A REAL WORLD SAFETY STUDY ON DAPAGLIFOZIN, A PRELIMINARY ACTIVE SURVEILLANCE IN A TERTIARY CARE SETTING

Abstract

Background: Dapaglifozin, a popular SGLT 2 inhibitor is frequently used as a single or add on therapy in type 2 diabetes mellitus. With its efficacy established through extensive clinical trials, our study aims to collect preliminary safety data on dapaglifozin through active surveillance.

Material and Methods: The safety profile of dapaglifozin was evaluated in 100 patients aged > 18 years either on mono or add on dapaglifozin treatment  for a duration of > 2 weeks. The safety data was collected  on CRF after obtaining consent for a duration of 4 months from April 2022- July 2022 at a tertiary care hospital. The primary outcome was the proportion and frequency of AEs, causality and severity assessment of AEs. Secondary outcome delineated the association between sociodemographic and dapaglifozin characteristics  with safety data.

Result: On analysis of safety data of 100 patients, mean age was 57.65 + 12.23 years with male preponderance (57%)  with average BMI – 27.75 + 2.42. About 39% adverse events were reported, of which the most common AEs were increased fatiguability (28.2%)(unexpected), hypoglycemia (17.9%), dapa specific adverse events such as genital tract infections (12.8%) and UTI (12.8%), gastro intestinal adverse events (~10-17%) and backpain- 9.09%. With 93% on add on therapy, higher  dose(10mg) and  duration of  administration (218.7 days) were significantly associated with adverse events.

Conclusion: Widespread clinical application of dapaglifozin among diabetics/nondiabetics have been associated with the need for vigilance on the safety data. The real life dapaglifozin safety data collected here contribute to the global incidence and watchlist.