The evaluation of enteric-coated mycophenolate sodium in cardiac deceased donor liver transplant patients in China
Authors: Shusen Zheng
Bingyi Lin
Zuoyi Wang
J J He
Lei Geng
Lin Zhang
X Y Liu
Journal: Immunopharmacology and immunotoxicology (2015)
Discipline: IMMUNOLOGY
Keywords: Donation after cardiac death; enteric-coated mycophenolate sodium; liver transplantation; mycophenolate mofetil.
Affiliations: a Division of Hepatobiliary and Pancreatic Surgery , Department of Surgery, Key Laboratory of Combined Multi-Organ Transplantation, Ministry of Public Health, Zhejiang Province, First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou , China.

Abstract:  Objective: The management of liver receivers requires intense immunosuppression to prevent graft rejection. Mycophenolate mofetil (MMF) is a common immunosuppressant but frequently suffer dose reduction for gastrointestinal adverse reactions (GI). Hence, the enteric-coated mycophenolate sodium (EC-MPS) is introduced as a substitute for MMF to reduce GI. The study was designed to investigate the efficacy, safety and exposure equation of EC-MPS in liver transplant patients in China. Methods: Ninety-two liver receivers who administered EC-MPS or MMF as a primary immunosuppressant were enrolled in this single-center study and divided into MMF group and EC-MPC group, respectively. Efficacy and safety of EC-MPS were compared with MMF. The MPA exposure was measured at time 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 h after mean 4.5 days of EC-MPS treatment. An equation of limited time points for estimating serum MPA exposure of EC-MPS was established using multiple stepwise regression model. Results: Data show an interpatient variation in MPA AUC, Cmax and Tmax. After a first dose of EC-MPS, the mean value of serum AUC0-12 h was 20.68 mg/L (SD 8.94, range 8.1-46.3). Cmax was 9.7 mg/L (SD 6.48, range 2.7-16.3); Tmax was 1.90 h (SD 0.97, range 0.5-4). The best equation for estimating the AUC was 6.0 1 4 + 0.946C2 + 0.606C3 + 1.154C4 + 2.479C6 + 5.07C12. Comparing with MMF, EC-MPS not only effectively maintained immunosuppression, but also had similar incidences of infection, renal dysfunction and hematological disorders. However, EC-MPS markedly improved GI, the incidence of GI was half of the MMF group. Conclusion: This analysis presented that EC-MPS is an effective and safe immunosuppressant as similar as MMF. The conversion of MMF to EC-MPS could be administered. 

Retracted: No

PubPeer comments:
 2020 Expression of Concern https: www.tandfonline.com doi full 10.1080 08923973.2020.1750754 This article refers to: The evaluation of enteric-coated mycophenolate sodium in cardiac deceased donor liver transplant patients in China Concerns have been raised that the study described in the article did not adhere to ethical guidelines as outlined in the Declaration of Helsinki and the Declaration of Istanbul and guidance from the World Health Organization and the World Medical Association regarding the source of transplanted human organs. Specifically, the British Medical Journal Open (BMJ Open) published an article highlighting many papers in which there is concern that transplanted organs were harvested from executed prisoners in China. In response to these concerns we contacted the authors to clarify the source of the transplanted organs received by the patients described in their study. However, despite multiple attempts to contact the authors and their institutions, no response was received. The Editors of Immunopharmacology and Immunotoxicology would like to alert readers of this. We will provide an update if we receive any further information. Immunopharmacology and Immunotoxicology publishes research adhering to internationally accepted ethical standards and is committed to upholding the Declaration of Helsinki and Declaration of Istanbul. Taylor Francis endorses the ethics guidelines described by the World Health Organization (WHO) and the World Medical Association (WMA ,