검색
검색 팝업 닫기

Ex) Article Title, Author, Keywords

Article

original article

Pharmacoepidemiology and Risk Management 2024; 16(2): 182-191

Published online September 30, 2024 https://doi.org/10.56142/perm.24.0017

Copyright © Korean Society for Pharmacoepidemiology and Risk Management.

Effectiveness and Safety of Tacrolimus-Mycophenolate Combination Therapy vs. Tacrolimus Monotherapy in Pediatric Liver Transplantation

소아 간이식 환자에서 tacrolimus-mycophenolate 병용요법과 tacrolimus 단독요법의 효과 및 안전성 비교 분석

Seung-Yeon Cheon1,2, Jong-hyun Jeong2, Jeong-Yun Choi1, Eun-Jung Cho1, Jin-Hee Baek1, Nam-Joon Yi3, Ju-Yeun Lee4

천승연1,2, 정종현2, 최정윤1, 조은정1, 백진희1, 이남준3, 이주연4

1Department of Pharmacy, Seoul National University Hospital, Seoul, Korea
2College of Pharmacy, Seoul National University, Seoul, Korea
3Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
4College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea

1서울대학교병원 약제부, 2서울대학교 약학대학, 3서울대학교 의과대학, 4서울대학교 약학대학 및 약학연구소

Correspondence to:Nam-Joon Yi
Department of Surgery, Seoul National University College of Medicine, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Korea
Tel: +82-2-2072-2318
Fax: +82-2-766-3975
E-mail: gsleenj@snu.ac.kr

Ju-Yeun Lee
College of Pharmacy, Seoul National University, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea
Tel: +82-2-3668-7472
Fax: +82-2-3668-2728
E-mail: jypharm@snu.ac.kr

Received: August 21, 2024; Revised: September 21, 2024; Accepted: September 22, 2024

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective: The clinical outcome of mycophenolate (MPA) combined with tacrolimus in pediatric liver transplantation (LT) are not well understood. This study aimed to evaluate the effectiveness and safety of MPA and tacrolimus combination therapy compared to tacrolimus monotherapy in this population. Methods: This retrospective cohort study included pediatric LT patients who received at least 30 consecutive days of either tacrolimus and MPA (± steroid) combination therapy and their propensity score matched patients on tacrolimus (± steroid) monotherapy between 2010 and 2021. Incidence of acute rejection and immunosuppressantrelated adverse events (AEs) were compared between the two groups. Results: Among 130 pediatric LT patients, 32 were assigned to each group. Within one-year post-transplant, there were no statistically significant differences in acute rejection (9.4% vs. 12.5%; p = 0.502) or overall AEs (84.4% vs. 65.6%; p = 0.149) between the combination and control groups. However, a significantly higher rate of AEs leading to immunosuppressant discontinuation was observed in the combination group (62.5% vs. 3.1%; p < 0.001). No significant differences were found in severe infections, cytomegalovirus infections, post-transplant lymphoproliferative disease, or renal dysfunction. Although tacrolimus exposure was similar, the concentration/dose ratio was lower in the combination group at 1 month (1.8 ± 5.4 vs. 3.4 ± 3.8, p = 0.040). Conclusion: While acute rejection and overall AE rates did not differ significantly between the two groups, the MPA combination group had a higher rate of therapy discontinuation due to AEs. Further studies with larger populations are needed to confirm these findings.

KeywordsPediatric, Liver transplant, Tacrolimus, Mycophenolate, Acute rejection, Adverse events

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.2
September, 2024

eISSN 2982-5954

Frequency: Bimonthly

Current Issue   |   Archives

Supplementary File

Stats or Metrics

Share this article on :

  • line