Fm. Senel et al., COMPARISON OF NEORAL AND SANDIMMUN FOR INDUCTION AND MAINTENANCE IMMUNOSUPPRESSION AFTER KIDNEY-TRANSPLANTATION, Transplant international, 10(5), 1997, pp. 357-361
We compared the mean trough level/dose (LID) ratio, mean coefficient o
f variation (CV) of individual patients, and graft, patient, and rejec
tion-free survival rates of 40 renal transplant recipients receiving N
eoral (CyE) with 103 consecutive renal transplant recipients receiving
Sandimmun (CyA). The mean L/D ratio on the 3rd posttransplant day (16
.2 vs 11.8, P < 0.04), in the Ist week (24.6 vs 16.1; P < 0.03), and 1
st month (39.1 vs 28.7; P < 0.05) were higher in the CyE group. In bot
h groups the L/D ratio improved in proportion to the duration of time
post-transplant and reached a maximum in the 3rd posttransplant month.
In the early post transplant period in particular, the number of pati
ents achieving target levels was significantly higher, and the mean do
se needed to achieve target levels lower, in the CyE group. The variat
ion in trough levels, demonstrated by the CV, was lower in the CyE gro
up (0.41 +/- 0.14) than in the CyA group (0.62 +/- 0.21; P < 0.005). A
ctuarial 1-year patient and graft survival rates in the CyE group were
100 % and 96 %, respectively; these were similar to the 100 % and 95
% in the CyA group. The 1-year rejection-free survival rate in the CyE
group was 61% compared to 43 % in the CyA group (P < 0.02). We conclu
de that it is possible to obtain higher blood trough levels at lower d
oses by administering CyE, particularly in the early post-transplant p
eriod. The lower variability of trough levels and the higher LID ratio
in the CyE group, which are related to improved bioavailability of Cy
E, may explain the lower rejection rate among these patients. In this
study, the microemulsion formulation of cyclosporin (CyE) was found to
be more beneficial and cost-effective as induction and maintenance im
munosuppression than the conventional formulation (CyA).