Abstract

Efficacy and Safety of Dapagliflozin 10 mg as Add-on to Metformin versus Metformin with or without Other Hypoglycemic Agents in Type 2 Diabetes Mellitus Patients, Retrospective Observational Study

Objective: To assess 10 mg dapagliflozin effectiveness and safety in a real-world setting as add-on therapy and compare it with metformin with or without other hypoglycemic agents (HGA) in type 2 diabetes mellitus (T2DM) patients. Methods: Retrospective chart review observational study at King Khalid University Hospital (KKUH) in Riyadh, Saudi Arabia. Patients were divided into two groups. Dapagliflozin group who had a prescription of dapagliflozin added to metformin (Met) ± 1 or more HGA. The control group was patients using Met ± 1 or more HGA and who didn’t have any sodium glucose co-transporter 2 inhibitor (SGLT2i) prescription. The primary outcome is the change of HbA1c during follow-up period from baseline. Results: 114 patients had at least one prescription for dapagliflozin. For control group 78 patients were included. The decrease in the mean change of HbA1c for dapagliflozin group was significantly higher compared to control group between baseline and during 12-months follow-up period (-1.22% vs. -0.12%; p<0.001), respectively. The change in body weight and body mass index (BMI) were significantly decreased during follow-up from baseline with dapagliflozin group, while increased with control group (-1.74 kg, vs. +0.27 kg; p<0.001) and (-0.70 kg/m2, vs. 0.10 kg/m2; p<0.001), respectively. There was significant difference in urinary tract infection (UTI) with dapagliflozin group [10 (12.8%)], compared to control group [2 (2.6%)] (p=0.032). Conclusion: Dapagliflozin showed extra HbA1c reduction when added to metformin with or without a broad range of HGA in comparison to other HGA in patients with T2DM. 

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