The Safety and Effectiveness of Microemulsion Cyclosporine in Renal Allograft Recipients: 1 Year Follow-Up Study

Park, Ki Il; Moon, Jang Il; Kim, Soon Il; Kim, Yu Seun

Abstract

A microemulsion cyclosporine(Me-CsA) was developed and became available with more predictable whole blood CsA concentration and minimal inter- and intra-personal variability in daily dosage of CsA. We prospectively performed this study to assess 1) the ability of Me-CsA maintaining the adequate predefined therapeutic level and 2)long-term safety and tolerability of Me-CsA in kidney transplant recipients. A total of 123 renal transplant patients were enrolled on the Me-CsA group, who have been on Me-CsA as an initial main immunosuppressant since their transplantation. This group of patients were compared to 200 renal transplant patients on conventional cyclosporine(Con-CsA) as a historical control group(Con-CsA group). There were no differences in the methods of operation, induction immunosuppression, the strategies of maintenance immunosuppression and anti-rejection therapy between these two groups. The clinical status and laboratory values were monitored at 1,3,6,9, and 12 months after the kidney transplantation. There were no statistical differences in acute rejection episodes, serum creatinine level, and graft failure and survival rate between Con-CsA and Me-CsA groups. In this study, we could demonstrate the significant fluctuation of the mean values of daily dosage and whole blood trough level and their standard deviations of cyclosporine in Con-CsA group compare to those of Me-CsA group. We also could demonstrate early stabilization of CsA blood trough level in patients using Me-CsA. These results mean that Me-CsA has less interpersonal variations than Con-CsA. In conclusion, Me-CsA has more predictable pharmacodynamic characteristics than Con-CsA and comparable tolerability and safety to Con-CsA with no additional side effects.