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 -