Combined mycophenolate mofetil and minimal dose calcineurin inhibitor therapy in liver transplant patients: clinical results of a prospective randomized study

Abstract

Background: Long-term complications of calcineurin inhibitor (CNI)-based immunosuppression after liver transplantation (LT) have a marked impact on patient morbidity and mortality.

Methods: In this prospective study, LT patients with renal dysfunction were randomized (2:1) to either receive mycophenolate mofetil (MMF) followed by stepwise reduction of CNI with defined minimal CNI trough levels (MMF group) or to continue their maintenance CNI dose (control group).

Results: In the MMF group (n = 60), renal function assessed by serum creatinine improved >10% in 67% of patients, was stable in 32%, and deteriorated >10% in 2% after 12 months compared with baseline values. Mean serum creatinine levels (+/-SD) significantly decreased from 1.86 +/- 0.43 to 1.55 +/- 0.38 mg/dL and the corresponding calculated glomerular filtration rate (cGFR) significantly increased from 39.9 +/- 10.1 to 49.2 +/- 11.9 mL/min over a 12-month follow-up period. Blood pressure and levels of liver enzymes significantly decreased, and no allograft rejection occurred. In the control group (n = 30), there were no significant changes in mean serum creatinine and cGFR (1.78 +/- 0.59 mg/dL at baseline vs 1.93 +/- 0.86 mg/dL at month 12, and 41.3 +/- 13.2 mL/min vs 38.7 +/- 11.2 mL/min, respectively), liver enzymes and blood pressure throughout the study.

Conclusions: Combined MMF and minimal dose CNI therapy after LT is safe, and improves kidney function and the cardiovascular risk profile.