BACKGROUND: @entity1140 ( @entity11636 ) and @entity6051 mofetil ( @entity2098 ) are currently approved immunosuppressants for prevention of rejection in liver transplantation (LTx). They have different modes of action and @entity137 profiles, but the efficacy and safety of @entity2098 in primary liver transplantation with @entity11636 has not been determined. METHODS: An Institutional Review Board-approved, open-label, single-center, prospective randomized trial was initiated to study the efficacy and @entity137 of @entity11636 and @entity230 (double-drug therapy (D)) versus @entity11636 , @entity230 , and @entity2098 (triple-drug therapy (T)) in primary adult LTx recipients. Both groups of @entity1 were started on the same doses of @entity11636 and @entity230 . @entity1 randomized to T also received 1 gm @entity2098 twice a day. RESULTS: Between August 1995 and May 1998, 350 @entity1 were enrolled at a single center-175 in the D and 175 in the T groups. All @entity1 were followed until May 1998, with a mean follow-up of 33.8+/-9.1 months. Using an intention-to-treat analysis, the 1-, 2-, 3-, and 4-year @entity1 survival was 85.1%, 81.6%, 78.6%, and 75.8%, respectively, for D and 87.4%, 85.4%, 81.3%, and 79.9%, respectively, for T. The 4-year graft survival was 70% for D and 72.1% for T. Although the rate of acute rejection in the first 3 months was significantly lower for T than for D (28% for triple vs. 38.9% for double, P=0.03), the overall rate of rejection for T at the end of 1 year was not significantly lower than for the D (38.9% triple vs. 45.2% double). The median time to the first episode of rejection was 14 days for D versus 24 days for T (P=0.008). During the study period, 38 of 175 @entity1 in D received @entity2098 to control ongoing acute rejection, nephrotoxicity, and/or @entity2359 . On the other hand, 103 @entity1 in the T discontinued @entity2098 for infection, @entity344 . The need for corticosteroids was less after 6 months for T and the perioperative need for dialysis was lower with use of @entity2098 . CONCLUSION: This final report confirms similar @entity1 survival and graft survival up to 4 years with a trend towards fewer episodes of rejection, lower need for @entity230 , and better perioperative renal function. However, the complex nature of LTx @entity1 and their posttransplantation course prevents the routine application of @entity2098 .

A prospective randomized trial of @entity1140 and prednisone versus XXXX , prednisone and mycophenolate mofetil in primary adult liver transplantation: a single center report.

@entity230 :: ('MESH:D013256', 'Chemical') :: ['steroids'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity344 :: ('MESH:D005767', 'Disease') :: ['myelosuppression, and/or gastrointestinal disturbances'] @entity2098 :: ('CHEBI:8764', 'Chemical') :: ['MMF'] @entity1140 :: ('MESH:D016559', 'Chemical') :: ['Tacrolimus'] @entity11636 :: ('CHEBI:53498', 'Chemical') :: ['TAC'] @entity6051 :: ('CHEBI:168396', 'Chemical') :: ['mycophenolate'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity']
@entity1140 :: (MESH:D016559,Chemical) :: ['tacrolimus']
