Efficacy and safety of empagliflozin (SGLT2 inhibitor) in Bangladeshi patients with type 2 diabetes mellitus
Abstract
Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder requiring effective glycemic control to prevent complications.
Methods: This 8-month, randomized, open-label, interventional, single centered trial enrolled 86 Bangladeshi patients with poorly controlled T2DM (HbA1c ≥7.5%) on various antidiabetic regimens. Participants received Empagliflozin 10mg/25mg in addition to their ongoing therapy. Follow-ups at 6 weeks and 6 months evaluated glycemic control, lipid profile, renal parameters and adverse effects. Based on clinical response, the dosage was increased to 25 mg in selected cases. Statistical analyses included paired t-tests and Wilcoxon Signed Rank tests for normally and non-normally distributed variables.
Results: Hypertension was prevalent in 73.3% of cases, while chronic kidney disease (CKD), ischemic heart disease and dyslipidemia were observed in 12.8%, 14% and 37.2% of cases, respectively. Significant reductions in fasting blood sugar, postprandial blood sugar, systolic blood pressure (p<0.001 for all) and HbA1c (p<0.001) were observed at both 6-week and 6-month follow-ups. BMI reduction was significant at 6 months (p=0.03), while serum potassium increased significantly at both time points (p=0.02, p=0.01). Serum creatinine showed a significant decline at 6 months, while changes in LDL, triglycerides, HDL and total cholesterol were not statistically significant. Adverse effects were minimal, with 3.5% experiencing genital mycotic infections…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 86 participants or records.
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