2217-PUB: Remogliflozin in Indian T2DM Patients: A Real-World Study

Abstract

Introduction: Remogliflozin is new SGLT2i approved in India. It is prudent to evaluate its effectiveness and tolerability in real world setting. Methods: In this observational study, retrospective data from EMR of tertiary care hospital in Kolkata, India was retrieved. The records of patients who were uncontrolled (HbA1c>7.5) on dual therapy (Metformin + DPP-4 inhibitors/Sulphonylureas) and subsequently treated with Remogliflozin for period of at least 6 months were selected. The records with evidence of active UTI at baseline, receiving injectable antidiabetic drugs or recorded eGFR <45 mL/min were excluded. The effectiveness was assessed in terms of change in HbA1c, FBS, PPBS, body weight after 3 and 6 months of treatment. The safety was assessed by adverse events recorded in medical records in terms of abnormal symptoms, signs or laboratory reported values. The data was analysed using appropriate statistical techniques. Results: Medical records of 120 adult patients (56.7% male) with T2DM was selected. The mean baseline characteristics of the patients in terms of Age, HbA1c levels, FBS, PPBS, weight and BMI was 58±13 years, 8.2±0.6%, 132.8±12.4 mg/dL, 204±28.2 mg/dL, 71.8±5.4 kg and 28.2±2.6 kg/m2 respectively At end of 6 months of add on Remogliflozin treatment , the mean change from baseline in HbA1c, FBS, PPBS, Body weight and BMI was -1.3±0.4%, -17.2±9.2 mg/dL, -56.4±18.4 mg/dL, -4.2±1.8 kg, -1.8±0.6 kg/m2 (P<0.05 for all parameters). The reduction in body weight was more in patients on SUs as compared to DPP-4 inhibitors (-5.2 vs. -2.9kg). At end of 6 months, HbA1c reduced <8% in all patients while 66% achieved target HbA1c of 7%. No events of hypoglycaemia or electrolyte disturbances were reported. Combined incidence of UTI and GTI was 5.8% which were mild. In none of the patients Remogliflozin was discontinued for adverse events. Conclusion: In real world clinical practice, add on therapy of Remogliflozin to existing OHA regimen is observed to be an effective, safe and tolerable option in management of Indian patients with type 2 diabetes mellitus. Disclosure S. Bhattacharya: None. S. Katare: Employee; Self; Glenmark Pharmaceuticals Limited.