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.


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.


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