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), 2024. Published by Science Publishing Group

Keywords

Ramadan Fasting, Empagliflozin, Vildagliptin

References

[1]	Babineaux SM, Toaima D, Boye KS, Zagar A, Tahbaz A, Jabbar A, et al. Multi-country retrospective observational study of the management and outcomes of patients with type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med 2015; 32: 819–28.
[2]	American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan; 44 (Suppl 1): S111-S124. doi: 10.2337/dc21-S009. PMID: 33298420.
[3]	Hassan A, Meo SA, Usmani AM, et al. Diabetes during Ramadan - PRE-approach model: presentation, risk stratification, education. Eur Rev Med Pharmacol Sci 2014; 18: 1798-805.
[4]	Bravis V, Hui E, Salih S, et al. Ramadan Education and Awareness in Diabetes (READ) programme for Muslims with Type 2 diabetes who fast during Ramadan. Diabet Med 2010; 27: 327-31.
[5]	Schweizer A, Halimi S, Dejager S. Experience with DPP-4 inhibitors in the management of patients with type 2 diabetes fasting during Ramadan. Vasc Health Risk Manag. 2014; 10: 15-24. doi: 10.2147/VHRM.S54585. Epub 2013 Dec 24. PMID: 24391442; PMCID: PMC3878957.
[6]	U.S. Food and Drug Administration. 2022. FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin \| FDA. [online] Available at: [Accessed 29 August 2022].
[7]	zBashier A, Khalifa A, Abdelgadir E, Al Saeed M, Al Qaysi A, Ali Bayati M et al. Safety of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2-I) During the Month of Ramadan in Muslim Patients with Type 2 Diabetes. Oman Medical Journal. 2018; 33 (2): 104-110.
[8]	Wan Seman W, Kori N, Rajoo S, Othman H, Mohd Noor N, Wahab N et al. Switching from sulphonylurea to a sodium-glucose cotransporter2 inhibitor in the fasting month of Ramadan is associated with a reduction in hypoglycaemia. Diabetes, Obesity and Metabolism. 2016; 18 (6): 628-632.
[9]	Minze MG, Will KJ, Terrell BT, Black RL, Irons BK. Benefits of SGLT2 Inhibitors Beyond Glycemic Control - A Focus on Metabolic, Cardiovascular and Renal Outcomes. Curr Diabetes Rev. 2018; 14 (6): 509-517.
[10]	McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Bělohlávek J, Böhm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjöstrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21; 381 (21): 1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19. PMID: 31535829.
[11]	Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Böhm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8; 383 (15): 1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28. PMID: 32865377.
[12]	Bhatt, D. L., Szarek, M., Steg, P. G., Cannon, C. P., Leiter, L. A., McGuire, D. K., Lewis, J. B., Riddle, M. C., Voors, A. A., Metra, M., Lund, L. H., Komajda, M., Testani, J. M., Wilcox, C. S., Ponikowski, P., Lopes, R. D., Verma, S., Lapuerta, P., & Pitt, B. (2021). Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. New England Journal of Medicine, 384 (2), 117-128.
[13]	Wanner C, Heerspink HJL, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, Hantel S, Woerle HJ, Broedl UC, von Eynatten M, Groop PH; EMPA-REG OUTCOME Investigators. Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial. J Am Soc Nephrol. 2018 Nov; 29 (11): 2755-2769. doi: 10.1681/ASN.2018010103. Epub 2018 Oct 12. PMID: 30314978; PMCID: PMC6218863.
[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
[15]	Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug; 7 (8): 606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10. Erratum in: Lancet Diabetes Endocrinol. 2019 Aug; 7 (8): e20. PMID: 31196815.
[16]	Hassanein M, Al-Arouj M, Hamdy O, Bebakar WM, Jabbar A, Al-Madani A, Hanif W, Lessan N, Basit A, Tayeb K, Omar MA. Diabetes and Ramadan: practical guidelines. Diabetes research and clinical practice. 2017 Apr 1; 126: 303-16.
[17]	Hassoun A, Al-Arouj M, Ibrahim M. The effect of vildagliptin relative to sulfonylurea as dual therapy with metformin (or as monotherapy) in Muslim patients with type 2 diabetes fasting during Ramadan in the Middle East: the VIRTUE study. Current Medical Research and Opinion. 2016; 33 (1): 161-167.
[18]	Devendra D, Gohel B, Bravis V, Hui E, Salih S, Mehar S, Hassanein M. Vildagliptin therapy and hypoglycaemia in Muslim type 2 diabetes patients during Ramadan. Int J Clin Pract. 2009 Oct; 63 (10): 1446-50. doi: 10.1111/j.1742-1241.2009.02171.x. Epub 2009 Aug 12. PMID: 19678856.
[19]	Al Sifri S, Basiounny A, Echtay A, et al. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011; 65 (11): 1132-1140. doi: 10.1111/j.1742-1241.2011.02797.x.
[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.
[21]	Committee for Medicinal Products for Human Use. European Public Assessment Report (EPAR) Canagliflozin. European Medicines Agency 2013. EMA/374133/2013.
[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.
[25]	Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naïve patients with type 2 diabetes. Horm Metab Res. 2009 Dec; 41 (12): 905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24. Erratum in: Horm Metab Res. 2009 Dec; 41 (12): 909. PMID: 19705345.
[26]	Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013 Sep-Oct; 27 (5): 479-84. doi: 10.1016/j.jdiacomp.2013.04.012. Epub 2013 Jun 24. PMID: 23806570.

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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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