Tacrolimus and Cyclosporine Have Differential Effects on the Risk of Development of Bronchiolitis Obliterans Syndrome: Results of a Prospective, Randomized International Trial in Lung Transplantation.
Treede H, Glanville AR, et al.Journal of Heart & Lung Transplantation, 31(8):797-804, 2012.
Aims
To assess the efficacy and safety of two de novo immunosuppression protocols in preventing Bronchiolitis Obliterans Syndrome (BOS) in lung transplantation.
Interventions
De novo tacrolimus versus cyclosporine. All patients were given mycophenolate mofetil and prednisolone after lung transplantation.
Participants
265 lung transplantation recipients.
Outcomes
The primary outcome was cumulative incidence of BOS at 3 years post-transplantation. Secondary outcomes included 1- and 3-year rates of acute allograft rejection, patient and graft survival, infections, adverse events and treatment failure.
Follow-up
3 years
CET Conclusions
In this large multicentre trial from experienced lung transplant units, tacrolimus was compared with cyclosporine although many patients on cyclosporine were converted to tacrolimus. The modified intention to treat analysis did suggest that the cumulative incidence of bronchiolitis obliterans was less in patients who received tacrolimus rather than cyclosporine. There was no difference in patient survival at 1 and 3 years and there was no difference in the incidence of adverse events.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT01429844 (ClinicalTrials.gov)