Everolimus is associated with a reduced incidence of cytomegalovirus infection following de novo cardiac transplantation.
Kobashigawa J, Ross H, et al.Transplant Infectious Disease [record in progress].
Aims
This was a pooled analysis of three randomised controlled trials (B253, A2403 and A2411). The aim of the analysis was to determine the incidence of cytomegalovirus (CMV) infection and CMV syndrome/disease associated with different everolimus regimens.
Interventions
In all three studies medication was administered to patients within 72 h post transplantation. In study B253, patients received fixed-dose everolimus (1.5 or 3 mg/day) or AZA (1–3 mg/kg/day, orally) together with standard-dose CsA microemulsion (CsA-ME) and corticosteroids. In A2403, patients received everolimus 1.5 mg/day (target trough blood levels 3–8 ng/mL) together with either full-dose or reduced-dose CsA–ME and corticosteroids. In A2411, patients were randomly assigned (1:1) to receive everolimus 1.5 mg/day (target trough blood levels 3–8 ng/ mL) together with reduced dose CsA-M
Participants
1009 heart transplant recipients
Outcomes
Occurrence of CMV infection as reported by the investigators, and the combined occurrence of CMV syndrome/disease. The impact of donor/recipient (D/R) CMV status and prophylaxis in the D/R serology subgroups was also analysed.
Follow-up
6 months
CET Conclusions
This analysis of data from 3 large randomised studies in cardiac transplantation comparing different everolimus regimens with azathioprine and mycophenolate based regimens suggested that everolimus was associated with a lower incidence of CMV infection compared with azathioprine and MMF regimens.
Quality notes
Quality assessment is not appropriate.
Trial registration
Clinicaltrials.gov - NCT00098007 and NCT00150046