Real-world assessment of effectiveness and safety profile of remogliflozin etabonate in management of type 2 diabetes mellitus

Aim To assess the real-world effectiveness and safety of remogliflozin in the management of type 2 diabetes mellitus (T2DM) in a large uncontrolled population. Methods A retrospective cohort analysis was conducted at 1578 sites across India. Medical records of all patients who had received a remogliflozin-based regimen for a 3-month duration as per routine practice for the management of T2DM were analysed for effectiveness and safety. The efficacy assessments included mean change in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), bodyweight, BMI, and blood pressure from baseline to 3 months. Safety assessments included incidence of adverse events reported. Results A total of 5452 eligible patients' data were analysed. The mean change of HbA1c level from baseline (8.63%) to 3-month follow-up (7.68%) was - 0.95%. The mean change in FPG and PPG from baseline to the end of follow-up was - 42.4 mg/dL and - 69.1 mg/dL, respectively. A significant reduction in glycemic parameters was observed from baseline to follow-up. The overall incidence of adverse events (AEs) was about 25.9%. Genito-urinary tract infections (12.6%) were more frequently reported AEs, and no severe AEs were reported. Conclusion Remogliflozin etabonate was effective in improving glycemic parameters. It was well-tolerated in the real-world setting used for glycemic management of T2DM.