Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) during the month of Ramadan in patients with Type 2 Diabetes Mellitus in Pakistani population -an observational study from a tertiary care center in Karachi

Abstract Background and aims Primary aim was to assess the safety of SGLT2-i in a real-life scenario during Ramadan by finding the frequency and severity of hypoglycemic/hyperglycemic events, dehydration, and DKA. Secondary aim was to assess changes in glycated hemoglobin (HbA1c), weight and creatinine levels. Methods This prospective, observational, controlled cohort study was conducted at Aga Khan University Hospital, Karachi, Pakistan from March 15 to June 30, 2021. Participants were over 21 years of age, on stable doses of SGLT2-I, started at least two months before Ramadan. Endpoint assessments were done one month before and within six weeks after Ramadan. Results Of 102 participants enrolled, 82 completed the study. Most (52%) were males, with mean age 52.2 ± 9.5 years and average duration of T2DM 11.2 ± 6.5 years. 63% were on Empagliflozin (mean dose; 14.8 ± 7.2 mg/day) whereas 37% were on Dapagliflozin (mean dose; 8.2 ± 2.7 mg/day). Six (7.3%) documented symptoms of hypoglycemia, however, no episode of severe hypoglycemia, hyperglycemia, dehydration, DKA, hospitalization or discontinuation of SGLT2i was reported. HbA1c changes were (7.7% ± 1.2% from 7.9% ± 2.3%, p 0.34), weight (78.4 ± 12.9 kgs from 78.9 ± 13.3, p 0.23) and eGFR (87.8 ± 27.9 from 94.3 ± 37.6, p < 0.001). Conclusion Results showed the safety of SGLT2i agents during Ramadan in Pakistani population recommending it as a treatment option in adults with T2DM, without any additional adverse events.