11398
document
A randomized prospective controlled trial of oral ganciclovir versus oral valacyclovir for prophylaxis of cytomegalovirus disease after renal transplantation . Oral ganciclovir and valacyclovir reduce the incidence of cytomegalovirus ( CMV ) disease after renal transplantation ( RTx ) . Our study was designed to compare the efficacy , costs , and safety of oral ganciclovir and valacyclovir in the prophylaxis of CMV disease over the first 6 months after RTx . A total of 38 patients was randomized to 3-month treatment with either oral ganciclovir ( 1 g t.i.d. , n=14 , GAN group ) or oral valacyclovir ( 2 g q.i.d. , n=12 , VAL group ) . A third group ( C , n=12 ) received no prophylaxis . The patients were monitored by CMV-nested PCR in whole blood . No differences were found between the groups in their demographic characteristics , immunosuppressive protocols , or donor and recipient CMV serology . Thirty-six out of 38 ( 94.7 % ) recipients were CMV-seropositive . Over the 6-month post-RTx period , there were 13 episodes of CMV disease in eight ( 66.7 % ) patients of the C group compared with none in the GAN and VAL groups ( P=0.0005 , GAN vs C ; P=0.001 , VAL vs C ) . The incidence of CMV viremia was 30.8 % , 50.0 % , and 91.7 % in the GAN , VAL , and C groups , respectively ( P=0.004 , GAN vs C ; P=0.07 , VAL vs C ; P=NS , GAN vs VAL ) . Treatment failure ( death , graft loss , CMV disease , or withdrawal from study ) occurred in 14.3 % , 0 % and 66.7 % in the GAN , VAL , and C groups , respectively ( P=0.014 , GAN vs C ; P=0.001 , VAL vs C ; P=NS , GAN vs VAL ) . The average CMV-associated costs per patient ( in 2001 euros ) were 2,449+/-1,178 , 2,485+/-581 , and 4,259+/-4,616 in the GAN , VAL , and C groups , respectively . Ganciclovir and valacyclovir were well tolerated , with ganciclovir having had to be withdrawn shortly in one patient only because of thrombocytopenia . In conclusion , oral ganciclovir and valacyclovir are equally safe and effective in the prophylaxis of CMV disease after RTx . Both are cost-effective and help reduce CMV-associated costs by some 40 % compared with patients without prophylaxis .
11399
Intervention_Pharmacological
ganciclovir
11400
Intervention_Pharmacological
valacyclovir
11401
Intervention_Pharmacological
ganciclovir
11402
Intervention_Pharmacological
valacyclovir
11403
Intervention_Pharmacological
ganciclovir
11404
Intervention_Pharmacological
valacyclovir
11405
Intervention_Pharmacological
oral ganciclovir
11406
Intervention_Pharmacological
oral valacyclovir
11407
Intervention_Control
no prophylaxis
11408
Outcome_Physical
cytomegalovirus disease
11409
Outcome_Physical
cytomegalovirus ( CMV ) disease
11410
Outcome_Other
efficacy
11411
Outcome_Other
costs
11412
Outcome_Other
safety
11413
Outcome_Physical
CMV-seropositive .
11414
Outcome_Physical
CMV
11415
Outcome_Physical
incidence of CMV viremia
11416
Outcome_Mortality
death
11417
Outcome_Adverse-effects
graft loss
11418
Outcome_Physical
CMV disease
11419
Outcome_Other
withdrawal from study
11420
Outcome_Other
average CMV-associated costs per patient
11421
Outcome_Other
well tolerated
11422
Outcome_Other
equally safe and effective
11423
Outcome_Other
cost-effective
11424
Outcome_Other
CMV-associated costs
11425
Participant_Condition
renal transplantation .