Safety and efficacy of Empagliflozin in Pakistani Muslim Patients with Type 2 Diabetes (SAFE-PAK); A Randomized Clinical Trial.
This study aimed to establish the safety and efficacy of Empagliflozin (Group-A) versus standard care (Group-B) in Pakistani Muslim individuals with type 2 diabetes. Out of 745 screened patients, 333 met the eligibility criteria, and a total of 244 (73.3%) patients were enrolled. Hypoglycemic events were significantly reported more in the standard care group, whereas positive urine culture, fungal infection, dehydration, and hypotension were insignificant between the two groups. The 6 months mean HbA1c reduction was significant in both groups; (Group-A: 0.91 ± 0.15; p<0.001 vs. Group-B2: 0.79 ± 0.14; p<0.001). Efficacy comparison at 6 months revealed a significant reduction in weight and systolic blood pressure (SBP) in Group A only (Group-A: 1.4 ± 0.4 kg; p<0.002 vs. Group-B: 0.01 ± 0.5 kg; p<1.00), (Group-A: 5.1 ± 1.7 mmHg; p<0.012 vs. Group-B: 2.3 ±1.7 mmHg; p<0.526).