Tacrolimus: The good, the bad, and the ugly

The aim of this study was to evaluate the efficacy and side-effects of tacr olimus in pediatric transplant patients previously receiving cyclosporin A (CsA). This study was a retrospective chart review strengthened by a concom itant patient interview. Eleven pediatric cardiac or renal transplant patie nts, who had been converted from CsA to tacrolimus from October 1995 to Jan uary 1999 at The Cleveland Clinic Foundation, were included; there were six renal and five cardiac transplant patients. Each chart was reviewed to ass ess transplanted organ function pre- and post-conversion. For the six renal transplant patients, creatinine levels and biopsy findings were evaluated. For the five cardiac transplant patients, cardiac catheterization and rout ine biopsy data were analyzed likewise. Epstein-Barr virus (EBV) status was also evaluated in each patient. In addition, each parent or patient was in terviewed to ascertain dates of transplant, current medications, and side-e ffects. The patients' ages ranged from 6 to 20 yr (mean age 14.6 yr). All p atients had been converted to tacrolimus. Eight patients were converted for treatment of refractory rejection, two were converted because of CsA-assoc iated side-effects, and one patient was converted empirically for a history of multiple previous transplant rejections. Seven out of eight patients wh o received tacrolimus for rejection therapy improved. One patient had compl ete resolution of gingival hyperplasia. Another patient who previously deve loped hemolytic uremic syndrome on CsA had no further evidence of hemolysis . Four patients were weaned off steroid therapy. Despite conversion: two re nal transplant patients progressed to chronic rejection. Five patients exhi bited no side-effects. Side-effects experienced included transient hypergly cemia in conjunction with steroid use, headaches, and tremors that subsided rapidly. Four of 11 patients developed post-transplant lymphoproliferative disease (PTLD). Fortunately, reducing the dose of tacrolimus and/or surgic al resection of the mass (if present), eradicated the disease. In conclusio n, conversion therapy successfully provides an alternate treatment for acut e rejection. It also enabled some patients to discontinue steroid therapy, maximizing growth potential. PTLD is a severe, potentially life-threatening complication that needs to be recognized and monitored closely. In conclus ion, tacrolimus has been shown to be a very effective agent for the treatme nt of refractory organ rejection, but must be used cautiously.