June 21, 2013

Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial.


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This multicenter trial randomized de novo heart transplant recipients to everolimus 1.5 mg or 3.0 mg with reduced-dose cyclosporine, or mycophenolate mofetil (MMF) 3 g/day with standard-dose cyclosporine (plus corticosteroids ± induction). Primary efficacy endpoint was the 12-month composite incidence of biopsy-proven acute rejection, acute rejection associated with hemodynamic compromise, graft loss/retransplant, death or loss to follow-up. The everolimus 3.0 mg arm was terminated early due to increased mortality. The study also concluded rATG induction with concurrent administration of everolimus with cyclosporine appears inadvisable due to a high rate of early infection-related deaths and should be avoided. Everolimus 1.5 mg with reduced-dose cyclosporine offered similar efficacy to MMF with standard-dose cyclosporine and reduced intimal proliferation at 12 months in de novo heart transplant recipients.

Cardiac Transplantation

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