An open, randomized, multicenter clinical trial of oral tacrolimus in liver allograft transplantation: A comparison of dual vs. triple drug therapy

✍ Scribed by Miguel García González; Carlos Pera Madrazo; Ángel Bernardos Rodríguez; Manuel Gómez Gutiérrez; J. Ignacio Herrero; José Mir Pallardó; Jorge Ortiz de Urbina; Pascual Parrilla Paricio

• Publisher: John Wiley and Sons
• Year: 2005
• Tongue: English
• Weight: 116 KB
• Volume: 11
• Category: Article
• ISSN: 1527-6465
• DOI: 10.1002/lt.20382

✦ Synopsis

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 biopsyproven 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