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

Abstract

Background: The main aim of the study is to evaluate the efficacy of empagliflozin 10 mg once daily over 12 weeks as add-on therapy to metformin plus sulfonylurea in patients with type 2 diabetes mellitus with inadequate glycemic control.Methods: It is a prospective, observational, study conducted in patients of Sri Badhrakali Diabetic Center located in Warangal, Telangana, India. The efficacy of empagliflozin 10 mg was assessed by measuring the change in the glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), body mass index (BMI) at the baseline and 12 weeks, systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the baseline and after 24 hours of treatment.Results: In the present study, the addition of empagliflozin to metformin and Sulfonylurea therapy for 12 weeks provided 0.87 % reduction in HbA1c. The mean changes of FPG from baseline to 12-week is -26 mg/dl. At 24 hours empagliflozin significantly reduced blood pressure with mean changes of SBP and DBP -4.147 and -1.526 mmHg respectively. The mean changes in BMI from baseline to week 12 is -0.638 kg/m2.Conclusions: Empagliflozin 10 mg provided ancillary reduction in HbA1c outside of metformin and sulfonylurea. Controlled body weight, HbA1c, blood pressure decreases diabetes progression, decreased risk of diabetic complications and reduced risk for cardiovascular disorders.

Efficacy of Empagliflozin as Add-on Therapy in Patients with Uncontrolled Type 2 Diabetes Mellitus

“…Our study found that the mean systolic and diastolic blood pressures decreased from 129 mmHg to below 120 mmHg (p < 0.001) and 82.3 mmHg to below 80 mmHg (p = 0.029), respectively, after three months of intervention. Our findings were in good agreement with Puli and Vanjari & Zhong et al 13,15 Puli and Vanjari, 13 in a prospective study demonstrated that at 24 hours, empagliflozin significantly reduced blood pressure with mean change in SBP and DBP were 4.147 and 1.526 mmHg respectively.…”

“…The overall reduction of FBS from baseline to 12 weeks of intervention is statistically significant (p < 0.001), which was in line with the study of Puli and Vanjari and Søfteland and associates. 13,14 Puli and Vanjari, 13 in a prospective study in India, demonstrated that the mean change of FBS from baseline to 12 weeks was 26 mg/dl. Søfteland and associates 14 evaluated the efficacy and safety of empagliflozin as add-on therapy in inadequately controlled type 2 diabetic patients under treatment of linagliptin and metformin and found that fasting blood sugar (FBS) and weight was significantly reduced in both empagliflozin groups versus placebo (p<0.001 for all comparisons).…”

“…These findings were in accordance with studies done by Puli and Vanjari, Søfteland and associates, Zhong et al, & Kovacs and associates. 13,14,15,16 A prospective study conducted by Puli and Vanjari 13 demonstrated that the addition of empagliflozin to metformin and sulfonylurea therapy for 12 weeks caused a 0.87% reduction in HbA1c. Søfteland and associates 14 evaluated the efficacy and safety of empagliflozin as add-on therapy in inadequately controlled type 2 diabetic patients under treatment of linagliptin and metformin and concluded that at week 24, empagliflozin significantly reduced HbA1c compared to placebo; the adjusted mean differences in the change from baseline with empagliflozin 10 and 25 mg in comparison to placebo were 0.79% and 0.70% respectively (both p < 0.001).…”