Microemulsion Cyclosporine (Sandimmun Neoral(R)) Post-marketing Surveillance in Renal Transplant Recipients (multi-center study in Korea)

Park, Kiil

Abstract

In Korea, 9,396 kidney transplantations were performed by 44 centers until the end of 1998. Fourteen major centers performed about 76% of kidney transplantations (7,123) and they participated in the post-marketing surveillance (PMS) program. Patients on cyclosporine (Sandimmun(R)or Sandimmun Neoral(R)) with functioning graft were enrolled for PMS study and the numbers were 4,544. Surveillance started at the time of conversion from conventional cyclosporine (c-CsA) to microemulsion cyclosporine (me-CsA) in 2,899 recipients (conversion group) or at any post-transplant (post-Tx) period in 1,645 recipients who had received me-CsA since their kidney transplantations (new group). The starting point of PMS (mean) was post-Tx 52.5 months in conversion group and 4.8 months in new group. During the follow-up period (25.1 10.5 months), 339 recipients (7.5%) discontinued me-CsA due to graft failure (n=179, 52.8%), patient death (n=72, 21.2%), conversion of main immunosuppressive agent (n=43, 12.7%) or follow-up loss (n=45, 13.3%). The graft survival rate of conversion and new group was 95.8% and 98.3% in post-PMS 12 months, respectively. The incidence of acute rejection was 25.4% within 1 year after transplantation in new group. The incidence of chronic rejection for post-PMS 1 year was 6.7% in conversion group and 1.2% in new group. During the study period, there were no significant interval changes of serum creatinine and BUN in recipients with functioning graft on both groups (P>0.05). In conversion group, there was a trend of daily CsA dose decrement, but this is not significant statistically. The incidence of metabolic or other complications in recipients was 13.5% and they were; hypertension (6.2%), cardiovascular accident (0.6%), cerebrovascular accident (0.2%), post-transplant diabetes (1.5%) and avascular necrosis (0.5%). Infectious complication occurred in 4.5% recipients and biopsy proven CsA toxicity was found in 1.5% of recipients. The incidence of patient with abnormal liver function test (more than twice of effects after conversion. There was an acceptable range of acute and chronic rejection, graft survival rate, CsA-related side effects and medical events in Korean renal transplant recipients in new transplant group.