A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe

Abstract

Introduction: A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings. Methods: We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria. Results: In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p \ 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA 1c was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p \ 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%). Conclusions: Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11316458.

Dapagliflozin is associated with improved glycaemic control and weight reduction at 44 months of follow-up in a secondary care diabetes clinic in the UK

“…A recent study examined the different baseline characteristics of patients who were initiated on dapagliflozin and suggested that this may influence patient outcomes. Whilst we saw differences relating to weight and BMI in different therapy groups, the effect on HbA1c appeared to be consistent [8].…”

“…At baseline, the mean age was 61 ±10 years, HbA1c 82.6 ±15.7 mmol/mol, weight 106 ±21 kg, BMI 37 ±7 kg/m 2 . The sample comprised of 101 patients (43 males, 58 females) with a median duration of diabetes of 12 years (interquartile range [8][9][10][11][12] and a median duration of dapagliflozin treatment of 44 months (range 36-82).…”

“…SGLT-2i have beneficial effects in the clinical trial [1][2][3] and the real-world setting [4][5][6]. There is debate relating to the validity of cardiovascular outcome trials [7] and the real-world trials [8] to routine practice. We describe our real-life clinical experience of dapagliflozin in secondary care with a median treatment duration of 44 months (range 36-82 months).…”

Cardiovascular and mortality benefits of sodium–glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia

“…However, it is important to examine whether these results can be replicated in Southern Europe areas other than Italy, the only countries of this region included and only regarding the assessment of renal outcomes in the CVD REAL available studies [ 19 ]. It is also important to consider that Fadini et al reported that there are country-specific differences in the profile and characteristics of patients initiating dapagliflozin in Southern Europe [ 31 ]. In their real-world practice study, including patients from Italy, Spain, and Greece, the authors found that the SGLT2i dapagliflozin was initiated at different stages depending on the country, with significant differences regarding age, mean T2DM duration, and the presence of comorbidities (e.g., retinopathy, prior stroke, MI, or CVD) [ 31 ].…”

“…It is also important to consider that Fadini et al reported that there are country-specific differences in the profile and characteristics of patients initiating dapagliflozin in Southern Europe [ 31 ]. In their real-world practice study, including patients from Italy, Spain, and Greece, the authors found that the SGLT2i dapagliflozin was initiated at different stages depending on the country, with significant differences regarding age, mean T2DM duration, and the presence of comorbidities (e.g., retinopathy, prior stroke, MI, or CVD) [ 31 ]. The authors concluded that the observed geographic heterogeneity might not only have an impact in the glucose-lowering effectiveness of SGLT2i but also in the protective CV and renal outcomes.…”