Incidence of diabetic ketoacidosis among patients with type 2 diabetes mellitus treated with SGLT2 inhibitors and other antihyperglycemic agents

Diabetes Res Clin Pract. 2017 Jun:128:83-90. doi: 10.1016/j.diabres.2017.04.004. Epub 2017 Apr 13.

Abstract

Aims: To estimate and compare incidence of diabetes ketoacidosis (DKA) among patients with type 2 diabetes who are newly treated with SGLT2 inhibitors (SGLT2i) versus non-SGLT2i antihyperglycemic agents (AHAs) in actual clinical practice.

Methods: A new-user cohort study design using a large insurance claims database in the US. DKA incidence was compared between new users of SGLT2i and new users of non-SGLT2i AHAs pair-matched on exposure propensity scores (EPS) using Cox regression models.

Results: Overall, crude incidence rates (95% CI) per 1000 patient-years for DKA were 1.69 (1.22-2.30) and 1.83 (1.58-2.10) among new users of SGLT2i (n=34,442) and non-SGLT2i AHAs (n=126,703). These rates more than doubled among patients with prior insulin prescriptions but decreased by more than half in analyses that excluded potential autoimmune diabetes (PAD). The hazard ratio (95% CI) for DKA comparing new users of SGLT2i to new users of non-SGLT2i AHAs was 1.91 (0.94-4.11) (p=0.09) among the 30,196 EPS-matched pairs overall, and 1.13 (0.43-3.00) (p=0.81) among the 27,515 EPS-matched pairs that excluded PAD.

Conclusions: This was the first observational study that compared DKA risk between new users of SGLT2i and non-SGLT2i AHAs among patients with type 2 diabetes, and overall no statistically significant difference was detected.

Keywords: Ketoacidosis; Sodium glucose co-transporter 2 (SGLT2) inhibitors; Type 2 diabetes mellitus.

MeSH terms

  • Cohort Studies
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetic Ketoacidosis / epidemiology*
  • Female
  • Humans
  • Hypoglycemic Agents / pharmacology
  • Hypoglycemic Agents / therapeutic use*
  • Incidence
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sodium-Glucose Transporter 2 Inhibitors*

Substances

  • Hypoglycemic Agents
  • Sodium-Glucose Transporter 2 Inhibitors