Ponticelli C, Civati G, Tarantino A, et al.
Randomized study of cyclosporin in kidney
transplantation: a 10-year follow up
J Am Soc Nephrol
(May) 7:792-797 1996
The objective of this study was to compare the efficacy and toxicity after 10
years of treatment
with cyclosporin vs. azathioprine in cadaveric renal transplantation.
108 cadaveric transplant recipients were randomized to receive
cyclosporin (n=55) or azathioprine (n=53) both in combination with steroids.
The initial azathioprine dose was 3 mg/kg/d and then adjusted to keep WBC
count more than 5,000/mm3. Cyclosporin was given at 5 mg/kg IV followed by
15 mg/kg/d p.o.
with gradual dosage reductions every 2 weeks. The maintenance dose was then
adjusted to keep blood levels of 100-200 ng/ml (monoconal assay).
Cyclosporin toxicity was diagnosed by fine-needle biopsy. Statistical
analysis was intention-to-treat.
Ten year patient survival was 89% in cyclosporin group and 83% in
azathioprine group (pNS). 10-year graft survivals were 56% and 35%,
respectively (p=0.009). The rate of early rejection was significantly lower
in the cyclosporin group. After 1 year, there was no difference in half-
of functioning grafts, and the decline in graft function after 1 year was
similar in the two groups. There were trends for increased cataracts in the
cyclosporin group and increased cardiovascular events in the azathioprine
group. The conclusion of the study was, that cyclosporin is associated with
better long-term graft
survival than azathioprine with no increase in toxicity.
Comment: This is a well-done study with important clinical results.
improvement in long-term graft survival with cyclosporin can be attributed
less graft loss during the first year. Some clinicians substitute
azathioprine for cyclosporin after the first year in the hope of preventing
chronic cyclosporin toxicity and graft loss. These data, as well as those
the Collaborative Transplant Study, do not support this practice.
(David J. Leehey, M.D., Loyola University at Chicago)