Abstract 60: Safety profile of sodium -glucose co-transporter 2 inhibitors in an Indian cohort of patients with Type 2 diabetes mellitus

Background: The use of Sodium-Glucose Co-transporter 2 inhibitors (SGLT2i's) has been robust from the time cardio-vascular outcome (CVOT) trials have established non-glycemic benefits of this class of medications. They are generally well tolerated with infrequent serious adverse events. The most frequent side effect is genital mycotic infections, others being urinary tract infection, postural hypotension and fatigue, constipation, angioedema and rarely increased amputation risk. We have comparatively fewer studies related to the safety profile of this class of drugs in Indian population. So, in this study we attempt to assess the safety profile of the SGLT2i's in the diabetic cohort at our tertiary care center. Methodology: This study was conducted at Care hospital, outpatient department. It was designed as a prospective observational study conducted over a duration of 3 months. Patients, aged 18 years and above with the diagnosis of type-2 diabetes were included in the study. Patientswere initiated on SGLT2i's as an addition to the existing treatment or de-novo as combination therapy. Each patient was followed up for 3 months and ADRs (adverse drug reactions) reported were recorded. The ADRs were addressed by either treatment or withdrawal of the drug. Results: A total of 751 patients were enrolled as per the calculated sample size. Around 90% (678) patients were initiated on tablet Dapagliflozin, 8% (61) on Empagliflozin, 1-2% each on Canagliflozin (4) and Remogliflozin (8). In the Dapagliflozin group, we observed genital mycosis in only 2% (14/678) patients, UTI in 2.5% (17/678) and frequent urination in 4.5% (31/678) patients. Events of other side effects like back pain, joint pains or nausea was also less common and that of ketoacidosis was nil. Similarly low incidence of side effects was seen with the other drugs. Discussion: Most of the studies done in the western population quoted the incidence of genital mycosis ranging from 2-14%. In this study we noted a very less incidence of genital mycosis and other expected side effects of SGLT2i's, most of which could be mitigated by proper counselling and treatment of the adverse effects. This suggests a better tolerability in Indian population and reassures the safety of this class of drugs.