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.

Keywords:

• empagliflozin
• Ramadan
• efficacy
• safety
• T2DM
• SGLT2i
• SGLT2 inhibitors

Contributing Investigators

Dr. Mohaiminul Abedin, Dr. Md. Jahangir Alam, Dr. Mohammad Motiur Rahman, Dr. Md. Shakhawat Hussain, Dr. Dulal Chandra Ray, Dr. Saila Mazed, Dr. Minakshi Gupta, Dr. Mana Banik, Dr. Rozina Begum Chaya, Dr. Fariba Rashid, Dr. Pronab Choudhury, Dr. Biswajit Ray Chowdhury, Dr. Shahanaz Begum, Dr. Abdullah Al Mamun, Dr. Lalit Mohan Nath, Dr. S. M. Hasan Murad, Dr. Uttam Kumar Dey.

Acknowledgments

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work, and have given final approval for the version to be published. The authors thank Dr Punit Srivastava of Mediception Science Pvt. Ltd (www.mediception.com) for providing medical writing support during the preparation of this manuscript.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation. All authors took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.