A "steroid-free" tacrolimus and low-dose mycophenolate mofetil primary immunosuppression does not prevent early acute rejection after liver transplantation

P. Reggiani, M. Arru, M. Regazzi, S. Gatti, M. D. Molinaro, L. Caccamo, U. Maggi, E. Melada, G. Paone, G. Rossi

Research output: Contribution to journalArticlepeer-review

Abstract

To assess the efficacy and safety of a primary immunosuppressive regimen with tacrolimus (Tac) and low-dose mycophenolate mofetil (MMF) without steroids and to determine the exposure to mycophenolic acid (MPA) in the early postoperative period, we performed a single-center, randomized 1:1, open-label, controlled study planned to be 60 liver transplantation patients randomized into 2 groups: group A, tacrolimus + MMF (750 mg orally twice a day); and group B, tacrolimus + MMF (750 mg orally twice a day) + steroids. After an interim analysis by the ethical committee patient enrollment was stopped. Data from 30 patients (12 in group A and 18 in group B with a mean follow-up period of 31 ± 7 months) showed a patient survival rate of 91.7% in group A and 100% in group B and a graft survival rate of 91.7% and 88.9%, respectively. Nine patients (75%) in group A suffered an acute rejection episode, whereas in group B only 3 patients (16.7%) showed acute rejection (P =. 002). All rejection episodes occurred in both groups at 1 week after transplantation. The difference in histological grading was statistically significant (P =. 021). The toxicity profiles were similar in both groups. A primary immunosuppressive regimen based on Tac and low-dose MMF without steroids is safe but unable to prevent acute rejection at 1 week after transplantation even if early acute rejection does not affect the outcome in terms of morbidity and graft or patient survival.

Original languageEnglish
Pages (from-to)1697-1699
Number of pages3
JournalTransplantation Proceedings
Volume37
Issue number4
DOIs
Publication statusPublished - May 2005

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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