Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study

Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The aim of our study was to describe the glycemic control, changes in body weight, body mass index (BMI), lipid profile, and BPs in patients receiving dapagliflozin with other antidiabetic medication. Methods: The REWARD study was a multicenter, post-authorization, prospective, open-label, noninterventional, real-world, cohort study. We enrolled 511 adult, type 2 diabetes mellitus patients on antidiabetic medications. These patients were started on dapagliflozin and followed up for 1 year to assess changes in their clinical and laboratory outcomes. Results: The mean HbA1c decreased significantly from 8.5 ± 1.6% at baseline to 7.6 ± 1.3% after 12 months (p value <0.001), with an absolute change of 0.9%. Of the study population, 41.6% of patients reached an HbA1c level less than 7% (53 mmol/mol). The systolic pressure improved (mean change = -1.9 mm Hg, p value = 0.003), yet no change in the diastolic pressure was observed. Both body weight and BMI significantly decreased by 0.7 kg and 0.2 kg/m², respectively (p value <0.001). About 84.5% of patients were on antidyslipidemic agents, while 57.4% were on antihypertensives. Approximately 83.6% of adverse events were mild. A total of 90 hypoglycemic episodes were reported; none were severe. Conclusion: In a real-world setting, dapagliflozin in combination with other antidiabetic medications exhibited significant improvement in glycemic control, weight, BMI, and systolic BP. Additionally, it demonstrated a well-tolerated safety profile.