Abstract
In the EMPA REG OUTCOME trial, empagliflozin (EMPA) reduced the risk of cardiovascular (CV) death, all-cause mortality, and hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) and established CV disease (CVD). We assessed the CV effectiveness of EMPA in real-world T2D patients with and without CVD within EMPRISE, a study on the effectiveness, safety and healthcare utilization of EMPA, based on Medicare and 2 U.S. commercial claims datasets (2014-2019). Using data from 2014-2018 (2014-2017 in Medicare), we identified 1:1 propensity score-matched patients ≥18 years with T2D initiating EMPA or a DPP4 inhibitor (DPP4i) with and without CVD (14,920 and 40,443 matched pairs). We assessed HHF, a composite of MI or stroke, an expanded atherosclerotic CV (ASCV) event (MI, stroke, unstable angina, or coronary revascularization), and death. We estimated pooled HR and RD with 95% CI adjusting for >140 covariates. Over a mean follow-up of 6.3 months, EMPA vs. DPP4i initiators with and without CVD had reductions in the risk of HHF [HR, 0.71 (0.60-0.84) and 0.55 (0.42-0.73)] and mortality [HR, 0.53 (0.37-0.76) and 0.46 (0.29-0.74)], with larger benefits in patients with CVD on an absolute risk scale as shown by RD, but similar risk of ASCV events, including MI or stroke (Table). EMPA was associated with risk reductions in HHF and mortality, but similar risk of ASCV events in patients with and without CVD. Disclosure E. 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. L. Zabotka: 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.
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