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Randomized Controlled Trial
. 2010 Aug 27;90(4):412-8.
doi: 10.1097/TP.0b013e3181e81afc.

Impact of prophylactic versus preemptive valganciclovir on long-term renal allograft outcomes

Michael L Spinner  1 , Georges Saab, Ed Casabar, Lyndsey J Bowman, Gregory A Storch, Daniel C Brennan
Affiliations
Randomized Controlled Trial

Impact of prophylactic versus preemptive valganciclovir on long-term renal allograft outcomes

Michael L Spinner et al. Transplantation. .

Abstract

Background: Both prophylactic and preemptive oral valganciclovir therapy are effective for the management of cytomegalovirus (CMV) postrenal transplantation in the short term. The long-term effect of either strategy is less well defined.

Methods: We analyzed the data on 115 adult recipients previously enrolled in a prospective randomized controlled trial of prophylaxis versus preemptive therapy for CMV. The primary outcome was a composite of freedom from acute rejection, graft loss, or death. Secondary outcomes included individual primary outcomes, posttransplant cardiovascular events, new-onset diabetes mellitus after transplantation, achievement of goal blood pressure, change in body mass index, interstitial fibrosis/tubular atrophy, and change in renal function. The analysis period was a minimum of 48-month posttransplant or a date of death or graft loss, whichever was earlier.

Results: The primary outcome was similar between groups (83% prophylactic vs. 81% preemptive, P=0.754). The secondary outcomes showed similarities between the prophylactic and preemptive groups. Four patients in the prophylactic group (8%) compared with none in the preemptive group (0%) died with a functioning graft, P=0.043.

Conclusions: Within the limitations of sample size, our data suggest that either strategy for the management of CMV immediately after transplantation seems effective for patient and graft survival in the long term. CMV management is one of the many therapeutic strategies incorporated into a renal transplantation protocol, which often differs among institutions, and the decision as to which approach to use remains center- and resource-specific. The increased incidence of death in the prophylactic group requires further investigation.

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Conflict of interest statement

Conflict of Interest Statement: The authors have no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier curves indicating proportion of patients meeting composite endpoint (A) death censored graft survival (B) and patient survival (C) in months post-transplantation.
Figure 2
Figure 2
Study population flowchart
See this image and copyright information in PMC

Comment in

References

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