Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)

Hesham El Hefnawy; Mohamed Abdel Hady Mashahit; Khaled El Sayed El Hadidy; Heba Ramadan; Athar Reda Ibrahim; Amany Kamel; Hazem Samy Matar; Abdelrahman Ahmed Ewaise

doi:doi:10.11648/j.ijde.20220703.17

Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)

Hesham El Hefnawy, Mohamed Abdel Hady Mashahit, Khaled El Sayed El Hadidy, Heba Ramadan, Athar Reda Ibrahim, Amany Kamel, Hazem Samy Matar, Abdelrahman Ahmed Ewaise

Published in International Journal of Diabetes and Endocrinology (Volume 7, Issue 3)

Received: 17 August 2022 Accepted: 2 September 2022 Published: 14 September 2022

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Abstract

This is a multicenter, observational, comparative, phase IV study, conducted to assess safety and efficacy of sodium glucose cotransporter 2 inhibitors (SGLT2 I) versus dipeptidyl peptidase 4 inhibitors (DPP-4 I), added to biguanides for both groups, in managing Type 2 Diabetes Mellitus (T2DM) during Ramadan fasting among Muslim Egyptian patients. All patients aged ≥ 18 years old, on SGLT2-inhibitor or DPP-4 inhibitor added on metformin for at least one month before Ramadan, willing to fast Ramadan. Demographic data, detailed medical history and laboratory results were collected before and after Ramadan. Out of 300 enrolled patients, three patients from group B (DPP-4 inhibitor) had mild hypoglycemic episodes and none in group A (SGLT2 inhibitor). Mean HbA1c markedly decreased after Ramadan fasting in Group A with a statistically significant difference (p-value = 0.021) and decreased in group B with no statistical significance (p-value = 0.365). Both medications demonstrated weight loss in patients, with a very highly statistically significant difference between both groups (p-value < 0.001). There was urinary tract infection (UTI) in both groups, with no statistical significance. No diabetic ketoacidosis was reported in the study. 6 (3.8%) of total patients in group A and 11 (7.7%) in group B had adverse events as; UTI, hypoglycemia, and genital infection. All AEs were mild to moderate and not related to medications of the trial. No serious adverse events (SAEs) were reported in the study. Both SGLT2 inhibitors and DPP4 inhibitors are safe to be used and effective in the management of T2DM during Ramadan Fasting.

Published in	International Journal of Diabetes and Endocrinology (Volume 7, Issue 3)
DOI	10.11648/j.ijde.20220703.17
Page(s)	81-90
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2022. Published by Science Publishing Group

Keywords

Ramadan Fasting, Empagliflozin, Vildagliptin

References

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[14]	Carbone, S., Dixon, D. L. The CANVAS Program: implications of canagliflozin on reducing cardiovascular risk in patients with type 2 diabetes mellitus. Cardiovasc Diabetol 18, 64 (2019). https://doi.org/10.1186/s12933-019-0869-2
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[20]	Nauck MA, Del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep; 34 (9): 2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4. PMID: 21816980; PMCID: PMC3161265.
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[22]	List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009 Apr; 32 (4): 650-7. doi: 10.2337/dc08-1863. Epub 2008 Dec 29. PMID: 19114612; PMCID: PMC2660449.
[23]	Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014; 37 (3): 740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21. PMID: 24144654.
[24]	Scheen AJ. Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs. 2015 Jan; 75 (1): 33-59. doi: 10.1007/s40265-014-0337-y. PMID: 25488697.
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APA Style

Hesham El Hefnawy, Mohamed Abdel Hady Mashahit, Khaled El Sayed El Hadidy, Heba Ramadan, Athar Reda Ibrahim, et al. (2022). Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). International Journal of Diabetes and Endocrinology, 7(3), 81-90. https://doi.org/10.11648/j.ijde.20220703.17

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ACS Style

Hesham El Hefnawy; Mohamed Abdel Hady Mashahit; Khaled El Sayed El Hadidy; Heba Ramadan; Athar Reda Ibrahim, et al. Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). Int. J. Diabetes Endocrinol. 2022, 7(3), 81-90. doi: 10.11648/j.ijde.20220703.17

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AMA Style

Hesham El Hefnawy, Mohamed Abdel Hady Mashahit, Khaled El Sayed El Hadidy, Heba Ramadan, Athar Reda Ibrahim, et al. Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). Int J Diabetes Endocrinol. 2022;7(3):81-90. doi: 10.11648/j.ijde.20220703.17

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@article{10.11648/j.ijde.20220703.17,
  author = {Hesham El Hefnawy and Mohamed Abdel Hady Mashahit and Khaled El Sayed El Hadidy and Heba Ramadan and Athar Reda Ibrahim and Amany Kamel and Hazem Samy Matar and Abdelrahman Ahmed Ewaise},
  title = {Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)},
  journal = {International Journal of Diabetes and Endocrinology},
  volume = {7},
  number = {3},
  pages = {81-90},
  doi = {10.11648/j.ijde.20220703.17},
  url = {https://doi.org/10.11648/j.ijde.20220703.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijde.20220703.17},
  abstract = {This is a multicenter, observational, comparative, phase IV study, conducted to assess safety and efficacy of sodium glucose cotransporter 2 inhibitors (SGLT2 I) versus dipeptidyl peptidase 4 inhibitors (DPP-4 I), added to biguanides for both groups, in managing Type 2 Diabetes Mellitus (T2DM) during Ramadan fasting among Muslim Egyptian patients. All patients aged ≥ 18 years old, on SGLT2-inhibitor or DPP-4 inhibitor added on metformin for at least one month before Ramadan, willing to fast Ramadan. Demographic data, detailed medical history and laboratory results were collected before and after Ramadan. Out of 300 enrolled patients, three patients from group B (DPP-4 inhibitor) had mild hypoglycemic episodes and none in group A (SGLT2 inhibitor). Mean HbA1c markedly decreased after Ramadan fasting in Group A with a statistically significant difference (p-value = 0.021) and decreased in group B with no statistical significance (p-value = 0.365). Both medications demonstrated weight loss in patients, with a very highly statistically significant difference between both groups (p-value < 0.001). There was urinary tract infection (UTI) in both groups, with no statistical significance. No diabetic ketoacidosis was reported in the study. 6 (3.8%) of total patients in group A and 11 (7.7%) in group B had adverse events as; UTI, hypoglycemia, and genital infection. All AEs were mild to moderate and not related to medications of the trial. No serious adverse events (SAEs) were reported in the study. Both SGLT2 inhibitors and DPP4 inhibitors are safe to be used and effective in the management of T2DM during Ramadan Fasting.},
 year = {2022}
}

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TY  - JOUR
T1  - Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)
AU  - Hesham El Hefnawy
AU  - Mohamed Abdel Hady Mashahit
AU  - Khaled El Sayed El Hadidy
AU  - Heba Ramadan
AU  - Athar Reda Ibrahim
AU  - Amany Kamel
AU  - Hazem Samy Matar
AU  - Abdelrahman Ahmed Ewaise
Y1  - 2022/09/14
PY  - 2022
N1  - https://doi.org/10.11648/j.ijde.20220703.17
DO  - 10.11648/j.ijde.20220703.17
T2  - International Journal of Diabetes and Endocrinology
JF  - International Journal of Diabetes and Endocrinology
JO  - International Journal of Diabetes and Endocrinology
SP  - 81
EP  - 90
PB  - Science Publishing Group
SN  - 2640-1371
UR  - https://doi.org/10.11648/j.ijde.20220703.17
AB  - This is a multicenter, observational, comparative, phase IV study, conducted to assess safety and efficacy of sodium glucose cotransporter 2 inhibitors (SGLT2 I) versus dipeptidyl peptidase 4 inhibitors (DPP-4 I), added to biguanides for both groups, in managing Type 2 Diabetes Mellitus (T2DM) during Ramadan fasting among Muslim Egyptian patients. All patients aged ≥ 18 years old, on SGLT2-inhibitor or DPP-4 inhibitor added on metformin for at least one month before Ramadan, willing to fast Ramadan. Demographic data, detailed medical history and laboratory results were collected before and after Ramadan. Out of 300 enrolled patients, three patients from group B (DPP-4 inhibitor) had mild hypoglycemic episodes and none in group A (SGLT2 inhibitor). Mean HbA1c markedly decreased after Ramadan fasting in Group A with a statistically significant difference (p-value = 0.021) and decreased in group B with no statistical significance (p-value = 0.365). Both medications demonstrated weight loss in patients, with a very highly statistically significant difference between both groups (p-value < 0.001). There was urinary tract infection (UTI) in both groups, with no statistical significance. No diabetic ketoacidosis was reported in the study. 6 (3.8%) of total patients in group A and 11 (7.7%) in group B had adverse events as; UTI, hypoglycemia, and genital infection. All AEs were mild to moderate and not related to medications of the trial. No serious adverse events (SAEs) were reported in the study. Both SGLT2 inhibitors and DPP4 inhibitors are safe to be used and effective in the management of T2DM during Ramadan Fasting.
VL  - 7
IS  - 3
ER  -

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Author Information

Hesham El Hefnawy

Departement of Pediatric Endocrinology and Diabetes, National Institute for Diabetes and Endocrinology, Cairo, Egypt
Mohamed Abdel Hady Mashahit

Department of Internal Medicine, Fayuom University Hospitals, Fayoum, Egypt
Khaled El Sayed El Hadidy

Department of Internal Medicine, Beni-Suef University Hospitals, Beni-Suef, Egypt
Heba Ramadan

Department of Internal Medicine, National Institute for Diabetes and Endocrinology, Cairo, Egypt
Athar Reda Ibrahim

Departement of Pediatric Endocrinology and Diabetes, National Institute for Diabetes and Endocrinology, Cairo, Egypt
Amany Kamel

Department of Internal Medicine, National Institute for Diabetes and Endocrinology, Cairo, Egypt
Hazem Samy Matar

Department of Internal Medicine, Beni-Suef University Hospitals, Beni-Suef, Egypt
Abdelrahman Ahmed Ewaise

Department of Internal Medicine, Fayuom University Hospitals, Fayoum, Egypt

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APA Style

Hesham El Hefnawy, Mohamed Abdel Hady Mashahit, Khaled El Sayed El Hadidy, Heba Ramadan, Athar Reda Ibrahim, et al. (2022). Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). International Journal of Diabetes and Endocrinology, 7(3), 81-90. https://doi.org/10.11648/j.ijde.20220703.17

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ACS Style

Hesham El Hefnawy; Mohamed Abdel Hady Mashahit; Khaled El Sayed El Hadidy; Heba Ramadan; Athar Reda Ibrahim, et al. Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). Int. J. Diabetes Endocrinol. 2022, 7(3), 81-90. doi: 10.11648/j.ijde.20220703.17

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AMA Style

Hesham El Hefnawy, Mohamed Abdel Hady Mashahit, Khaled El Sayed El Hadidy, Heba Ramadan, Athar Reda Ibrahim, et al. Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan). Int J Diabetes Endocrinol. 2022;7(3):81-90. doi: 10.11648/j.ijde.20220703.17

Copy | Download

@article{10.11648/j.ijde.20220703.17,
  author = {Hesham El Hefnawy and Mohamed Abdel Hady Mashahit and Khaled El Sayed El Hadidy and Heba Ramadan and Athar Reda Ibrahim and Amany Kamel and Hazem Samy Matar and Abdelrahman Ahmed Ewaise},
  title = {Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)},
  journal = {International Journal of Diabetes and Endocrinology},
  volume = {7},
  number = {3},
  pages = {81-90},
  doi = {10.11648/j.ijde.20220703.17},
  url = {https://doi.org/10.11648/j.ijde.20220703.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijde.20220703.17},
  abstract = {This is a multicenter, observational, comparative, phase IV study, conducted to assess safety and efficacy of sodium glucose cotransporter 2 inhibitors (SGLT2 I) versus dipeptidyl peptidase 4 inhibitors (DPP-4 I), added to biguanides for both groups, in managing Type 2 Diabetes Mellitus (T2DM) during Ramadan fasting among Muslim Egyptian patients. All patients aged ≥ 18 years old, on SGLT2-inhibitor or DPP-4 inhibitor added on metformin for at least one month before Ramadan, willing to fast Ramadan. Demographic data, detailed medical history and laboratory results were collected before and after Ramadan. Out of 300 enrolled patients, three patients from group B (DPP-4 inhibitor) had mild hypoglycemic episodes and none in group A (SGLT2 inhibitor). Mean HbA1c markedly decreased after Ramadan fasting in Group A with a statistically significant difference (p-value = 0.021) and decreased in group B with no statistical significance (p-value = 0.365). Both medications demonstrated weight loss in patients, with a very highly statistically significant difference between both groups (p-value < 0.001). There was urinary tract infection (UTI) in both groups, with no statistical significance. No diabetic ketoacidosis was reported in the study. 6 (3.8%) of total patients in group A and 11 (7.7%) in group B had adverse events as; UTI, hypoglycemia, and genital infection. All AEs were mild to moderate and not related to medications of the trial. No serious adverse events (SAEs) were reported in the study. Both SGLT2 inhibitors and DPP4 inhibitors are safe to be used and effective in the management of T2DM during Ramadan Fasting.},
 year = {2022}
}

Copy | Download

TY  - JOUR
T1  - Safety and Efficacy of SGLT2 Inhibitors Versus DPP4 Inhibitors in Fasting Patients with T2-Diabetes Mellitus During Ramadan in Egypt (EMPA-Ramadan)
AU  - Hesham El Hefnawy
AU  - Mohamed Abdel Hady Mashahit
AU  - Khaled El Sayed El Hadidy
AU  - Heba Ramadan
AU  - Athar Reda Ibrahim
AU  - Amany Kamel
AU  - Hazem Samy Matar
AU  - Abdelrahman Ahmed Ewaise
Y1  - 2022/09/14
PY  - 2022
N1  - https://doi.org/10.11648/j.ijde.20220703.17
DO  - 10.11648/j.ijde.20220703.17
T2  - International Journal of Diabetes and Endocrinology
JF  - International Journal of Diabetes and Endocrinology
JO  - International Journal of Diabetes and Endocrinology
SP  - 81
EP  - 90
PB  - Science Publishing Group
SN  - 2640-1371
UR  - https://doi.org/10.11648/j.ijde.20220703.17
AB  - This is a multicenter, observational, comparative, phase IV study, conducted to assess safety and efficacy of sodium glucose cotransporter 2 inhibitors (SGLT2 I) versus dipeptidyl peptidase 4 inhibitors (DPP-4 I), added to biguanides for both groups, in managing Type 2 Diabetes Mellitus (T2DM) during Ramadan fasting among Muslim Egyptian patients. All patients aged ≥ 18 years old, on SGLT2-inhibitor or DPP-4 inhibitor added on metformin for at least one month before Ramadan, willing to fast Ramadan. Demographic data, detailed medical history and laboratory results were collected before and after Ramadan. Out of 300 enrolled patients, three patients from group B (DPP-4 inhibitor) had mild hypoglycemic episodes and none in group A (SGLT2 inhibitor). Mean HbA1c markedly decreased after Ramadan fasting in Group A with a statistically significant difference (p-value = 0.021) and decreased in group B with no statistical significance (p-value = 0.365). Both medications demonstrated weight loss in patients, with a very highly statistically significant difference between both groups (p-value < 0.001). There was urinary tract infection (UTI) in both groups, with no statistical significance. No diabetic ketoacidosis was reported in the study. 6 (3.8%) of total patients in group A and 11 (7.7%) in group B had adverse events as; UTI, hypoglycemia, and genital infection. All AEs were mild to moderate and not related to medications of the trial. No serious adverse events (SAEs) were reported in the study. Both SGLT2 inhibitors and DPP4 inhibitors are safe to be used and effective in the management of T2DM during Ramadan Fasting.
VL  - 7
IS  - 3
ER  -

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