Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Exp Med. Dec 20, 2024; 14(4): 95272
Published online Dec 20, 2024. doi: 10.5493/wjem.v14.i4.95272
Dapagliflozin as an oral antihyperglycemic agent in the management of diabetes mellitus in patients with liver cirrhosis
Zeinab Seif El-Din, Mohammed Afify, Essam Zayed, Dalia Elsabaawy, El Sayed Tharwa, Ahmed Elsharawy, Eman Abdelsameea, Mohamed Akl Rady
Zeinab Seif El-Din, Mohammed Afify, Essam Zayed, El Sayed Tharwa, Eman Abdelsameea, Mohamed Akl Rady, Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebin El-Kom 32511, Egypt
Dalia Elsabaawy, Department of Clinical Pharmacy, Pharmacy College, Menoufia University, Shebin El-Kom 32511, Egypt
Ahmed Elsharawy, Department of Clinical Pathology, National Liver Institute, Menoufia University, Shebin El-Kom 32511, Egypt
Author contributions: Tharwa ES initiated the project and designed and implemented the study for application; Seif El-Din Z, Afify M, Zayed E, Elsabaawy D, Elsharawey A Abdelsameea E, and Rady MA analyzed the data and drafted and revised the paper; All authors have read, revised, and approved the final manuscript.
Institutional review board statement: This study was reviewed and approved by the institutional review board of National Liver Institute, Menoufia University (IRB number: 00248/2021).
Clinical trial registration statement: This study did not require a clinical trial enrollment.
Informed consent statement: All patients who participated in this study provided written informed consent.
Conflict-of-interest statement: All authors declare that they have no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Eman Abdelsameea, MD, Editor-in-Chief, Full Professor, Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, National Liver Institute, Menoufia University, Gamal Abd-Elnasser Street, Shebin El-Kom 32511, Egypt. eabdelsameea@liver-eg.org
Received: April 10, 2024
Revised: August 18, 2024
Accepted: August 28, 2024
Published online: December 20, 2024
Processing time: 203 Days and 9.6 Hours
Abstract
BACKGROUND

The use of dapagliflozin in patients with cirrhosis has been relatively restricted due to concerns regarding its overall safety and pharmacological profile in this population.

AIM

To determine the safety and effectiveness of dapagliflozin in the co-management of diabetes mellitus and cirrhosis with or without ascites.

METHODS

The patients studied were divided into two groups: 100 patients in the control group received insulin, while 200 patients received dapagliflozin. These patients were classified as Child A, B, or C based on the Child–Pugh classification. Child A or B and Child C were administered doses of 10 mg and 5 mg of dapagliflozin, respectively.

RESULTS

The rate of increased diuretics dose was markedly elevated in the group that received insulin compared to the group that received dapagliflozin. In addition, dapagliflozin treatment substantially reduced weight, body mass index, and fasting blood glucose compared to the insulin group during follow-up. However, there were no significant differences in hemoglobin A1c, liver function, or laboratory investigations between both groups during the follow-up period. The incidence of hypoglycemia, hepatic encephalopathy, variceal bleeding, and urinary tract infection was significantly higher in the insulin group compared to the dapagliflozin group. In contrast, the dapagliflozin group experienced significantly higher rates of frequent urination and dizziness. In addition, the insulin group exhibited a marked worsening of ascites compared to the dapagliflozin group.

CONCLUSION

Dapagliflozin demonstrated safety and efficacy in the treatment of diabetic patients who have cirrhosis with or without ascites. This resulted in an improvement of ascites, as well as a decrease in diuretic dose and Child–Pugh score.

Keywords: Dapagliflozin; Cirrhosis; Diabetes mellitus; Hemoglobin; Liver diseases

Core Tip: To assess the effectiveness and safety of dapagliflozin in the co-management diabetes mellitus and cirrhosis with or without ascites, patients were categorized into a control group of 100 patients administered insulin and 200 patients administered dapagliflozin. On follow-up, there was a significantly higher incidence of hypoglycemia, hepatic encephalopathy, variceal bleeding, and urinary tract infection in the insulin group than in the dapagliflozin group. Frequent micturition and vertigo were significantly higher in the dapagliflozin group. Dapagliflozin demonstrated safety and efficacy in the treatment of diabetic patients with cirrhosis, leading to improvement of ascites, decrease in diuretic dose, and Child–Pugh score.