134-LB: Effectiveness and Safety of Empagliflozin in Routine Care Patients: Interim Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study

EMPRISE studies the effectiveness, safety and healthcare utilization of empagliflozin (EMPA), using data from Medicare and 2 U.S. commercial claims datasets (2014-2019). In an interim analysis on data from 2014-2017, we identified 39,169 pairs of 1:1 propensity score-matched patients ≥18 years with type 2 diabetes initiating EMPA or a DPP-4 inhibitor (DPP-4i). Effectiveness outcomes of interest were HHF [defined as a HF discharge diagnosis in the primary (HHF-Specific) or in any position (HHF-Broad)], a composite of MI and stroke, and all-cause mortality (Medicare only). Safety outcomes were lower-limb amputations (LLA), bone fractures, diabetic ketoacidosis (DKA), and acute kidney injury (AKI). We estimated pooled HR and 95% CI adjusting for >140 baseline covariates. Compared to DPP-4i, EMPA had a reduced risk of HHF [HHF-Specific: 0.46 (0.30-0.73); HHF-Broad: 0.63 (0.51-0.77)], a similar risk of MI or stroke [HR (95% CI) = 0.89 (0.73-1.09)], and a reduced risk of all-cause mortality [0.52 (0.36-0.76) in Medicare. Over a mean follow up of 178 days, EMPA was associated with a decreased risk of AKI [(0.64 (0.53-0.77)], an increased risk of DKA [1.56 (1.00-2.44)], and a similar risk of LLA and fractures (Table 1). In routine care, EMPA had an effectiveness profile consistent with RCT findings and safety outcomes in line with documented information. Disclosure E. Patorno: Other Relationship; Self; Boehringer Ingelheim International GmbH. A. Pawar: None. L.G. Bessette: None. J. Franklin: None. M. Najafzadeh: None. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. A. Deruaz-Luyet: Employee; Self; Boehringer Ingelheim International GmbH. Employee; Spouse/Partner; Sanofi-Aventis Deutschland GmbH. K. Brodovicz: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Schneeweiss: None. Funding Boehringer Ingelheim