Clinical outcome of heart transplant recipients receiving tacrolimus with or without mycophenolate mofetil.
Tacrolimus (TAC) is a calcineurin inhibitor that is used for cardiac allograft rejection. Efficacy and safety data of a combined TAC/mycophenolate mofetil (MMF) therapy in comparison with a TAC/cortisone therapy in heart recipients are lacking. We analysed the clinical outcome of 41 patients who received TAC in combination with MMF (TMF group) and of 41 patients who received TAC in combination with cortisone (TCO group). Outcomes were serum creatinine levels, cardiac rejections, cytomegalovirus infections, graft vasculopathy, malignancy rates and two-yr survival. Baseline characteristics were comparable in the two study groups. During follow-up, serum creatinine levels decreased slightly in the TMF group (p=0.039) but not in the TCO group. Compared with the TMF group, more clinically proven cardiac rejections which needed a cortisone bolus and more severe rejections that needed lymphoablative therapy with OKT occurred in the TCO group (p=0.001 and 0.04, respectively). In contrast, significantly more cytomegalovirus (CMV) infections occurred in the TMF group compared with the TCO group (p=0.01). The number of patients with graft vasculopathy as well as malignancy rates and overall survival did not differ significantly between the two study groups. The introduction of MMF was associated with an improvement of renal function and a more efficient immunosuppressive therapy. However, this treatment strategy also had led to a higher CMV infection rate compared with cortisone. Consequently, no general recommendation can be given at present whether TAC should be combined with MMF or with cortisone in heart transplant recipients.