Efficacy and Safety of Low-Dose Versus Standard-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Intermediate-Risk Kidney Transplant Recipients.
Halim MA, Al-Otaibi T, et al.Experimental & Clinical Transplantation 2016 [record in progress].
Aims
To evaluate the efficacy and safety of two different doses of valganciclovir prophylaxis for cytomegalovirus (CMV) infection after kidney transplant.
Interventions
Participants were randomized to receive either prophylaxis with low-dose (450 mg/d) versus highdose (900 mg/d) valganciclovir for the first 6 months after transplant.
Participants
201 kidney transplant recipients aged > 18 years who could tolerate oral valganciclovir within 1 week posttransplant.
Outcomes
The primary outcome measured was the proportion of patients who developed CMV disease up to 1 year posttransplant. Other outcomes measured included early-onset and late-onset CMV disease, number and consequences of leukopenia attacks, associated infections, rejection episodes, and graft and patient outcomes.
Follow-up
12 months
CET Conclusions
This study aimed to compare low-dose and standard-dose valganciclovir for CMV prophylaxis in intermediate-risk kidney transplant recipients. The primary outcome for the study is supposedly the proportion of patients who developed CMV disease up to one year after renal transplant. However the power calculation does not seem to fit with this type of outcome. The rates of CMV disease are also so low overall that a study of this size could not have been powered for this outcome. There was a very good degree of follow up reported and the study seems to show that there was no difference in CMV disease although leukopenia was reduced with lower-dose valganciclovir. Leukopenia was not defined by a specific value, but rather episodes that required manipulation of the study medication or immunosuppressive drugs.
Data analysis
Modified intention-to-treat analysis
Trial registration
None