127-LB: Effectiveness and Safety of Empagliflozin in Routine Care in Europe and East Asia: Results from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study

Abstract

The EMPRISE study evaluates the effectiveness and safety of empagliflozin (EMPA) in a broader population of patients with T2D in routine clinical care across countries. The study included 67,140 pairs of 1:1 propensity score matched (PSM) patients ≥18 years with T2D newly initiating EMPA or any DPP-4i from large databases/registers in Israel, Finland, Germany, Spain, Sweden, South Korea, Taiwan and Japan. Mostly, PSM used 100+ baseline covariates (Table), and pooled HR with 95% CI were computed using random-effects meta-analysis models. EMPA compared to DPP-4i (Table), was associated with 27-47% lower risk of hospitalization for heart failure (HHF), stroke, all-cause mortality (ACM), and two composite outcomes: HHF & ACM; and myocardial infarction, stroke & ACM. Safety analyses associated EMPA with 46% lower risk of acute kidney injury requiring dialysis. EMPRISE study results showed that EMPA is associated with reduced risk of cardiovascular (CV) disease, incl HHF, in patients with T2D in routine clinical care settings in Israel, Europe and East Asia. These results complement the results from clinical trial EMPA-REG OUTCOME®, and are in line with the ADA/EASD 2019 consensus update to prescribe SGLT-2i for patients with T2D and high-risk, vascular or chronic kidney disease or heart failure to reduce HHF and major adverse CV events/deaths. Disclosure A. Karasik: Advisory Panel; Self; Boehringer Ingelheim International GmbH. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk A/S. S. Lanzinger: None. E. C. H. Tan: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. D. Yabe: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Corporation. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., MDS Co., Ltd., Novo Nordisk Pharma Ltd. D. Kim: None. W. Sheu: None. C. Melzer Cohen: None. R. W. Holl: None. K. Ha: None. T. Nystrom: Board Member; Self; Abbott, Lilly Diabetes, Sanofi. Research Support; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; AstraZeneca. L. K. Niskanen: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Sanofi-Aventis. Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk. Stock/Shareholder; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Linnemann Jensen: Stock/Shareholder; Self; Novo Nordisk A/S. M. H. Kyaw: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. J. Nunez: Advisory Panel; Self; Novo Nordisk Pharma Ltd. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc.