31116
document
Tacrolimus monotherapy without steroids after liver transplantation -- a prospective randomized double-blinded placebo-controlled trial . Early steroid withdrawal after liver transplantation ( LT ) is desirable in order to reduce steroid side effects . Between February 2000 and August 2004 , 110 patients after LT were included in this prospective , randomized , double-blind , placebo-controlled trial . Randomization was performed before LT . In all patients , tacrolimus was used without induction therapy . All patients received methylprednisolon for 14 days , thereafter a double-blinded medication containing either placebo ( n = 56 ) or methylprednisolon ( n = 54 ) for 6 months , which was completely stopped thereafter . End points were patient and graft survival , acute and chronic rejection , and incidence of steroid side effects during the first year after LT . One-year patient survival was 85.7 % ( placebo ) and 88.8 % ( steroid ) ( p = 0.572 ) . Twenty-seven ( 48.2 % ) and 19 ( 35.2 % ) patients experienced acute rejection ( placebo versus steroid , respectively ; p = 0.116 ) . Two patients in the placebo group but none in the steroid group experienced chronic rejection ( p = 0.257 ) . The rates of side effects were ( placebo versus steroid , respectively ) : CMV infection 25 % versus 33 % ( p = 0.336 ) , post-transplant diabetes 30 % versus 53 % ( p = 0.024 ) , hypertension 39 % versus 52 % ( p = 0.248 ) , hypercholesterolemia 10 % versus 41 % ( p = 0.002 ) and hypertriglyceridemia 32 % versus 54 % ( p = 0.046 ) . In conclusion , early steroid withdrawal after LT is feasible under tacrolimus monotherapy without increased rejection rates and with a lower rate of side effects .
31117
Intervention_Pharmacological
Tacrolimus
31118
Intervention_Control
placebo-controlled
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Intervention_Pharmacological
tacrolimus was used without induction therapy
31120
Intervention_Pharmacological
methylprednisolon
31121
Intervention_Control
placebo
31122
Intervention_Pharmacological
methylprednisolon
31123
Intervention_Control
placebo
31124
Intervention_Pharmacological
steroid
31125
Intervention_Pharmacological
tacrolimus
31126
Outcome_Mortality
patient and graft survival
31127
Outcome_Physical
acute and chronic rejection
31128
Outcome_Adverse-effects
incidence of steroid side effects
31129
Outcome_Mortality
patient survival
31130
Outcome_Physical
acute rejection
31131
Outcome_Physical
chronic rejection
31132
Outcome_Adverse-effects
rates of side effects
31133
Outcome_Physical
CMV infection
31134
Outcome_Physical
post-transplant diabetes
31135
Outcome_Physical
hypertension
31136
Outcome_Physical
hypercholesterolemia
31137
Outcome_Physical
hypertriglyceridemia
31138
Outcome_Other
feasible
31139
Outcome_Adverse-effects
lower
31140
Outcome_Physical
rate of side effects
31141
Participant_Condition
liver transplantation
31142
Participant_Condition
liver transplantation ( LT )
31143
Participant_Sample-size
110
31144
Participant_Condition
after LT
31145
Participant_Condition
LT