Bzeizi KI, Albenmousa A, Shawkat M, Ahmed Z, Alabbad S, Al-Hamoudi W, Troisi R, Broering D. Efficacy and safety of once daily tacrolimus compared to twice daily tacrolimus after liver transplantation. World J Hepatol 2021; 13(3): 375-383 [PMID: 33815679 DOI: 10.4254/wjh.v13.i3.375]
Corresponding Author of This Article
Khalid Ibrahim Bzeizi, FRCP, Doctor, Department of Liver Transplantation, King Faisal Specialist Hospital and Research Center, Zahrawi Street, Al Maather, Riyadh 12713, Saudi Arabia. kbzeizi@kfshrc.edu.sa
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Meta-Analysis
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
World J Hepatol. Mar 27, 2021; 13(3): 375-383 Published online Mar 27, 2021. doi: 10.4254/wjh.v13.i3.375
Efficacy and safety of once daily tacrolimus compared to twice daily tacrolimus after liver transplantation
Khalid Ibrahim Bzeizi, Ali Albenmousa, Mohamed Shawkat, Zidan Ahmed, Saleh Alabbad, Waleed Al-Hamoudi, Roberto Troisi, Deiter Broering
Khalid Ibrahim Bzeizi, Ali Albenmousa, Department of Liver Transplantation, King Faisal Specialist Hospital and Research Center, Riyadh 12713, Saudi Arabia
Mohamed Shawkat, Department of Internal medicine, Faculty of Medicine, Minia University, Minia 1234, Egypt
Zidan Ahmed, Saleh Alabbad, Waleed Al-Hamoudi, Roberto Troisi, Department of Liver and Small Bowel Transplantation and Hepatobiliary-Pancreatic Surgery, King Faisal Specialist Hospital and Research Center, Riyadh 12713, Saudi Arabia
Deiter Broering, Organ Transplant Center, King Faisal Specialist Hosp and Res Ctr, Riyadh 11211, Saudi Arabia
Author contributions: Bzeizi K contributed to the conceptualization, data curation methodology, validation and writing both the original and revised manuscript; Al-Hamoudi W and Troisi R contributed to the conceptualization, validation and editing of the original manuscript; Shawakt M and Zidan A contributed to the data curation methodology, validation and editing of the original manuscript; Alabad S contributed to the validation and editing of the original manuscript; Albenmousa A contributed to the data curation methodology, validation and editing of the original manuscript; Broering D contributed to the conceptualization, validation and in the writing original manuscript; and all authors have read and approve the final manuscript.
Conflict-of-interest statement: The authors declare that no financial or any other conflict of interest is associated with this work.
PRISMA 2009 Checklist statement: The guidelines of the PRISMA 2009 statement have been adopted.
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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Khalid Ibrahim Bzeizi, FRCP, Doctor, Department of Liver Transplantation, King Faisal Specialist Hospital and Research Center, Zahrawi Street, Al Maather, Riyadh 12713, Saudi Arabia. kbzeizi@kfshrc.edu.sa
Received: November 5, 2020 Peer-review started: November 5, 2020 First decision: November 30, 2020 Revised: January 4, 2021 Accepted: February 18, 2021 Article in press: February 18, 2021 Published online: March 27, 2021 Processing time: 134 Days and 13.6 Hours
ARTICLE HIGHLIGHTS
Research background
Tacrolimus, a calcineurin inhibitor is an important immunosuppressive medication post liver transplantation. Compliance to immunosuppression is important and non-adherence can lead to rejection and graft loss. To maintain good adherence, less frequently administering regimen were proved to be effective.
Research motivation
Recently, tacrolimus once-daily prolonged-release (PR) formulation was developed. Several studies have shown evidence that conversion from the twice-daily, immediate release to PR tacrolimus was well tolerated, safe and conveniently used in stable patients after liver transplantation.
Research objectives
Our objective was to conduct a metanalysis and systematic review of the published clinical trials that studied the safety and efficacy of PR tacrolimus compared to immediate release tacrolimus.
Research methods
MEDLINE, EMBASE, CENTRAL databases were searched for clinical trials until December 2020. Efficacy outcome measured as the rate of treatment failure indicated by biopsy-proven acute rejection, Serum creatinine, graft loss, or death. Two reviewers independently selected studies, collected data and assessed risk of bias. The results are reported as risk ratio with 95%CI for dichotomous data.
Research results
Seven studies included with 965 patients. All the included studies were of moderate quality according to the risk of bias assessment using Cochrane Risk of Bias tool. Biopsy-proven acute rejection was reported in four studies, and pooled analysis of those studies indicated similar rejections in both twice daily and once daily tacrolimus groups. We also found no significant difference between both groups for renal outcome (serum creatinine; mean difference, 0.001 mg/dL, 95%CI: -0.042 to 0.043, n = 846, I2 = 18.6%). Similarly, there was similar number of adverse events such as hypertension, headache, back pain, blood related disorders, infections and nausea observed in both groups.
Research conclusions
The analysis findings confirm that both once daily and twice daily tacrolimus formulations are comparable in terms of efficacy and safety outcomes.
Research perspectives
Long-term follow-up randomized controlled trials with large sample sizes are required. Also, to assess acceptability by patients, quality of life and economic evaluations should be conducted.
