Post‐authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycaemic agents in a Medicare and Medicaid population
Authors' conclusion
Ertugliflozin was associated with a higher risk of DKA relative to comparators. HRs were higher among new users with no-concomitant insulin use than those with concomitant insulin use. Results were consistent with prior SGLT2i data and highlighted the importance of caution by both patients and physicians.
Study context
- Population
- Patients with T2D in Medicare and Medicaid fee-for-service claims (Innovation in Medical Evidence and Development Surveillance network)two propensity score (PS)-matched cohorts
- Exposure
- Ertugliflozin vs sulfonylureas (SU)/thiazolidinediones (TZD) and vs incretin-based drugs
- SU/TZDn = 42,907reference
- Incretin-based drugsn = 42,247reference
- Outcome
- Principal hospital discharge diagnosis for diabetic ketoacidosis (DKA)
Methodological detailspost-authorization safety study, new-user design, 1:1 propensity score matched, Medicare and Medicaid claims
- Post-authorization safety study
- New-user design
- 1:1 propensity score matched
- Medicare and Medicaid claims
Main finding
As reported in the abstract
DKA
Hazard ratio (95% CI)
Ertugliflozin vs SU/TZDertugliflozin n = 42,907; DKA 2.95vs 1.49 per 1000 PY
1.88(1.17–3.02)
Ertugliflozin vs Incretin-based drugsertugliflozin n = 42,247; DKA 2.76vs 1.06 per 1000 PY
2.40(1.40–4.11)
Observational data: associations, not effects.
Further findings
| Outcome | Estimate | |
|---|---|---|
| DKA by baseline insulin use, vs SU/TZDErtugliflozinvs SU/TZD | HR (non-insulin users) 2.34 (95% CI 1.27–4.31) | |
| DKA by baseline insulin use, vs SU/TZDErtugliflozinvs SU/TZD | HR (insulin users) 1.17 (95% CI 0.54–2.52) | |
| DKA by baseline insulin use, vs incretin-based drugsErtugliflozinvs Incretin-based drugs | HR (non-insulin users) 2.84 (95% CI 1.42–5.66) | |
| DKA by baseline insulin use, vs incretin-based drugsErtugliflozinvs Incretin-based drugs | HR (insulin users) 1.87 (95% CI 0.79–4.46) | |
| 0.20.5125Ratio (log scale) |
Original publication
Post‐authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycaemic agents in a Medicare and Medicaid population. Diabet Med. Published 9 February 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →