Evaluation of Efficacy and Safety of Empagliflozin in Bangladeshi Patients with Type 2 Diabetes Mellitus (EFFISAEM Study)

Abstract Background: Empagliflozin is a relatively newer glucose-lowering drug (GLD) with many extra-glycemic benefits. To date, no study has evaluated the efficacy and safety of empagliflozin in Bangladeshi patients with type 2 diabetes mellitus (T2DM). Objectives: To assess the efficacy and safety of empagliflozin as an add-on to ongoing GLDs in Bangladeshi adults with uncontrolled T2DM. Materials and Methods: This real-world, multicenter, open-label, prospective study was carried out at 21 sites throughout Bangladesh from 1 February 2022 to 31 July 2022. Patients with T2DM who met the criteria had Empagliflozin added to their existing GLD treatment, with necessary modifications to their ongoing medication regimen. The efficacy and safety data were collected 12 weeks after empagliflozin initiation. Results: Out of 1449 subjects initiating empagliflozin, 1340 subjects [age 50.3 ± 9.0 years, male 52.5%, overweight/obese 94.4%, insulin-treated 25.7%, baseline hemoglobin A1c (Hba1c) 9.9 ± 1.4%] completed the study. At 12 weeks, the reduction in HbA1c was 1.6% (95% CI 1.5-1.6, P < 0.001); 12.5% of the study subjects achieved HbA1c < 7%. There were also significant (P < 0.001 in all instances) reductions in fasting plasma glucose (3.0 mmol/L), plasma glucose 2 hours after breakfast (4.8 mmoL/L), body weight (1.9 kg), body mass index (0.8 kg/m2), systolic blood pressure (BP) (10 mmHg), diastolic BP (7 mmHg), insulin dose (3 U), serum creatinine (0.06 mg/dL), total cholesterol (18 mg/dL), low-density lipoprotein cholesterol (13 mg/dL), high-density lipoprotein cholesterol (1 mg/dL), and triglyceride (42 mg/dL) and an increase in estimated glomerular filtration rate (4.2 mL/min/1.73 m2) from the baseline values. 6.62% experienced adverse events (lightheadedness 2.21%, genital tract infection 0.97%, urinary tract infection 1.24%, generalized weakness 0.48%, and nocturia 0.48%). 1.1% of subjects experienced hypoglycemia, and other 0.12% reported severe hypoglycemic events. Conclusion: Empagliflozin is effective, safe, and tolerable for treating Bangladeshi patients with uncontrolled T2DM as add-on therapy in routine clinical practice with favorable effects on body weight, BP, lipid profile, and renal function.