Tacrolimus as a rescue immunosuppressant after heart and lung transplantation. The U.S. Multicenter FK506 Study Group.

BACKGROUND: Organ transplant recipients with refractory rejection or intolerance to conventional immunosuppressants may respond to rescue therapy with tacrolimus.
METHODS: Tacrolimus was used as a rescue immunosuppressant for 16 heart and 15 lung recipients. Heart recipients were converted to tacrolimus therapy because of cyclosporine intolerance, acute rejection despite treatment with cyclosporine, or humoral rejection. Lung recipients were converted because of cyclosporine intolerance, chronic rejection, or acute rejection. All immunosuppressive medications except corticosteroids were discontinued before tacrolimus therapy was begun. Patients remained in the study until they were converted to commercial tacrolimus.
RESULTS: The duration of follow-up after conversion varied widely (heart recipients: 183+/-65 days; lung recipients: 169+/-86 days). For the heart recipients, patient and graft survivals were 100%. Twenty percent of recipients experienced no rejection episodes after conversion to tacrolimus; 60% experienced none or only one. For the lung recipients, patient survival was 67% and graft survival was 60%. Eighty percent of recipients experienced no rejections and 13% experienced one episode of rejection each. The remaining patient experienced two biopsy-confirmed episodes of rejection. Five lung patients died within the year and one patient required retransplantation. The most common adverse events were diarrhea, headache, abnormal kidney function, depression, dyspnea, nausea, and pneumonia.
CONCLUSIONS: Tacrolimus is an effective and safe immunosuppressant for the rescue of heart transplant patients. Lung transplant patients may receive more benefit if rescued earlier.