Qazi Masroor Ali, Ali Imran, Raheel Khan, Maria Masroor, Sohail Tariq, Ghulam Mohy U Din Chaudhary.
Efficacy and Safety of Dapagliflozin in Treatment Naive or Treatment Experienced Type 2 Diabetes Mellitus patients from South Punjab, Pakistan.
J Pak Society Int Med Jan ;2(2):135-9.

Objective: To gather clinical data regarding weight reduction, glycemic control and safety of dapagliflozin oral tablets in Type 2 Diabetes Mellitus patients from South Punjab, Pakistan. Methods: This prospective clinical trial was conducted at Department of Medicine, Bahawal Victoria Hospital, Bahawalpur from July 2019 to June 2020. A total of 400 patients of genders aged above 18 years, BMI > 25 and having type-2 diabetes mellitus were enrolled. Patients losing planned follow ups were excluded from the final analysis. Dapagliflozin as 5mg or 10mg was prescribed. Patients were asked to follow up after every 2 weeks up till 24 weeks. Change in weight, HbA1c, FBS, RBS and blood pressure was recorded during the follow ups. Results: Out of a total of 400 patients enrolled, 238 (59.5%) were female. Overall, mean age was 48.06+10.38 years. Mean baseline body weight was noted to 78.81+-15.67 kg. Mean HbA1c (%) was recorded to be 9.14+2.12. Statistically significantly reduction in body weight was noted at 4 weeks, 12 weeks and 24 weeks when compared to baseline values (p<0.05). Statistically significant reduction in HbA1c levels were recorded among study participants at 12th week (change in HbA1c=0.42+0.75, p=0.0022) and 24th weeks (change in HbA1c=0.85+0.67, p<0.0001). In terms of side effects, hypoglycemia was reported in 12 (3.0%) patients, polyuria 10 (2.5%), urinary tract infection 5 (1.3%) and genital infection 4 (1.0%) patients. Conclusion: Dapagliflozin was found to have good efficacy in terms of body weight reduction and improvement in glycemic control among patients with T2DM. Overall, safety profile of dapagliflozin was good.

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