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.

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. KyawLisette Koeneman, Dorte Vistisen, Bendix Carstensen, Sigrun Halvorsen, Gisle Langslet, Soulmaz Fazeli Farsani*, Elisabetta Patorno, Júlio Núñez

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

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.
Original languageEnglish
Article number101418
Number of pages17
JournalDiabetes & Metabolism
Volume49
Issue number2
Early online date3 Jan 2023
DOIs
Publication statusPublished - Mar 2023

Keywords

  • All-cause mortality
  • Cardiovascular diseases
  • Comparative effectiveness
  • Dipeptidyl peptidase-4 inhibitors
  • Heart failure
  • Empagliflozin
  • Meta-analysis
  • Observational study
  • Pharmacoepidemiology
  • Sodium-glucose transporter 2 inhibitors

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