249-OR: Empagliflozin Selected Cardiovascular and Safety Outcomes in Routine Care: First Results from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study

Abstract

EMPRISE studies the effectiveness, safety and healthcare utilization of empagliflozin (EMPA), a SGLT2 inhibitor, using data from Medicare and 2 U.S. commercial claims datasets (2014-2019). In an analysis on data from 2014-2016, we identified 17,551 pairs of 1:1 propensity score-matched patients ≥18 years with type 2 diabetes initiating EMPA or a DPP-4 inhibitor (DPP-4i). We assessed a composite CV outcome (MI, stroke, or all-cause mortality) and an extended CV outcome (plus heart failure hospitalization or coronary revascularization). Safety outcomes of interest were lower-limb amputations, bone fractures, diabetic ketoacidosis (DKA), and acute kidney injury. We estimated pooled HR and 95% CI adjusting for >140 baseline covariates. Compared to DPP-4i, EMPA was associated with a trend to lower risk of the CV outcome [HR (95% CI) = 0.82 (0.62-1.10)], and a lower risk of the extended CV outcome [0.73 (0.60-0.88)], heart failure hospitalization [0.56 (0.43-0.73)]. Risk of safety outcomes were in line with current evidence despite small numbers, Table 1. We observed a numerical increase in DKA risk [1.74 (0.84-3.58)]. Early findings from EMPRISE showed that compared with DPP-4i, EMPA was associated with a lower risk of CV outcomes with varying levels of precision, and a safety profile consistent with currently documented information. Disclosure E. Patorno: Research Support; Self; National Institute on Aging. Other Relationship; Self; Boehringer Ingelheim International GmbH. A. Pawar: None. J. Franklin: Research Support; Self; U.S. Food and Drug Administration. M. Najafzadeh: Consultant; Self; Epigenomics. A. Deruaz-Luyet: Employee; Self; Boehringer Ingelheim International GmbH. Employee; Spouse/Partner; Medtronic, Sanofi. K. Brodovicz: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Sambevski: Employee; Self; Boehringer Ingelheim International GmbH. L.G. Bessette: None. M. Kulldorff: None. S. Schneeweiss: Consultant; Self; Aetion, WHISCON, LLC. Funding Boehringer Ingelheim