Objectives: Sodium-glucose cotransporter 2 inhibitors (SGLT2-I) are a new class of antidiabetic drugs that might increase the risk of dehydration and hypoglycemia, particularly during the month of Ramadan in which Muslims abstain from eating and drinking for 14-16 hours daily. We aimed to provide real-life evidence about the safety of SGLT2-I during Ramadan.
Methods: All patients over the age of 18 years on SGLT2-I before Ramadan 2016 who would be fasting during Ramadan were included. Demographic data, detailed medical history including comorbidities and medication profile, and laboratory results were collected before and after Ramadan. We also conducted a phone interview to evaluate the frequency and severity of hypoglycemia and dehydration.
Results: Of the total of 417 patients, 113 (27.0%) experienced hypoglycemic events, and 93 of these (82.3%) checked their blood glucose using a glucometer. Confirmed hypoglycemia (< 70 mg/dL) was observed in 78 (83.8%). The hypoglycemic events were significantly more frequent in the SGLT2-I plus insulin-treated group than in those treated with SGLT2-I plus oral hypoglycemic agents group (p < 0.001). Confirmed hypoglycemic events were more frequent in those using SGLT2-I plus intensive insulin compared to those using SGLT2-I plus basal insulin (p = 0.020). Symptoms of dehydration were seen in 9.3% (n = 39) of the total population. We observed statistically significant reductions in glycated hemoglobin and weight by the end of Ramadan (p < 0.001). There were no significant changes in lipid profile and creatinine levels by the end of the study.
Conclusions: The use of insulin in combination with SGLT2-I increases the risk of hypoglycemia during Ramadan. Hypoglycemic events were mild and did not require hospital admission. However, careful monitoring during prolonged fasting is warranted. No significant harmful effects on renal function result from treatment with SGLT2-I during Ramadan.
Keywords: Diabetes Mellitus, Type 2; Fasting; SGLT2; Safety.