Premium
A prospective randomized open study in liver transplant recipients: Daclizumab, mycophenolate mofetil, and tacrolimus versus tacrolimus and steroids
Author(s) -
Otero Alejandra,
Varo Evaristo,
de Urbina Jorge Ortiz,
MartínVivaldi Rafael,
CuervasMons Valentin,
GonzálezPinto Ignacio,
Rimola Antoni,
Bernardos Angel,
Otero Santiago,
Maldonado Jorge,
Herrero Jose I.,
Barrao Elena,
DomínguezGranados Rosa
Publication year - 2009
Publication title -
liver transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.814
H-Index - 150
eISSN - 1527-6473
pISSN - 1527-6465
DOI - 10.1002/lt.21854
Subject(s) - medicine , daclizumab , tacrolimus , regimen , liver transplantation , gastroenterology , mycophenolate , mycophenolic acid , urology , transplantation
This open‐label, randomized study compared the efficacy of a regimen of corticosteroids and tacrolimus (standard therapy group, n = 79) with a regimen of daclizumab induction therapy in combination with mycophenolate mofetil and tacrolimus (modified therapy group, n = 78) in primary liver transplant recipients. The primary endpoint was biopsy‐proven acute rejection (BPAR) at 24 weeks. Secondary endpoints included time to rejection and patient and graft survival. The incidence of BPAR was significantly reduced in the modified therapy group compared to the standard therapy group (11.5% versus 26.6%, respectively, P = 0.017). The time to rejection was significantly shorter in the standard therapy group compared with the modified therapy group ( P = 0.044). There was no significant difference between groups in patient or graft survival. Hepatitis C virus–positive patients exhibited no differences from hepatitis C virus–negative patients with respect to the incidence of BPAR. A steroid‐sparing regimen of daclizumab, mycophenolate mofetil, and tacrolimus was effective and well tolerated in the prevention of BPAR in adult liver transplant recipients in comparison with a standard regimen of tacrolimus and steroids. Liver Transpl 15:1542–1552, 2009. © 2009 AASLD.