AN EVIDENCE-BASED DIABETOLOGICAL RESEARCH STUDY ON THE PHARMACOTHERAPEUTIC PRESCRIPTION PATTERNS AND ADVERSE DRUG REACTIONS MONITORING OF 50 mg OR 75 mg REMOGLIFLOZIN WITH 500 mg METFORMIN COMBINATION TREATMENT, IN GLOBAL TERTIARY CARE HOSPITALS.

Dr. Moumita Hazra

ABSTRACT

Introduction: 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, as a combination anti-diabetic drug, lowers serum glucose levels, by the activation of 5’ adenosine monophosphate (AMP) activated protein kinase. Objectives: The objective of this evidence-based diabetological research study was the pharmacotherapeutic prescription patterns and adverse drug reactions monitoring of 50 mg or 75 mg remogliflozin with 500 mg metformin combination treatment, in global tertiary care hospitals. Methods: 250 new early moderate grade type II diabetes mellitus patients were prescribed oral metformin 500 mg once daily for 30 days. Then, 200 diabetics uncontrolled with metformin monotherapy, were prescribed oral 50 mg remogliflozin with 500 mg metformin once daily, for 15 days; who were subsequently prescribed oral 75 mg remogliflozin with 500 mg metformin once daily for 15 days. The prescription patterns, glycaemic stabilisation rate and the prescription rates of anti-diabetic percentage glycaemic stabilisation of both the anti-diabetic monotherapy and combination therapies provided, were analysed. The percentage of prescriptions of metformin combination therapies, with which glycaemic stabilisation was achieved, as well as the percentage of prescriptions of metformin combination therapies, with which glycaemic stabilisation was not adequately achieved, was calculated. The prescription content analysis, of all the 250 prescriptions, was done. The safety assessment, along with blood sugar and HbA1c levels and urine routine examination, on day 0, day 30, day 46, day 60, and further follow-up, were recorded and statistically analysed. Results: Well-controlled glycaemic stabilisation was observed with metformin combination therapies in 198 prescriptions, that is, among 99% patients, whereas glycaemic stabilisation was not adequately controlled with 2 prescriptions, that is, among 1% patients, after 1 month of combination therapies. Prescription content analyses showed 100% completeness, with significant pharmacotherapeutic molecular efficacy. The adverse effects with the combination therapy of 50 mg remogliflozin with metformin and the combination therapy of 75 mg remogliflozin with metformin were statistically non-significant; hence both were safe and tolerable. Conclusions: The prescription rates of anti-diabetic percentage glycaemic stabilisation were as follows: prescription percentage of well-controlled glycaemic stabilisation with metformin combination therapies > prescription percentage of inadequate glycaemic stabilisation with metformin combination therapies. The prescription content analyses showed 100% completeness. The combination therapy of 50 mg remogliflozin and metformin as well as the combination therapy of 75 mg remogliflozin and metformin were safe and tolerable.

Keywords: Biguanides, Metformin, Sodium Glucose Co-Transporter Subtype 2 Inhibitors, Remogliflozin, Prescription Patterns, Prescription Content Analysis, Pharmacovigilance, Diabetology.