45788
document
Early withdrawal of calcineurin inhibitors and everolimus monotherapy in de novo liver transplant recipients preserves renal function . We designed a randomized trial to assess whether the early withdrawal of cyclosporine ( CsA ) followed by the initiation of everolimus ( Evr ) monotherapy in de novo liver transplantation ( LT ) patients would result in superior renal function compared to a CsA-based immunosuppression protocol . All patients were treated with CsA for the first 10 days and then randomized to receive Evr in combination with CsA up to day 30 , then either continued on Evr monotherapy ( Evr group ) or maintained on CsA with/without mycophenolate mofetil ( CsA group ) in case of chronic kidney disease ( CKD ) . Seventy-eight patients were randomized ( Evr n = 52 ; CsA n = 26 ) . The 1-year freedom from efficacy failure in Evr group was 75 % versus 69.2 % in CsA group , p = 0.36 . There was no statistically significant difference in patient survival between the two groups . Mean modification of diet in renal disease ( MDRD ) was significantly better in the Evr group at 12 months ( 87.7 ± 26.1 vs. 59.9 ± 12.6 mL/min ; p < 0.001 ) . The incidence of CKD stage ≥ 3 ( estimated glomerular filtration rate < 60 mL/min ) was higher in the CsA group at 1 year ( 52.2 % vs. 15.4 % , p = 0.005 ) . The results indicate that early withdrawal of CsA followed by Evr monotherapy in de novo LT patients is associated with an improvement in renal function , with a similar incidence of rejection and major complications .
45789
Intervention_Pharmacological
calcineurin inhibitors
45790
Intervention_Pharmacological
everolimus monotherapy
45791
Intervention_Pharmacological
cyclosporine ( CsA )
45792
Intervention_Pharmacological
everolimus ( Evr ) monotherapy
45793
Intervention_Pharmacological
CsA
45794
Intervention_Pharmacological
with CsA
45795
Intervention_Control
Evr monotherapy ( Evr group )
45796
Intervention_Pharmacological
CsA
45797
Intervention_Pharmacological
mycophenolate mofetil
45798
Intervention_Pharmacological
Evr
45799
Intervention_Pharmacological
CsA
45800
Intervention_Pharmacological
Evr
45801
Outcome_Other
1-year freedom from efficacy failure
45802
Outcome_Mortality
patient survival
45803
Outcome_Physical
Mean modification of diet in renal disease ( MDRD )
45804
Participant_Condition
liver transplant
45805
Participant_Condition
de novo liver transplantation ( LT )
45806
Participant_Sample-size
Seventy-eight