Abstract

AN ENDOCRINOLOGICAL PHARMACOVIGILANCE STUDY ON THE SAFETY ASSESSMENT OF METFORMIN MONOTHERAPY AND THE COMBINATION THERAPY OF REMOGLIFLOZIN WITH METFORMIN, IN THE NEW TYPE II DIABETES MELLITUS PATIENTS, IN TERTIARY CARE MEDICAL COLLEGE HOSPITALS

*Dr. Moumita Hazra

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Abstract

Introduction: Diabetes mellitus type II is globally very common, yet neglected. Remogliflozin, a selective insulin independent sodium glucose co-transporter subtype 2 (SGLT2) inhibitor, inhibits reabsorption of renal glucose, lowers blood sugar, and causes glucosuria, in type II diabetes mellitus patients. Metformin, has similar improved outcomes, as a combination anti-diabetic drug, lowering serum glucose levels, by the activation of 5’ adenosine monophosphate (AMP) activated protein kinase. Objective: An endocrinological pharmacovigilance study on the safety assessment of metformin monotherapy and the combination therapy of remogliflozin with metformin, in the new type II diabetes mellitus patients, in tertiary care medical college hospitals. Methods: 150 new early moderate grade type II diabetes mellitus patients were prescribed oral metformin 500 mg once daily for 30 days. Then, diabetics uncontrolled with metformin, were prescribed oral 50 mg remogliflozin with 500 mg metformin once daily, for 15 days. The safety assessment, along with blood sugar and HbA1c levels and urine routine examination, on day 0, day 30, and day 46, were recorded and statistically analysed. Results: The adverse effects with metformin monotherapy and the combination therapy of remogliflozin with metformin were statistically non-significant; hence both were safe and tolerable. Conclusions: The monotherapy of metformin and the combination therapy of remogliflozin and metformin were safe and tolerable.

Keywords: Remogliflozin, Sodium glucose co-transporter subtype 2 inhibitors, Metformin, Biguanides, Diabetes mellitus type II.