Glimepiride and Metformin Fixed-Dose Combination (FDC) along with Metformin + Dapagliflozin + Sitagliptin FDC in T2DM Patients with High Risk for Cardiovascular Disease: GRACE-CVD Study

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Abstract Background: Cardiovascular complications are a major cause of morbidity and mortality in individuals with type 2 diabetes mellitus (T2DM). Fixed-dose combinations (FDCs) of antidiabetic agents may improve glycemic control, cardiovascular outcomes, and treatment adherence. However, real-world evidence in high cardiovascular risk settings is limited. Objective: The GRACE-CVD study evaluated the effectiveness, tolerability, and physician-reported outcomes of dual FDC (Metformin + Glimepiride) and triple FDC (Metformin + Dapagliflozin + Sitagliptin) in T2DM patients with established or high cardiovascular disease (CVD) risk. Materials and Methods: This retrospective, multicenter study analyzed 1772 adult T2DM patients from 150 Indian centers. Patients had either established CVD or high CVD risk. Key parameters, including HbA1c, fasting and postprandial blood glucose, blood pressure, lipid profile, renal function, weight, and adverse events, were assessed over an average follow-up of 4.1 ± 3.1 months. Adherence, satisfaction, and reasons for prescribing FDCs were also captured. Results: Both FDC regimens significantly improved glycemic outcomes, with HbA1c of <7% achieved in 32% of patients at follow-up vs. 8% at baseline ( P < 0.0001). Blood pressure, weight, and renal parameters also improved. Adverse events occurred in 13.2% of patients, with no increase in hypoglycemia. Over 75% showed good adherence, and ~85% of patients and physicians reported satisfaction. Notably, 30% of FDC prescriptions were aimed at improving cardiovascular outcomes. Conclusion: Dual and triple FDCs demonstrated effectiveness and tolerability in improving glycemic and cardiometabolic parameters in T2DM patients with or at high risk of CVD. These findings warrant further prospective studies for long-term cardiovascular impact.

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