Safety and efficacy of Empagliflozin in Pakistani Muslim Patients with Type 2 Diabetes (SAFE-PAK); A Randomized Clinical Trial.

Published: 20 June 2022| Version 1 | DOI: 10.17632/9g3bvkyjzw.1
Contributors:
Aziz Ul Hasan Aamir, Umer Yousuf Raja, Faisal Qureshi, Ali Asghar, Saeed Ahmed Mahar, Ibrar Ahmed, Tahir Ghaffar, Jamal Zafar, Mohammad Imtiaz Hasan, Amna Riaz, Abbas Raza, Irshad Ahmed Khosa, Jahanzeb Khan, Jaffer Bin Baqar

Description

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).

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Categories

Diabetes, Clinical Trial, Drug Safety, Efficacy Assessment

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