SGLT2i compared to other non-insulin antidiabetics in Primary Care patients with earlier diabetes. Cohort profile and sample characteristics of DIAB-CV-AP study.

AIM: To describe the methodology and baseline characteristics of the sample of the DIAB-CV-AP study which, as a general objective of the cohort, aims to analyse the possible protective effect of iSGLT2 associated with metformin in patients with T2DM.

METHODS

The National Health System's BIFAP Primary Care prescription database was used, which includes information on 20,831,855 patients. A total of 52,739 patients were identified who started a second non-insulin-based antidiabetic (NIAD) combined with metformin. After propensity score matching, 11,746 patients were obtained, 5873 in each group.

RESULTS

The most used molecules as SGLT2i were dapagliflozin (51.3%) and empagliflozin (34.9%). The prevalence of CV risk factors was dyslipidemia (63.8%) and hypertension (62.9%), and CV disease was present in 7.7% of the patients. CKD prevalence was 1.8%. Patients in the SGLT2i group was younger (53.9 [10.3] vs 60.6 [13.1], p<0.001) with had higher body mass index (32.6 [5.6] vs 31.6 [5.9]; p<0.001), HbA1c (p<0.001), better kidney function (p<0.001) and lower albuminuria (p<0.001). No differences were observed in the cholesterol levels (p=0.519).

CONCLUSIONS

The findings of the DIAB-CV-AP study will expand our knowledge of SGLT2 inhibitors in the early stages of type 2 diabetes mellitus. The recruited cohort, with a lower baseline cardiovascular risk profile than other clinical trials and real-life studies, provides a solid basis for future analyses that will assess whether the protective effect at the cardiovascular and renal levels is reproduced in this clinical context.