Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Korean Patients with Type 2 Diabetes Mellitus in Real-World Clinical Practice

Abstract

BackgroundThis study aimed to evaluate the efficacy and safety of sodium-glucose cotransporter-2 (SGLT2) inhibitors in Korean patients who had inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.MethodsWe included 410 patients who started SGLT2 inhibitors (empagliflozin or dapagliflozin) as add-on therapy or switch therapy between February 2015 and June 2017. The primary efficacy endpoint was a change in glycosylated hemoglobin (HbA1c) from baseline to week 12. The secondary endpoints were patients achieving HbA1c <7.0% and changes in the fasting plasma glucose (FPG), lipid profiles, body weight, and blood pressure (BP).ResultsThe mean HbA1c at baseline was 8.5% (8.6% in the add-on group and 8.4% in the switch group). At week 12, the mean adjusted HbA1c decreased by −0.68% in the overall patients (P<0.001), by −0.94% in the add-on group, and by −0.42% in the switch group. Significant reductions in FPG were also observed both in the add-on group and switch group (−30.3 and −19.8 mg/dL, respectively). Serum triglyceride (−16.5 mg/dL), body weight (−2.1 kg), systolic BP (−4.7 mm Hg), and diastolic BP (−1.3 mm Hg) were significantly improved in the overall patients. Approximately 18.3% of the patients achieved HbA1c <7.0% at week 12. A low incidence of hypoglycemia and genital tract infection was observed (6.3% and 2.2%, respectively).ConclusionSGLT2 inhibitors can be a suitable option as either add-on or switch therapy for Korean patients with inadequately controlled T2DM.

Efficacy and Safety of Luseogliflozin in Patient with Type 2 Diabetes Complicated by Hepatic Dysfunction

“…inhibitors presented with relatively higher HOMA than the group responding poorly to SGLT2 inhibitors. Nevertheless, the HOMA-β level was not associated with SGLT2 inhibitor responsiveness [28]. The results of this study suggested that SGLT2 inhibitors improved insulin resistance but not insulin secretion in the pancreatic β-cells of T2DM patients.…”

Use and effectiveness of dapagliflozin in patients with type 2 diabetes mellitus: a multicenter retrospective study in Taiwan

“…Regarding the effects of dapagliflozin by manners of initiation, we found patients who initiated dapagliflozin as add-on therapy had a significantly greater reduction in HbA1c (−0.82%) than those who were switched (−0.66%) from other OADs. Two recent studies also showed treatment with SGLT2 inhibitors (i.e., dapagliflozin or empagliflozin) as add-on therapy had a greater glucose-lowering effect than as switch therapy (Han et al, 2018;Hong et al, 2019). Notably, we found DPP4 inhibitors accounted for the majority (69.5%) of the switched agents (data not shown), a finding which is likely due to the fact that Taiwan's NHI only covers either a DPP4 inhibitor or an SGLT2 inhibitor.…”

“…In general, studies suggest that patients with higher baseline HbA1c experienced a greater reduction in HbA1c with dapagliflozin treatment (Brown, Gupta & Aronson, 2017;Han et al, 2018;Hong et al, 2019;Scheerer et al, 2016), and one study indicates that a lower baseline HbA1c was associated with the achievement of HbA1c goal (<7%) (Wilding et al, 2017). Other patient characteristics that may be associated with better dapagliflozin response were male (Brown, Gupta & Aronson, 2017), younger age (<45 years old) (Wilding et al, 2017), shorter disease duration (<2-4 years), (Brown, Gupta & Aronson, 2017;Wilding et al, 2017) and non-insulin use (Brown, Gupta & Aronson, 2017;Hong et al, 2019); however, some of these associations were not identified and other data were not available in the current study. On the other hand, baseline body weight or BMI did not influence the magnitude of reduction in HbA1c, which is similar to previous studies (Han et al, 2018;Scheerer et al, 2016;Wilding et al, 2017).…”

A 12 week prospective clinical evidence of empagliflozin efficacy in uncontrolled type 2 diabetes mellitus treated with metformin and a sulfonylurea

“…In the present study, the addition of empagliflozin to metformin and sulfonylurea therapy for 12 weeks provided 0.87% reduction in HbA1c. 23 An investigation on effectiveness of SGLT2 inhibitors have shown a significant reduction in mean weight and HbA1c reduction 3.2 kg and 1.26%, respectively. 24 Based on four months follow-up, a study reported 0.7 % HbA1c reduction, weight dropped for an average −2.0 kg, SBP dropped significantly, but no change in DBP were observed.…”