TRENDS IN DIABETIC KETOACIDOSIS INCIDENCE AMONG NEW USERS OF SGLT2 INHIBITORS FOLLOWING EXPANDED INDICATIONS, 2020-2023
Author(s)
Sunny Park, PharmD, Scott Micek, PharmD.
St. Louis Center for Outcomes Research and Education, University of Health Sciences and Pharmacy, Saint Louis, MO, USA.
St. Louis Center for Outcomes Research and Education, University of Health Sciences and Pharmacy, Saint Louis, MO, USA.
OBJECTIVES: As sodium glucose cotransporter-2 inhibitors (SGLT2i) use broadens beyond type 2 diabetes, the impact on safety, such as diabetic ketoacidosis (DKA), is unclear. This study quantified DKA incidence among new SGLT2i users in U.S. claims data and evaluated trends in exposure, indications, and risk.
METHODS: We conducted a retrospective cohort study using administrative claims database (Jan 2020-June 2024). New SGLT2i users were adults with ≥12 months of pre-index continuous enrollment and no SGLT2i fills. Follow-up extended up to 12 months and was censored at the first DKA event which was captured using ICD-10 codes. The primary outcome was DKA incidence per 1,000 person-years by calendar year. Secondary outcomes included time-to-DKA and SGLT2-i indication(s) in patients with a DKA event.
RESULTS: Across 613,376 new users, use increased over time, from 98,996 new users in 2020 to 127,675 in 2021, 244,943 in 2022, and 141,762 in 2023 (first 6 months). Average monthly new use increased year-over-year by 29% (2020-2021), 92% (2021-2022), and 16% (2022-2023), with an overall increase of 186% from 2020-2023.
7,364 (1.2%) patients experienced DKA. The median time to first DKA event was 132 days (IQR 47-240). Annual DKA incidence rates were 11.92 per 1,000 PY in 2020, 14.12 in 2021, 14.02 in 2022, and 13.04 in 2023. Among patients with DKA events, 61% had diabetes, 37% multiple indications, <1% heart failure or CKD and 82% of patients had SGLT2i exposure at the time of DKA.
CONCLUSIONS: Despite significantly increased SGLT2i use, annual DKA incidence rates remained stable over the evaluation period. Over half of DKA events occurred during periods of active SGLT2i exposure. As SGLT2i use expands to broader patient populations, continued real-world monitoring of DKA risk remains important for safe use.
METHODS: We conducted a retrospective cohort study using administrative claims database (Jan 2020-June 2024). New SGLT2i users were adults with ≥12 months of pre-index continuous enrollment and no SGLT2i fills. Follow-up extended up to 12 months and was censored at the first DKA event which was captured using ICD-10 codes. The primary outcome was DKA incidence per 1,000 person-years by calendar year. Secondary outcomes included time-to-DKA and SGLT2-i indication(s) in patients with a DKA event.
RESULTS: Across 613,376 new users, use increased over time, from 98,996 new users in 2020 to 127,675 in 2021, 244,943 in 2022, and 141,762 in 2023 (first 6 months). Average monthly new use increased year-over-year by 29% (2020-2021), 92% (2021-2022), and 16% (2022-2023), with an overall increase of 186% from 2020-2023.
7,364 (1.2%) patients experienced DKA. The median time to first DKA event was 132 days (IQR 47-240). Annual DKA incidence rates were 11.92 per 1,000 PY in 2020, 14.12 in 2021, 14.02 in 2022, and 13.04 in 2023. Among patients with DKA events, 61% had diabetes, 37% multiple indications, <1% heart failure or CKD and 82% of patients had SGLT2i exposure at the time of DKA.
CONCLUSIONS: Despite significantly increased SGLT2i use, annual DKA incidence rates remained stable over the evaluation period. Over half of DKA events occurred during periods of active SGLT2i exposure. As SGLT2i use expands to broader patient populations, continued real-world monitoring of DKA risk remains important for safe use.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH10
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)