Abstract

A STUDY ON SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN TYPE 2 DIABETES MELLITUS PATIENTS: A RETROSPECTIVE STUDY

Malavika Surendran Nair, *Riya Rose Mathew, Farzeena Basheer, Meppil Baby, Dr. Aksa Simon

ABSTRACT

Background: The efficacy of Dapagliflozin on reduction of Glycated Hemoglobin, Body Mass Index and Blood Pressure in combination with other Oral Hypoglycemic Agent’s has been less extensively studied in the real life context, limiting the comparability of observational real world evidence with results from Dapagliflozin clinical trials. Objective • To assess the effectiveness of Dapagliflozin as Add-on therapy in Type2 Diabetes Mellitus. • To evaluate the safety of Dapagliflozin based on Drug induced Adverse Drug Reactions. Materials and Methods: A retrospective cohort study was conducted over a period of 6 monthsin a tertiary care hospital with a total of 140 patients(70 exposed to Dapagliflozin and 70 non-exposed to Dapagliflozin). Results: The mean baseline HbA1c at 0th month of the treatment was 9.57 ± 1.63% in exposed group. The most common comorbidity was Hypertension (n=47, 67.14%) in both groups. HbA1C levels were ≤7% in 28.6% of the exposed group after 6 months(p<0.001). Systolic Blood Pressure reached ≤140 mmHg in 91.4% from 72.9% in exposed patients(p<0.01).There were significant changes in FBS and BMI in exposed group compared to non exposed group(p<0.001). Dapagliflozin was found to be safe except for the increased incidence of UTI(10%,p<0.001). Conclusion: Dapagliflozin significantly improvedglycemic control, Blood Pressure, BMI and hypoglycemic episodes with a significant percentage of UTIs which is comparable to that of other observational studies. But none of the ADR’s caused the patients to discontinue therapy. Dapagliflozin can be considered as a safe and effective add on therapy in Type 2 Diabetes Mellitus patients with adequatemonitoring.

Keywords: Dapagliflozin, HbA1C, FBS, BMI.