Title: Lower incidence of cytomegalovirus infection with everolimus versus mycophenolate mofetil in de novo cardiac transplant recipients: a randomized, multicenter study
Authors: Vigano, M ×
Dengler, T
Mattei, MF
Poncelet, A
Vanhaecke, Johan
Vermes, E
Kleinloog, R
Gezahegen, Y
Delgado, JF #
Issue Date: Feb-2010
Publisher: Wiley-Blackwell Publishing, Inc.
Series Title: Transplant Infectious Disease vol:12 issue:1 pages:23-30
Abstract: Cytomegalovirus (CMV) is a major cause of infectious complications following cardiac transplantation, severely affecting short- and long-term outcomes. A 12-month, multicenter, randomized, open-label study in de novo cardiac transplant patients was undertaken to compare the efficacy, renal function, and safety of everolimus plus reduced cyclosporine versus mycophenolate mofetil (MMF) plus standard cyclosporine ( NCT00150046). CMV-specific data was prospectively collected on infections, laboratory evidence, CMV syndrome, and CMV disease. In total, 176 patients were randomized (everolimus 92; MMF 84). Use of CMV prophylaxis was similar between groups (everolimus 20.8%; MMF 24.0%). Patients in the everolimus arm had a significantly lower incidence of any CMV event (8.8% versus 32.5% with MMF, P < 0.001), CMV infection as an adverse event (4.4% versus 16.9%, P = 0.011), laboratory evidence of CMV (antigenemia 7.7% versus 27.7%, P < 0.001; polymerase chain reaction assay 2.2% versus 12.0%, P = 0.015), and CMV syndrome (1.1% versus 8.4%, P = 0.028). In the donor (D) + /recipient (R) + and D - /R + subgroups, even after adjusting for use of prophylaxis, the CMV event rate remained significantly lower with everolimus than with MMF (P = 0.0015 and P = 0.0381, respectively). In conclusion, de novo cardiac transplant recipients experienced lower rates of CMV infection, CMV syndrome, or organ involvement on an everolimus-based immunosuppressant regimen compared with MMF.
ISSN: 1398-2273
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Cardiology
× corresponding author
# (joint) last author

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