Long-term Effect of Conversion from Conventional Cyclosporine to Microemulsion Cyclosporine in Renal Allograft Recipient: 1 year follow-up study

Kim, Myoung Soo; Kim, Soon Il; Koh, Seung Sang; Moon, Jang Il; Kim, Soo Hyon; Kim, Yu Seun; Park, Ki Il

Abstract

Recently a new formulation of CsA, based on microemulsion technology, has been developed and became available. This improved galenic technology allows more predictable and consistent absorption, thus minimizing inter-patient and intra-patient variability and permitting more predictable whole blood CsA concentration. The objectives of this study are to assess 1) long-term safety and tolerability in renal transplant patients when switched from conventional CsA(Con-CsA) to microemulsion CsA(Me-CsA), 2) the ability of Me-CsA to maintain CsA blood trough levels in the predefined therapeutic window, and 3) the long-term side effects of Me-CsA. A total number of 965 renal transplant patients had been surveyed. These patients had to have variable graft function under Con-CsA based immunosuppression and at least 1 month passed since their last graft. After a one month run-in phase, Con-CsA was converted to Me-CsA patients on a 1:1 dose level basis. The clinical status such as graft dysfunction, graft and patient survival, medical illness and side effects were monitored. The clinical laboratory studies such as CBC, BUN, creatinine, serum electrolyte, liver function test, blood cyclosporine trough level and 24hr urinary excretion of protein were monitored every 3 or 6 months for 1 year. The results of our research are as following; 1) During conversion period from Con-CsA to Me-CsA, there was no episode of Me-CsA related side effects and admission cases. 2) There were statistical differences in mean CsA blood level during Con-CsA period, but no significant distinctions were noted during Me-CsA period. 3) Daily dosages of the Con-CsA were statistically variable between one month interval periods, but the Me-CsA daily dosages were statistically stable between 3,6,9, and 12 months after the conversion. 4) Serum creatinine level did not change significantly by the conversion.