91085
document
Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients . The Oral Ganciclovir International Transplantation Study Group [ corrected ] . BACKGROUND Cytomegalovirus ( CMV ) disease is a frequent cause of serious morbidity after solid-organ transplantation . The prophylactic regimens used to prevent CMV infection and disease have shown limited benefit in seronegative recipients . We studied the safety and efficacy of oral ganciclovir in the prevention of CMV disease following orthotopic liver transplantation . METHODS Between December , 1993 , and April , 1995 , 304 liver-transplant recipients were randomised to receive oral ganciclovir 1000 mg or matching placebo three times a day . Seronegative recipients of seronegative livers were excluded . Study drug was administered as soon as the patient was able to take medication by mouth ( no later than day 10 ) until the 98th day after transplantation . Patients were assessed at specified times throughout the first 6 months after surgery for evidence of CMV infection , CMV disease , rejection , opportunistic infections , and possible drug toxicity . FINDINGS The Kaplan-Meier estimate of the 6-month incidence of CMV disease was 29 ( 18.9 % ) of 154 in the placebo group , compared with seven ( 4.8 % ) of 150 in the ganciclovir group ( p < 0.001 ) . In the high-risk group of seronegative recipients ( R- ) of seropositive livers ( D+ ) , incidence of CMV disease was 11 ( 44.0 % ) of 25 in the placebo group , three ( 14.8 % ) of 21 in the ganciclovir group ( p = 0.02 ) . Significant benefit was also observed in those receiving antibodies to lymphocytes , where the incidence of CMV disease was 12 ( 32.9 % ) of 37 in the placebo group and two ( 4.6 % ) of 44 in the ganciclovir group ( p = 0.002 ) . Oral ganciclovir reduced the incidence of CMV infection ( placebo 79 [ 51.5 % ] of 154 ; ganciclovir 37 [ 24.5 % ] of 150 ; p < 0.001 ) and also reduced symptomatic herpes-simplex infections ( Kaplan-Meier estimates : placebo 36 [ 23.5 % ] of 154 ; ganciclovir five [ 3.5 % ] of 150 ; p < 0.001 ) . INTERPRETATION Oral ganciclovir is a safe and effective method for the prevention of CMV disease after orthotopic liver transplantation .
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Intervention_Pharmacological
oral ganciclovir
91087
Intervention_Pharmacological
Ganciclovir
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Intervention_Pharmacological
oral ganciclovir
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Intervention_Pharmacological
oral ganciclovir 1000
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Intervention_Control
placebo
91091
Intervention_Pharmacological
ganciclovir
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Intervention_Control
placebo
91093
Intervention_Pharmacological
ganciclovir
91094
Intervention_Control
placebo
91095
Intervention_Pharmacological
ganciclovir
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Intervention_Control
placebo
91097
Intervention_Pharmacological
ganciclovir
91098
Intervention_Control
placebo
91099
Intervention_Pharmacological
ganciclovir
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Outcome_Physical
efficacy and safety
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Outcome_Physical
safety and efficacy
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Outcome_Other
CMV infection , CMV disease , rejection , opportunistic infections , and possible drug toxicity .
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Outcome_Other
6-month incidence of CMV disease
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Outcome_Other
incidence of CMV disease
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Outcome_Other
CMV disease
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Outcome_Other
incidence of CMV infection
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Outcome_Other
symptomatic herpes-simplex infections
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Participant_Condition
liver-transplant
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Participant_Sample-size
304
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Participant_Condition
seronegative livers
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Participant_Condition
liver transplantation