Real-world characteristics, modern antidiabetic treatment patterns, and comorbidities of patients with type 2 diabetes in central and Eastern Europe: retrospective cross-sectional and longitudinal evaluations in the CORDIALLY® study

Abstract

Background: Guidelines from 2016 onwards recommend early use of SGLT2i or GLP-1 RA for patients with type 2 diabetes (T2D) and cardiovascular disease (CVD), to reduce CV events and mortality. Many eligible patients are not treated accordingly, although data are lacking for Central and Eastern Europe (CEE).

Methods: The CORDIALLY non-interventional study evaluated the real-world characteristics, modern antidiabetic treatment patterns, and the prevalence of CVD and chronic kidney disease (CKD) in adults with T2D at nonhospital-based practices in CEE. Data were retrospectively collated by medical chart review for patients initiating empagliflozin, another SGLT2i, DPP4i, or GLP-1 RA in autumn 2018. All data were analysed cross-sectionally, except for discontinuations assessed 1 year ± 2 months after initiation.

Results: Patients (N = 4055) were enrolled by diabetologists (56.7%), endocrinologists (40.7%), or cardiologists (2.5%). Empagliflozin (48.5%) was the most prescribed medication among SGLT2i, DPP4i, and GLP-1 RA; > 3 times more patients were prescribed empagliflozin than other SGLT2i (10 times more by cardiologists). Overall, 36.6% of patients had diagnosed CVD. Despite guidelines recommending SGLT2i or GLP-1 RA, 26.8% of patients with CVD received DPP4i. Patients initiating DPP4i were older (mean 66.4 years) than with SGLT2i (62.4 years) or GLP-1 RA (58.3 years). CKD prevalence differed by physician assessment (14.5%) or based on eGFR and UACR (27.9%). Many patients with CKD (≥ 41%) received DPP4i, despite guidelines recommending SGLT2is owing to their renal benefits. 1 year ± 2-months after initiation, 10.0% (7.9-12.3%) of patients had discontinued study medication: 23.7-45.0% due to 'financial burden of co-payment', 0-1.9% due to adverse events (no patients discontinued DPP4i due to adverse events). Treatment guidelines were 'highly relevant' for a greater proportion of cardiologists (79.4%) and endocrinologists (72.9%) than diabetologists (56.9%), and ≤ 20% of physicians consulted other physicians when choosing and discontinuing treatments.

Conclusions: In CORDIALLY, significant proportions of patients with T2D and CVD/CKD who initiated modern antidiabetic medication in CEE in autumn 2018 were not treated with cardioprotective T2D medications. Use of DPP4i instead of SGLT2i or GLP-1 RA may be related to lack of affordable access, the perceived safety of these medications, lack of adherence to the latest treatment guidelines, and lack of collaboration between physicians. Thus, many patients with T2D and comorbidities may develop preventable complications or die prematurely. Trial registration NCT03807440.

Keywords: Cardiovascular disease (CVD); Cardiovascular outcomes trials (CVOTs); Cardiovascular safety; Chronic kidney disease (CKD); Dipeptidyl peptidase-4 inhibitors (DPP4i); Glucagon-like peptide-1 receptor agonists (GLP-1 RA); Glucose-lowering drug; Sodium-glucose cotransporter-2 inhibitors (SGLT2i); Type 2 diabetes.

Fig. 1

Enrolment by HCP specialty (Prescribed Patient Set). HCP, healthcare professional

Fig. 2

T2D study medication prescriptions (Prescribed Patient Set). DPP4i, dipeptidyl peptidase-4 inhibitor; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HCP, healthcare professional; SGLT2i, sodium-glucose cotransporter-2 inhibitor; T2D, type 2 diabetes

Fig. 3

‘Highly relevant’ reasons for choosing T2D study medications A by HCP specialty B by treatment (Prescribed Patient Set). AE, adverse event; CV, cardiovascular; DPP4i, dipeptidyl peptidase-4 inhibitor; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycated haemoglobin; HCP, healthcare professional; SGLT2i, sodium-glucose cotransporter-2 inhibitor; T2D, type 2 diabetes

Fig. 4

Prevalence of A CVD and CKD B types of CVD at baseline (Prescribed Patient Set). *These laboratory values were available for 78.3% (n = 3175) of 4055 patients in the Prescribed Patient Set. Thus, the denominators used to calculate the percentages of patients with CKD according to eGFR and UACR were 3175 (all HCPs), 1493 (endocrinologist group), 1604 (diabetologist group), 78 (cardiologist group). CABG, coronary artery bypass graft; CHF, congestive heart failure; CHF by ECG, CHF confirmed by electrocardiography; CKD, chronic kidney disease. CVD, cardiovascular disease; DPP4i, dipeptidyl peptidase-4 inhibitor; eGFR, estimated glomerular filtration rate; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HCP, healthcare professional; IHD, ischaemic heart disease; MI, myocardial infarction; PAD, peripheral arterial disease; PCI, percutaneous coronary intervention; SGLT2i, sodium-glucose cotransporter-2 inhibitor; UACR, urine albumin-creatinine ratio

Fig. 5

T2D study medication use in patients with and without A CVD and B CKD at baseline (Prescribed Patient Set). CVD, cardiovascular disease; CKD, chronic kidney disease; DPP4i, dipeptidyl peptidase-4 inhibitor; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HCP, healthcare professional; SGLT2i, sodium-glucose cotransporter-2 inhibitor

Fig. 6

A Discontinuations at 1 year ± 2 months of treatment and B primary reasons for discontinuing T2D study medications (Full Analysis Set). AE, adverse event; DPP4i, dipeptidyl peptidase-4 inhibitor; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HCP, healthcare professional; SGLT2i, sodium-glucose cotransporter-2 inhibitor; T2D, type 2 diabetes