Improvement of Cardiometabolic Control with Dapagliflozin in Patients with Type 2 Diabetes in Primary Care: The AGORA-AP Study

Abstract

Background and Objectives: To assess the effects of adding dapagliflozin to an antidiabetic regimen, compared to standard of care (SOC) antidiabetic therapy and a cohort of patients who remained on a non-SGLT2i antidiabetic regimen without treatment modification despite persistent HbA1c elevation, on cardiometabolic control over a 12-month period in real-world settings. Materials and Methods: This ambispective (retrospective and prospective) observational study enrolled adults with type 2 diabetes who had received first-line metformin therapy, or an alternative antidiabetic agent in cases of intolerance or contraindication, excluding SGLT2 inhibitors, for a minimum of 12 months prior to recruitment. Patients were allocated to one of three groups: DAPA, SOC, or therapeutic inertia. Each patient attended three visits. The retrospective (V1–V0) and prospective (V0–V2) follow-up periods each extended for a minimum duration of six months. The primary endpoint was the change in cardiometabolic control from baseline to week 26 (V0), defined as HbA1c reduction ≥ 0.5%, weight loss ≥ 2 kg, and a systolic blood pressure drop ≥ 2 mmHg. Results: Five hundred thirty-five diabetes patients were included (39.1% women), with mean age (SD) 63.8 (8.2) years, body mass index 30.4 (4.9) kg/m2, and HbA1c 6.93 (0.9) %. More patients achieved cardiometabolic control with dapagliflozin (21.8%) vs. SOC + inertia (1.9%), OR 12.7 (95% CI 5.3–30.6), p < 0.001. The difference became greater over the entire study period. Event rates were low, but dapagliflozin exhibited fewer events numerically. The safety profile of dapagliflozin was consistent with previous findings. Conclusions: Treatment with dapagliflozin as add-on therapy was associated with improved cardiometabolic control over time compared to SOC, along with a numerical reduction in events.