Background:  Sodium–glucose co-transporter (SGLT) 2 inhibitors are the newest oral hypoglycemic agents in the market.  With proven efficacy, they have found their place in clinical therapy as per the ADA/EASD guidelines. Whilst some data demonstrates a clear cardiovascular benefit, other observations have raised the concern of potentially fatal euglycemic DKA. To date there has been no study assessing their clinical efficacy and side effect profile in patients of Indian origin.  

Aim: To retrospectively analyze the side-effect profile of SGLT2 inhibitors in patients diagnosed with type 2 diabetes mellitus. 

Methods:  We retrospectively analyzed the data of 100 patients with type 2 diabetes mellitus (T2DM), who were put on a SGLT2 inhibitor (canagliflozin 100mg/empagliflozin 10mg/dapagliflozin 10mg once daily) , in addition to their ongoing glucose lowering therapy.  The side effect profile/adverse event rate was assessed via a questionnaire.  

Results:  The mean age was 52.41 years, 33% were females and 67% males.  Average body mass index was 23.91±13.89 kg/m2. Baseline weight was 85.85±18.71 kg and HbA1c was 7.1±3.96%.  At 6 months, average weight dropped to 79.77±22.87 kg and HbA1c to 56±3.15. In the overall cohort, 13 patients reported a developing UTI after 1 month of therapy or taking antibiotics as prescribed by General Practitioner and 7 patients after 3 months. By the end of 6 months 23 patients had stopped the drug, at different time points. Of this, 69.5% felt that they should stop due to no defined reason, without consultation of a physician.  21.7% stopped due to a urinary tract infection (UTI).  1 patient reported balanitis and 1 reported vaginitis.  No cases of euglycemic DKA and hypoglycemia were seen.

Conclusion: SGLT2 is a new class of drugs in India. We had large drop-outs of SGLT2, which could be primarily due to perceived UTI and medicine cost. The cases of UTI/GTI in patients were higher than as reported in clinical trials, this drug should be used cautiously in such patients.

Side-effect profile of SGLT2 inhibitors in patients with diabetes at a tertiary care center in India