Cyclosporine Lowering with Everolimus versus Mycophenolate Mofetil in Heart Transplant Recipients: Long-term Follow-up of the SHIRAKISS Randomized, Prospective Study.
Potena L, Prestinenzi P, et al.Journal of Heart & Lung Transplantation, 31(6):565-70, 2012.
Aims
Aim: To evaluate the long term efficacy comparing cyclosporine lowering in combination with mycophenolate mofetil (MMF) to everolimus in heart transplant recipients.
Interventions
Everolimus with a very low dose of cyclosporine (C0: 50 to 90 ng/ml) versus MMF with low dose of cyclosporine (C0: 100 to 150 ng/ml).
Participants
34 recipients with renal dysfunction 1 to 4 years posttransplant.
Outcomes
Creatinine clearance, 24 hour urinary protein excretion, cellular rejection confirmed by endomyocardial biopsy, serum creatinine, cyclosporine through levels and lipid profile. Safety outcomes included rate of infections, cardiovascular events and neoplasms, new-onset malignancies and hyperlipemia.
Follow-up
3 years
CET Conclusions
This under powered study in patients with renal dysfunction following heart transplantation suggested that cyclosporine nephrotoxicity improved with a dose reduction both with patients receiving MMF or everolimus. However patients with baseline proteinuria receiving everolimus showed deterioration in renal function.
Data analysis
Available case analysis
Trial registration
NCT00420537 (ClinicalTrials.gov)