ESOT 2013: LATE-BREAKING SESSION: Preserving renal function with prolonged-release tacrolimus-based immunosuppression in de novo liver transplantation: initial results from the DIAMOND study

by Pavel Trunečka, Prague, Czech Republic – Starting on a low dose of prolonged-release, once-daily tacrolimus after liver transplantation achieved better renal function and a significantly lower risk of acute rejection over 24 weeks than starting on a standard dose of once-daily tacrolimus, either immediately post-transplant or after a five-day delay. Dr Pavel Trunečka from Prague in the Czech Republic presented the results of the Advagraf Studied In Combination with Mycophenolate Mofetil and Basiliximab in Liver Transplantation (DIAMOND) study.

The aim of the DIAMOND study was to investigate whether the superior clinical benefit with once-daily tacrolimus observed in the RESPECT study was due to either the delayed initiation or the lower tacrolimus exposure. A total of 893 liver transplant recipients where included in the study and received either standard-dose once-daily tacrolimus (Arm 1), low-dose once-daily tacrolimus plus basiliximab (Arm 2), or standard-dose once-daily tacrolimus from Day 5 post-transplant plus basiliximab. The primary endpoint was renal function as assessed by the estimated glomerular filtration rate (eGFR) at Week 24.

At Week 24, patients in Arms 2 and 3 had significantly higher eGFR rates compared with Arm 1 (76.4 and 73.3 vs 67.4mL/min/1.73m²; p<0.001 and p<0.047, respectively). Renal function was preserved in all treatment arms. No significant differences were noted between the treatment arms with respect to graft or patient survival. A significantly greater proportion of patients in Arm 2 did not experience AR, compared with the other two arms (79.9%, 85.7% and 79.6% (Arm 2 vs 1: p=0.0249, Arm 2 vs 3: p=0.0192). Dr Trunečka concluded that whilst a low initial dose of once-daily tacrolimus achieves better renal function and lower AR rate than a standard dose initiated either immediately post-transplant or after a five-day delay, there is no advantage with delaying the initiation of standard-dose tacrolimus.