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

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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

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Mycophenolic Acid
Tacrolimus
Liver Transplantation
Immunosuppression
Steroids
Immunosuppressive Agents
Survival Rate
Transplantation
Ethical Analysis
Graft Survival
Postoperative Period
Morbidity
Transplants
Safety
Survival

ASJC Scopus subject areas

  • Surgery
  • Transplantation

Cite this

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title = "A {"}steroid-free{"} tacrolimus and low-dose mycophenolate mofetil primary immunosuppression does not prevent early acute rejection after liver transplantation",
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.",
author = "P. Reggiani and M. Arru and M. Regazzi and S. Gatti and Molinaro, {M. D.} and L. Caccamo and U. Maggi and E. Melada and G. Paone and G. Rossi",
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T1 - A "steroid-free" tacrolimus and low-dose mycophenolate mofetil primary immunosuppression does not prevent early acute rejection after liver transplantation

AU - Reggiani, P.

AU - Arru, M.

AU - Regazzi, M.

AU - Gatti, S.

AU - Molinaro, M. D.

AU - Caccamo, L.

AU - Maggi, U.

AU - Melada, E.

AU - Paone, G.

AU - Rossi, G.

PY - 2005/5

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N2 - 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.

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