title: Comparative long-term evaluation of tacrolimus and cyclosporine in pediatric liver transplantation.
abstract: BACKGROUND
  In this report, we compare the long-term outcome of pediatric liver transplantation (LTx) patients maintained with tacrolimus-based and with cyclosporine (CsA)-based immunosuppressive therapy. We examine long-term patient and graft survival, the incidence of rejection, and immunosuppression-related complications.
  
  
  METHODS
  There were 233 consecutive primary LTx in children (ages <18 years) performed between October 1989 and December 1994 with tacrolimus-based immunosuppressive therapy (Group I). These were compared with 120 consecutive primary LTx performed with CsA-based immunosuppressive therapy between January 1988 and October 1989(Group II). Children in both groups were followed until July 1999. Mean follow-up was 91.41+/-17.7 months (range 55.6-117.8) for Group I, and 128+/-6.1 months (range 116.7-138.6) for Group II.
  
  
  RESULTS
  At 9 years of follow-up, actuarial patient and graft survival were significantly improved (patient survival 85.41% in Group I vs. 63.8% in Group II, P=0.0001; graft survival Group I 78.9% vs. 60.8% Group II, P=0.0003) and the rate of re -transplantation was significantly lower among patients in Group I (12% in Group I vs. 22.5% in Group II P=0.01). Children in Group I also experienced a significantly reduced incidence of acute rejection (0.97 per patient Group I vs. 1.5 per patient Group II P=0.002) and significantly less steroid resistant acute rejection episodes (3.1% in Group I vs. 8.6% in Group II P=0.0001). The mean steroid dose was significantly lower in Group I compared with Group II at all time points (P=0.0001) after LTx. Freedom from steroid was also significantly higher in Group I compared with Group II at all time points after LTx (ranging from 78% to 84% in Group I and 9% to 32% in Group II during a 1- to 7-year posttransplant period P=0.0001). The rate of hypertension was significantly lower in Group I than Group II (P=0.0001), and the severity of hypertension (need for more than one anti-hypertensive medication) was also significantly lower in Group I than Group II (P=0.0001). Although the rate of posttransplant lymphoproliferative disorder (PTLD) was not significantly different (13.7% Group I vs.8.3% Group II, P=0.13), the survival after PTLD was significantly better for Group I at 81.2% than for Group II at 50% after 5 years (P=0.034). Conclusion. The results suggest that tacrolimus-based therapy provides significant long-term benefit to pediatric LTx patients, evidenced by significantly improved patient and graft survival, reduced rate of rejection, and hypertension with lower steroid doses.
authors.affiliation: Thomas E. Starzl Transplantation Institute, Children's Hospital, University of Pittsburgh, PA 15213, USA.
authors.forename: A
authors.initials: A
authors.lastname: Jain
authors.forename: G
authors.initials: G
authors.lastname: Mazariegos
authors.forename: R
authors.initials: R
authors.lastname: Kashyap
authors.forename: M
authors.initials: M
authors.lastname: Green
authors.forename: C
authors.initials: C
authors.lastname: Gronsky
authors.forename: T E
authors.initials: TE
authors.lastname: Starzl
authors.forename: J
authors.initials: J
authors.lastname: Fung
authors.forename: J
authors.initials: J
authors.lastname: Reyes
mesh_terms: D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016031:Liver Transplantation / Q000276:immunology / Q000401:mortality / Q000502:physiology*; D011241:Prednisone / Q000627:therapeutic use; D012086:Reoperation / Q000706:statistics & numerical data; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D011241:Prednisone; D016559:Tacrolimus