk.
Study context
- Population
- Adults with T2D receiving SGLT2i with prolonged or relapsed ketoacidosis (KA), persistent ketonemia, ketonuria and/or glucosuria, reported through July 26, 2022
- Participants
- 29 unique cases
- Outcome
- Prolonged or relapsed KA cases
Methodological detailsreview of postmarketing cases, Food and Drug Administration (FDA) Adverse Event Reporting System and medical literature
- Review of postmarketing cases
- FDA Adverse Event Reporting System and medical literature
Main finding
As reported in the abstract
- Unique cases of prolonged or relapsed KA, persistent ketonemia, ketonuria or glucosuria
- 29
- Age range
- 26 to 85 years
- Treatment duration of KA
- 3 to 20 days
- Cases of relapsed KA when insulin was reduced or transitioned to subcutaneous route
- 7
- Patients with arterial pH 7.0 or below
- 4
- Median pH
- 7.1
- Taking 3 or more glycemic control medications incl. the SGLT2i
- 62%
Observational data: associations, not effects.
Original publication
Prolonged Diabetic Ketoacidosis Associated With Sodium–Glucose Cotransporter-2 Inhibitors: A Review of Postmarketing Cases. Endocr Pract. Published 29 April 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →