Comparison of Efficacy and Safety Profile of Sodium-Glucose Cotransporter-2 Inhibitors as Add-On Therapy in Patients With Type 2 Diabetes.

Abstract

BackgroundType 2 diabetes is a chronic metabolic disorder that is escalating at an alarming rate worldwide. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are recent oral antihyperglycemic drugs (OADs) with a unique mechanism of action.ObjectivesThis study aimed compared the efficacy and safety profiles of two SGLT-2 inhibitors, empagliflozin and dapagliflozin, in patients with type 2 diabetes as add-on therapy to traditional first-line OADs.MethodsWe conducted a randomized controlled trial comparing empagliflozin and dapagliflozin in patients with type 2 diabetes. Patients were included in the study if they had type 2 diabetes with inadequate glycemic control, defined as glycated hemoglobin (HbA1c) of 7.5% to 11.0%, treated with conventional first-line OADs. Study participants were randomly assigned into two groups. Group A patients received oral empagliflozin, 10 to 25 mg, and Group B patients received oral dapagliflozin, 5 to 10 mg, for 12 weeks. The primary endpoint was the efficacy profile for each SGLT-2 agent in terms of body weight changes, body mass index (BMI), fasting blood glucose (FBG), and HbA1c. The secondary endpoint was to determine the safety and tolerability profiles of each SGLT-2 agent.ResultsAfter 12 weeks of treatment, the mean body weight was reduced significantly in both groups from baseline (empagliflozin: -3.2 kg ± 5.5 kg, p = 0.003; dapagliflozin -2.1 kg ± 4.6 kg, p = 0.008). However, the mean body weight reduction between groups was not statistically significant (p = 0.078). BMI was significantly reduced in both groups (empagliflozin from 28.5 ± 4.9 kg/m2 to 25.8 ± 5.2 kg/m2, p = 0.002; dapagliflozin from 29 ± 5.2 kg/m2 to 27.7 ± 4.8 kg/m2, p = 0.003). However, the patients who received empagliflozin experienced a significantly greater reduction in BMI than patients who received dapagliflozin (p = 0.007).The mean FBG was also reduced in both study groups (empagliflozin: -88.5 mg/dL ± 39.7 mg/dl, p = 0.003; dapagliflozin: -59.8 mg/dL ± 48.5 mg/dL; p = 0.007). However, the patients who received empagliflozin experienced a significantly greater reduction in mean FBG than patients who received dapagliflozin (p = 0.001). HbA1c was also significantly reduced in both groups (empagliflozin: -2.1% ± 1.1%, p = 0.002; dapagliflozin: -1.4% ± 0.9%; p = 0.004). However, patients who received empagliflozin experienced a significantly greater reduction in HbA1c than patients who received dapagliflozin (p = 0.001).The tolerability profiles of both SGLT-2 agents were quite good, and no major adverse effects were reported in the study groups. Urinary infection occurred more often in patients who received dapagliflozin (9.3%) than in patients who received empagliflozin (4.5%; p = 0.002). Patients in the dapagliflozin group also had a higher incidence of genital infections (7.3%) than those in the empagliflozin group (3.8%; p = 0.001).ConclusionBoth empagliflozin and dapagliflozin demonstrated excellent efficacy and safety profiles in our study. These agents should be considered as add-on therapy in patients with type 2 diabetes taking conventional first-line OADs.