Abstract 24: Diabetic Ketoacidosis in Patients with Type 2 Diabetes Treated with Sodium Glucose Co-transporter 2 Inhibitors versus Other Antihyperglycemic Agents: An Observational Study of Four US Administrative Claims Databases

Introduction: Diabetic ketoacidosis (DKA) is a serious acute metabolic complication of diabetes. Rare DKA events have occurred in patients taking sodium glucose co-transporter 2 inhibitors (SGLT2i). This study evaluated the risk of DKA in patients with type 2 diabetes mellitus (T2DM) taking SGLT2i versus other antihyperglycemic agents (AHAs) in clinical practice. Methods: This study, per protocol reviewed and approved by the European Medicines Agency, identified patients from 4 large US claims databases using broad and narrow definitions of T2DM; the broad definition captured all patients with a T2DM diagnosis and the narrow definition was intended to exclude T1DM misclassified as T2DM. DKA was identified from diagnosis codes in inpatient or emergency room claims. Eligible new users of SGLT2i and 7 groups of AHA comparators were matched (1:1) on exposure propensity scores (PS) to adjust for imbalances in baseline covariates. Cox proportional hazard models conditioned on PS-matched pairs were used to estim...