Combined Mycophenolate Mofetil and Minimal Dose Calcineurin Inhibitor Therapy in Liver Transplant Patients: Clinical Results of a Prospective Randomized Study

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 mofetit (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 presssure 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.