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An open, randomized, multicenter clinical trial of oral tacrolimus in liver allograft transplantation: A comparison of dual vs. triple drug therapy
Author(s) -
García González Miguel,
Pera Madrazo Carlos,
Bernardos Rodríguez Ángel,
Gómez Gutiérrez Manuel,
Herrero J. Ignacio,
Mir Pallardó José,
Ortiz de Urbina Jorge,
Parrilla Paricio Pascual
Publication year - 2005
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.20382
Subject(s) - medicine , tacrolimus , liver transplantation , azathioprine , gastroenterology , randomized controlled trial , transplantation , clinical endpoint , incidence (geometry) , surgery , disease , physics , optics
Triple therapy combining an anticalcineurin agent, corticosteroids, and azathioprine (AZA) in liver transplantation has been frequently applied, particularly in Europe. Debates have arisen concerning the use of a third drug (AZA), mainly in patients receiving tacrolimus (TAC). An open‐label, multicenter, prospective, and randomized trial was performed to assess the efficacy and safety of TAC and corticosteroids (dual therapy [D]) vs. TAC, corticosteroids, and AZA (triple therapy [T]) in liver transplantation. A total of 180 patients were randomized, 92 in D and 88 in T group. Patients were followed during 3 months for efficacy and safety and up to 24 months for patient and graft survival assessments. The rate of biopsy‐proven acute rejection was higher in D than in T group (40.7% vs. 24.4%; P = 0.021). A higher incidence of positive HCV status in D group (55.6% vs. 40.7%; P = 0.049) may explain this difference, since significantly more patients of this HCV subpopulation experienced acute rejection when treated with D therapy (48% vs. 20%; P = 0.008). No treatment differences were apparent for HCV‐negative patients. The 24‐month graft survival tended to be inferior in T group, 69.8% vs. 75.8% ( P = 0.283). Similar results were observed regarding patient survival at the same time point, with values of 72.9% vs. 76.9% ( P = 0.573), favoring D group. Both regimens showed comparable safety profiles with the exception of hematological abnormalities, which were more frequently observed in T group. In conclusion, both regimens were shown to be effective although increased toxicity and a trend towards a lower graft and patient survival were observed in T group. (Liver Transpl 2005;11:515–524.)