Comparison of the Tolerability and Safety of Microemulsion Cyclosporine Versus Conventional Cyclosporine in Primary Living-Related Renal Allograft Recipients

Jung, In Mok; Ahn, Moon Sang; Min, Seung Kee; Ahn, Curie; Ha, Jongwon; Kim, Sang Joon

Abstract

A microemulsion formulation of cyclosporine (CsE) is more bioavailable than conventional cyclosporine (CsA) in renal transplants. Because the risk of acute and chronic rejection is related inversely to cyclosporine bioavalability and cyclosporine has a low therapeutic window, these benefits of CsE with an improved pharmacokinetic profile on clinical efficacy are also of interest. To assess the long-term safety and tolerability of CsE, this comparable study was performed. One hundred thirty one primary living donor renal recipients were included in this study. They were divided two groups in the CsE group (N=50) and CsA group (N=81) who had been received either CsE or CsA as a main immunosuppressant since their transplantation for two years. There were no differences between two groups in initial dose at that time of transplantation, target trough level, strategies of anti-rejection therapy. Acute rejections occurred less frequently in CsE group than CsA group (9/50 vs. 28/81, p=0.041). No significant differences were noted in incidence of chronic rejection, graft loss, drug-associated com plications such as hypertension, diabetes mellitus, infection and survival rates of grafts and patients. Renal function, as measured by serum creatinine levels was comparable over time in both groups. The mean daily doses of CsE were higher than CsA group since post-transplant six months, but, no significant differences in trough levels between the two grups. There were marked decreases in standard deviation of daily doses and trough level those meant inter-individual variations in CsE group compared to those of CsA group. In conclusion, despite the more predictable and stabilized pharmacokinetic benefits in CsE group, no significant increases in the incidence of drug-associated adverse effects were observed within post-transplant two years. The safety, tolerability, efficacy of CsE and CsA were comparable.