COMPARATIVE LONG-TERM EVALUATION OF TACROLIMUS AND CYCLOSPORINE IN PEDIATRIC LIVER TRANSPLANTATION

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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.

Method.

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 85.4% 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).

Results.

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).

Results.

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.

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