Comparative Safety of Empagliflozin in Routine Care Patients: Interim Results from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study

In the EMPA-REG OUTCOME trial empagliflozin (EMPA) reduced the risk of cardiovascular death, all-cause mortality, and hospitalization for heart failure in patients with type 2 diabetes (T2D) and established cardiovascular disease. The comparative safety of EMPA in routine care is yet to be established. EMPRISE studies the effectiveness, safety and healthcare utilization of EMPA, based on data from Medicare and 2 U.S. commercial claims datasets (2014-2019). In an interim analysis using data from 2014-2018 (2014-2017 in Medicare), we identified 55,580 pairs of 1:1 propensity score-matched patients ≥18 years with T2D initiating EMPA or a DPP4 inhibitor (DPP4i). Safety outcomes of interest included lower-limb amputations (LLA), bone fractures, diabetic ketoacidosis hospitalization (DKA), and acute kidney injury hospitalization (AKI). We estimated pooled HR and RD/1000 PY with their 95% CI adjusting for >140 baseline covariates. Over a mean follow up of 6.3 months, EMPA initiators had similar risk of LLA and fractures, an increased risk of DKA [HR, 2.01 (1.37-2.95); RD, 1.44 (0.72,2.17) per 1000 PY], and a decreased risk of AKI [HR, 0.66 (0.59-0.74); RD, -8.59 (-10.93,-6.25) per 1000 PY], compared with DPP4i (Table). In routine care, the initiation of EMPA was associated with a safety profile in line with documented information.View largeDownload slideView largeDownload slide DisclosureE. Patorno: Research Support; Self; Boehringer Ingelheim International GmbH, National Institutes of Health. S. Schneeweiss: Other Relationship; Self; Aetion. H. Tesfaye: None. D. J. Wexler: Board Member; Self; Novo Nordisk. R. Glynn: Research Support; Self; AstraZeneca, Kowa Research Institute, Inc., Novartis AG, Pfizer Inc. M. Najafzadeh: None. L. G. Bessette: Consultant; Self; Aetion, Inc. H. Zakoul: None. L. Koeneman: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. A. Deruaz-luyet: Employee; Self; Boehringer Ingelheim (Canada) Ltd., Employee; Spouse/Partner; Sanofi-Aventis Deutschland GmbH.