Irish WD, Sherrill EH, Brennan DC, Lowell J, Schnitzler M. 3-year renal graft survival using tacrolimus versus cyclosporine microemulsion, in combination with mycophenolate mofetil and steroids. Poster presented at the World Congress of Nephrology; 2003.

BACKGROUND: No clinical study has reported a significant difference in graft or patient survival following renal transplantation between tacrolimus and the microemulsion formulation of cyclosporine, Neoral. We investigated a large cohort of patients registered in the US Renal Data System receiving tacrolimus or Neoral with mycophenolate mofetil and steroids for differences in 3-year graft survival between the regimens.

METHODS: Adult patients receiving a first renal allograft during the period January 1995 - December 1998 who had a functioning graft at six months were categorized by intent-to-treat primary immunosuppression. Unadjusted Kaplan-Meier analysis estimated graft failure rate including and excluding death. Due to the observational nature of the data, relative hazard rates were generated using Cox proportional hazards regression analysis with stratification on transplant year and adjustment for demographic and clinical characteristics.

RESULTS: 9,449 patients were included in the analysis (cadaveric donor, n=6,011; living donor, n=3,438). 7,319 received Neoral-based immunosuppression and 2,130 received tacrolimus-based immunosuppression . At three years post-transplant, the proportion of cadaveric donor recipients experiencing all-cause graft loss was 10.6% for Neoral and 10.0% for tacrolimus; for living donor recipients these figures were 6.7% and 6.5%, respectively. The incidence of graft failure excluding death was also similar between the two treatment groups. For cadaveric donor recipients, the adjusted relative hazard ratio for failure for patients on tacrolimus versus Neoral was 1.02 (95% CI 0.8-1.3) and for living donor recipients was 1.15 (95% CI 0.8-1.8). The proportion of grafts lost due to chronic allograft nephropathy was similar in both groups.

CONCLUSIONS: This registry analysis of almost 9,500 patients found no evidence of a significant difference in all-cause graft failure, or in graft failure excluding death, between tacrolimus- and Neoral-based immunosuppression in conjunction with mycophenolate mofetil and steroids. Since treatment groups were non-randomized, multivariable regression techniques were utilized as a means to reduce treatment selection bias. Based on these results, relative cost-effectiveness may become increasingly important in selection of tacrolimus or Neoral as primary immunosuppressant.

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