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Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study.

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posted on 2024-01-23, 11:26 authored by Avraham Karasik, Stefanie Lanzinger, Elise Chia-Hui Tan, Daisuke Yabe, Dae Jung Kim, Wayne H-H Sheu, Cheli Melzer-Cohen, Reinhard W Holl, Kyoung Hwa Ha, Kamlesh Khunti, Francesco Zaccardi, Anuradhaa Subramanian, Krishnarajah Nirantharakumar, Thomas Nyström, Leo Niskanen, Majken Linnemann Jensen, Fabian Hoti, Riho Klement, Anouk Déruaz-Luyet, Moe H Kyaw, Lisette Koeneman, Dorte Vistisen, Bendix Carstensen, Sigrun Halvorsen, Gisle Langslet, Soulmaz Fazeli Farsani, Elisabetta Patorno, Júlio Núñez, EMPRISE Europe and Asia Study Group

Background

Continued expansion of indications for sodium-glucose cotransporter-2 inhibitors increases importance of evaluating cardiovascular and kidney efficacy and safety of empagliflozin in patients with type 2 diabetes compared to similar therapies.

Methods

The EMPRISE Europe and Asia study is a non-interventional cohort study using data from 2014-2019 in seven European (Denmark, Finland, Germany, Norway, Spain, Sweden, United Kingdom) and four Asian (Israel, Japan, South Korea, Taiwan) countries. Patients with type 2 diabetes initiating empagliflozin were 1:1 propensity score matched to patients initiating dipeptidyl peptidase-4 inhibitors. Primary endpoints included hospitalization for heart failure, all-cause mortality, myocardial infarction and stroke. Other cardiovascular, renal, and safety outcomes were examined.

Findings

Among 83,946 matched patient pairs, (0·7 years overall mean follow-up time), initiation of empagliflozin was associated with lower risk of hospitalization for heart failure compared to dipeptidyl peptidase-4 inhibitors (Hazard Ratio 0·70; 95%CI 0.60 to 0.83). Risks of all-cause mortality (0·55; 0·48 to 0·63), stroke (0·82; 0·71 to 0·96), and end-stage renal disease (0·43; 0·30 to 0·63) were lower and risk for myocardial infarction, bone fracture, severe hypoglycemia, and lower-limb amputation were similar between initiators of empagliflozin and dipeptidyl peptidase-4 inhibitors. Initiation of empagliflozin was associated with higher risk for diabetic ketoacidosis (1·97; 1·28 to 3·03) compared to dipeptidyl peptidase-4 inhibitors. Results were consistent across continents and regions.

Interpretation

Results from this EMPRISE Europe and Asia study complements previous clinical trials and real-world studies by providing further evidence of the beneficial cardiorenal effects and overall safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors.

Funding

Boehringer Ingelheim and Lilly Diabetes Alliance

History

Author affiliation

Diabetes Research Centre, University of Leicester

Version

  • VoR (Version of Record)

Published in

Diabetes & metabolism

Volume

49

Issue

2

Pagination

101418

Publisher

Elsevier BV

issn

1262-3636

eissn

1878-1780

Copyright date

2023

Available date

2024-01-23

Spatial coverage

France

Language

eng

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