TY - JOUR

T1 - Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia

T2 - Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study

AU - Karasik, Avraham

AU - Lanzinger, Stefanie

AU - Chia-Hui Tan, Elise

AU - Yabe, Daisuke

AU - Kim, Dae Jung

AU - Sheu, Wayne H.H.

AU - Melzer-Cohen, Cheli

AU - Holl, Reinhard W.

AU - Ha, Kyoung Hwa

AU - Khunti, Kamlesh

AU - Zaccardi, Francesco

AU - Subramanian, Anuradhaa

AU - Nirantharakumar, Krishnarajah

AU - Nyström, Thomas

AU - Niskanen, Leo

AU - Linnemann Jensen, Majken

AU - Hoti, Fabian

AU - Klement, Riho

AU - Déruaz-Luyet, Anouk

AU - Kyaw, Moe H.

AU - Koeneman, Lisette

AU - Vistisen, Dorte

AU - Carstensen, Bendix

AU - Halvorsen, Sigrun

AU - Langslet, Gisle

AU - Fazeli Farsani, Soulmaz

AU - Patorno, Elisabetta

AU - Núñez, Júlio

AU - EMPRISE Europe and Asia Study Group

N1 - Publisher Copyright: © 2023 The Authors

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - All-cause mortality

KW - Cardiovascular diseases

KW - Comparative effectiveness

KW - Dipeptidyl peptidase-4 inhibitors

KW - Empagliflozin

KW - Heart failure

KW - Meta-analysis

KW - Observational study

KW - Pharmacoepidemiology

KW - Sodium-glucose transporter 2 inhibitors

U2 - 10.1016/j.diabet.2022.101418

DO - 10.1016/j.diabet.2022.101418

M3 - Journal article

C2 - 36608816

AN - SCOPUS:85146274656

VL - 49

JO - Diabetes & Metabolism

JF - Diabetes & Metabolism

SN - 1262-3636

IS - 2

M1 - 101418

ER -