Background: The aim of the study was to evaluate effectiveness and safety of remogliflozin etabonate in a real-world outpatient setting in type 2 diabetes mellitus (T2DM) patients in India.Methods: A retrospective, observational, single-center study wherein medical records of adult patients (≥18 years old) with T2DM managed with remogliflozin 100 mg for at least three months at the diabetes care center in Jharkhand were retrieved. The effectiveness was assessed in terms of change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), total body weight, blood pressure (BP, systolic and diastolic), kidney function tests, and lipid parameters after three months of treatment. Safety was assessed by adverse events (AEs) and serious AEs.Results: Half of the patients received ≥3 concomitant antidiabetic drugs, common being sulphonylureas (92%), and metformin (91%). Remogliflozin treatment resulted in a significant mean reduction from baseline in HbA1c [-1.99 (0.12%); p<0.001], FPG [-52.3 (4.31) mg/dl; p<0.001] and PPG [-103.6 (7.10) mg/dl; p<0.001). Bodyweight reduction was not statistically significant [-0.1 (10.12) kg]. A significant reduction was observed in the systolic BP [-15.9 (2.21) mmHg; p<0.001] and diastolic BP [-3.3 (0.95) mmHg; p=0.001]. Commonly reported AE was heartburn (51.4%) and urinary tract infections (34.2%). No serious AEs were reported. The mean estimated glomerular filtration rate showed a statistically significant reduction of -1.55 (0.61) ml/min. The lipid parameter findings were non-significant.Conclusions: The real-world experience of remogliflozin administered concomitantly with other antidiabetic drugs was effective and well-tolerated in Indian patients with T2DM.
A real-world clinical experience on the effectiveness of remogliflozin etabonate in management of Indian patients with type II diabetes mellitus
