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

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 end-points 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 empagli-flozin 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 infarc-tion, 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.(c) 2023 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)Peer reviewe

Improved control of blood pressure and albuminuria among patients with type-2 diabetes in Finnish open care

<p>Risk of cardiovascular events within the diabetic population has decreased and survival increased with patients living longer and thus facing the development of end-stage renal disease (ESRD). This calls for good care of patient with diabetes with a focus on hypertension. Patient data were collected from 42 Finnish primary care centres. Each was asked to enrol 10–12 consecutive patients with type-2 diabetes between March 2011 and August 2012. Along with the office blood pressure measurements and laboratory tests, the presence of albuminuria was measured and glomerular filtration rate estimated (eGFR). The 2013 ESH criteria for diabetic hypertensive patients (<140/85 mmHg) was reached by 39% of all 625 study patients and 38% of the pharmacologically treated 520 patients. The absence of detectable albumin in urine was significantly associated with the control of systolic blood pressure and achievement of treatment goals. Beta blockers were the most common antihypertensive agents and patients treated with them had lower eGFR compared to those not treated with these agents. The blood pressure of patients was not in full concordance with the present guideline recommendations. However, satisfactory improvement in blood pressure control, reduction of albuminuria and hence ESRD prevention was achieved.</p

25OHD concentrations in the Finnish population aged 45–74 years.

<p>*adjusted for age, gender, BMI, month of sample collection, physical activity and smoking.</p

Association of 25OHD (nmol/l) with Framingham score.

<p>Mean Framingham risk score means the average risk score in each quintile of the study population. Higher score represents higher risk for CVD. P = 0.47 in men and p = 0.44 in women (adjusted for age, gender, BMI, month of sample collection, physical activity and smoking).</p

Prevalence of vitamin D deficiency (25OHD<50 nmol/l) in different age groups.

<p>P = 0.007 in men and p<0.0001 in women (adjusted for gender, BMI, month of sample collection, physical activity and smoking).</p

Association of 25OHD (nmol/l) with apoB/apoA1 ratio.

<p>Mean apoB/apoA1 ratio means the average ratio in each quintile of the study population. Higher ratio represents higher risk for CVD. P = 0.04 in men and p = 0.0002 in women (adjusted for age, gender, BMI, month of sample collection, physical activity, smoking and waist circumference).</p

Prevalence of vitamin D deficiency (25OHD<50 nmol/l) in different BMI groups.

<p>P = 0.10 in men and p<0.0001 in women (adjusted for age, gender, month of sample collection, physical activity and smoking).</p

Association of 25OHD level with metabolic syndrome, type 2 diabetes and estimated cardiovascular disease risk (Framingham score) in the Finnish population aged 45–74 years.

<p>*adjusted for age, gender, BMI, month of sample collection, physical activity and smoking.</p><p>**adjusted for age, gender, BMI, month of sample collection, physical activity, smoking and waist circumference.</p