Diabetes, Metabolic Syndrome and Obesity (Dec 2022)
Efficacy and Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus Fasting During Ramadan: A Real-World Study from Bangladesh
Abstract
MD Faruque Pathan,1 Nazma Akter,2 Shahjada Selim,3 M Saifuddin,4 Nazmul Kabir Qureshi,5 ABM Kamrul-Hasan,6 Mohammad Abdul Hannan,7 Md Ashraf Uddin Ahmed,1 Marufa Mustari,3 Ashish Kumar Chakraborty1 1BIRDEM General Hospital, Dhaka, Bangladesh; 2MARKS Medical College & Hospital, Dhaka, Bangladesh; 3Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; 4Dhaka Medical College, Dhaka, Bangladesh; 5National Healthcare Network, Dhaka, Bangladesh; 6Mymensingh Medical College & Hospital, Mymensingh, Bangladesh; 7North East Medical College & Hospital, Sylhet, BangladeshCorrespondence: MD Faruque Pathan, BIRDEM General Hospital, 122 Kazi Nazrul Islam Avenue, Dhaka, 1000, Bangladesh, Tel +8801713032888, Email [email protected]: In Bangladesh, there is a large population of Muslims with type 2 diabetes mellitus (T2DM) who fast during Ramadan. Changes in the pattern of meal and fluid intake during this long-fasting hours may increase the risk of hypoglycaemia, hyperglycaemia, and dehydration. Our key point of focus was to evaluate the efficacy and safety of Empagliflozin, a sodium-glucose co transporter 2 inhibitor (SGLT2i), in patients with T2DM while fasting during Ramadan.Methods: This was a 24-weeks, multi-centre, open-label, two-arm parallel-group study. In this prospective type of observational study, we enrolled patients taking Empagliflozin and Metformin with or without a DPP-4 inhibitor in one group (n = 274) and a parallel group (n = 219) who were treated with Metformin with or without a DPP-4 inhibitor. The primary endpoint of this study was HbA1c reduction, weight loss and the number of reported or symptomatic hypoglycemic events. In secondary endpoints, we evaluated the changes from baseline in blood pressure, estimated glomerular filtration rate (eGFR), serum creatinine, and serum electrolyte, the proportion of volume depletion (≥ 1 event) and incidence of other adverse events (AEs) of interest potentially related to SGLT2 inhibitor.Results: During Ramadan, HbA1c reduction was significant in Empagliflozin arm (− 0.49% vs − 0.12%); [p < 0.001]. From before to the end of the study, significant weight reduction was seen in the Empagliflozin arm (− 1.4 kg vs − 0.09 kg); [p < 0.001]. We observed no significant increase in the incidence of hypoglycemia (0.7% vs 0.4%, p = 0.267) and volume depletion (2.6% vs 1.8%; p = 0.55) in both arm. All these milder forms events did not require any hospital admission. There was no report of serious adverse events or any discontinuation, or reduction of prescribed doses of empagliflozin during Ramadan.Conclusion: Empagliflozin is efficacious and safe for treating adults with T2DM during Ramadan.Keywords: empagliflozin, Ramadan, efficacy, safety, T2DM, SGLT2i, SGLT2 inhibitors
