Efficacy and Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus Fasting During Ramadan: A Real-World Study from Bangladesh

Abstract

Aim 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.

Empagliflozin Use among Patients with Heart Failure in the Outpatient Department of Medicine in a Tertiary Care Centre

“…However, no significant increase in the incidence of hypoglycemia and volume depletion has been noted in a study done in Bangladesh. 11 We did not find any patients with hypoglycemia but hypotension and AKI were present in 6-7% of patients which could be due to concomitant use of other drugs like diuretics.…”

Ramadan Fasting and Diabetes (2022): The Year in Review

“…The second investigated the efficacy and safety of empagliflozin in patients with T2DM while fasting during Ramadan in a 24 weeks, multicenter, open-label, two-arm parallel-group study. 19 HbA1c reduction was significant in the empagliflozin arm (−0.49% vs. −0.12%); [ p < 0.001]). Significant weight reduction was seen in the Empagliflozin arm (1.4 vs. 0.09 kg; p < 0.001).…”

“…Several research studies on the subject were published in 2022. [15][16][17][18][19][20] In one study, the efficacy and safety of empagliflozin in people with T2DM during RF were determined. 15 People with T2DM who took empagliflozin and sulfonylurea with or without metformin and dipeptidyl peptidase inhibitors (DPP-4) were recruited a month before Ramadan.…”

Safety and tolerability of Empagliflozin use during the holy month of Ramadan by fasting patients with type 2 diabetes: A prospective cohort study

“…Several experts in diabetes have reevaluated the current recommendations for the use of SGLT2i during Ramadan fasting based on studies focused on Canagliflozin and Dapagliflozin; however, few studies have examined the use of Empagliflozin in this context. ( Ahmed et al, 2022 , Bashier et al, 2018 , Goh et al, 2023 , Hassanein et al, 2022 , Hassanein et al, 2017 , Pathan et al, 2022 , Shao et al, 2018 ).…”

“…Only one study discussed Empagliflozin use in Ramadan by fasting Muslims and was conducted in Bangladesh however the study excluded patients on insulin secretagogues which is commonly prescribed with SGLT2i. ( Pathan et al, 2022 ) Therefore, this study aimed to assess the safety and tolerability of Empagliflozin along with other oral hypoglycemic agents in patients with type 2 diabetes mellitus among Muslim patients who fast during Ramadan.…”