Objectives: To directly compare the effectiveness of HbA1c reduction between two distinct SGLT2 inhibitors, Empagliflozin (EMPA, 25 mg/day) and Dapagliflozin (DAPA, 10 mg/day), as part of a quadruple OAD drug regimen.
Research Design and Methods: This study was an open-labeled, prospective, observational, 52-week study conducted in a clinical practice. T2D patients (HbA1c, 7.5-12.0%) with three different OADs (metformin, glimepiride, and dipeptidyl peptidase-4 inhibitors) were enrolled to either EMPA or DAPA. The outcome measures included changes in HbA1c, fasting plasma glucose (FPG), and cardiometabolic variables at week 52 and the safety outcomes of treatment-emergent adverse events.
Results: In total, 350 patients were enrolled with EMPA (N=176) and DAPA (N=174), respectively. After 52 weeks, both groups showed significant reductions (P <0.001) in HbA1c and FPG, but the reduction was greater in the EMPA group. In addition, both groups showed decreased blood pressure and body weight with improved liver function, and high-density lipoprotein cholesterol levels were significantly increased in the EMPA (1.9 ± 5.7 mg/dl, P <0.001 and 0.6 ± 4.5 mg/dl, P = 0.157, respectively) (between groups, P = 0.035). Both groups were well tolerated with overall similar safety profiles.
Conclusions: Our present study demonstrated that SGLT2 inhibitors can be safely and effectively used as a fourth OAD in T2D patients who are already being treated with three other OADs to control their hyperglycemia. More specifically, Empagliflozin was more effective in reducing HbA1c and improving other cardiometabolic parameters affecting patient health in T2D. Our findings show that 4 different OADs can be used as a viable therapeutic regimen to treat T2D, especially in patients who are unwilling to use injectable therapies as their alternate method to control blood glucose.
E. Ku: None. D. Lee: None. H. Jeon: None. T. Oh: None.