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 language | English |
|---|---|
| Pages (from-to) | 1697-1699 |
| Number of pages | 3 |
| Journal | Transplantation Proceedings |
| Volume | 37 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - May 2005 |
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ASJC Scopus subject areas
- Surgery
- Transplantation
Cite this
A "steroid-free" tacrolimus and low-dose mycophenolate mofetil primary immunosuppression does not prevent early acute rejection after liver transplantation. / Reggiani, P.; Arru, M.; Regazzi, M.; Gatti, S.; Molinaro, M. D.; Caccamo, L.; Maggi, U.; Melada, E.; Paone, G.; Rossi, G.
In: Transplantation Proceedings, Vol. 37, No. 4, 05.2005, p. 1697-1699.Research output: Contribution to journal › Article
}
TY - JOUR
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
Y1 - 2005/5
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.
AB - 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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U2 - 10.1016/j.transproceed.2005.02.111
DO - 10.1016/j.transproceed.2005.02.111
M3 - Article
VL - 37
SP - 1697
EP - 1699
JO - Transplantation Proceedings
JF - Transplantation Proceedings
SN - 0041-1345
IS - 4
ER -