Is minimal, [almost] steroid-free immunosuppression a safe approach in adult liver transplantation? Long-term outcome of a prospective, double blind, placebo-controlled, randomized, investigator-driven study.

Détails

ID Serval
serval:BIB_8791F321D911
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Is minimal, [almost] steroid-free immunosuppression a safe approach in adult liver transplantation? Long-term outcome of a prospective, double blind, placebo-controlled, randomized, investigator-driven study.
Périodique
Annals of Surgery
Auteur(s)
Lerut J.P., Pinheiro R.S., Lai Q., Stouffs V., Orlando G., Juri J.M., Ciccarelli O., Sempoux C., Roggen F.M., De Reyck C., Latinne D., Gianello P.
ISSN
1528-1140 (Electronic)
ISSN-L
0003-4932
Statut éditorial
Publié
Date de publication
2014
Peer-reviewed
Oui
Volume
260
Numéro
5
Pages
886-91; discussion 891-2
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Résumé
OBJECTIVE: To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT).
BACKGROUND: The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT.
METHODS: Between February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, double-blind, placebo-controlled minimization trial comparing tacrolimus placebo (TAC-PLAC) and TAC short-term steroid (TAC-STER) IS. All patients had a minimum clinical, biochemical, and histological follow-up of 5 years.
RESULTS: Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1% and 82.1% (P=0.89) and 74.2% and 76.9% (P=0.90), respectively. Five-year biopsies were available in 112 (89.6%) of 125 survivors. Twelve patients refused a biopsy because of their excellent evolution; tissue material was insufficient in 1 patient; 11 had normal liver tests; and 2 patients had developed alcoholic and secondary biliary cirrhosis. Histology was normal in 44 (39.3%) patients; 35 (31.3%) had disease recurrence. The remaining biopsies showed nonspecific chronic hepatitis (14.3%), mild inflammatory infiltrates (10.7%), and steatosis (3.5%). All findings were equally distributed between both groups. In each group, 3 patients (4.8%) presented with acute cellular rejection after the first year and only 1 (0.9%) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis. Arterial hypertension, diabetes mellitus, renal insufficiency, hypercholesterolemia, gout, and obesity were equally low in both groups.
CONCLUSIONS: Excellent long-term results can be obtained under minimal IS and absence of steroids. TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up.
Pubmed
Web of science
Création de la notice
16/01/2015 13:01
Dernière modification de la notice
03/03/2018 19:02
Données d'usage