Purpose: Results of the US randomized, comparative, multicenter study demonstrated that tacrolimus (Tac) was equivalent to cyclosporine (CyA) in 1-year patient and graft survival in recipients of cadaveric renal transplants. However, the incidence and severity of acute rejection was significantly lower in Tac-treated patients compared with CyA-treated patients. This retrospective, non-randomized single center study represents results of follow-up to 3 years posttransplant.
Methods: A total of 97 kidney transplant recipients were included; 41 received Tac-based immunosuppression, and 56 received CyA-based immunosuppression and followed for 3 years posttransplant. Serious adverse events were also monitored over 3 years.
Results: The three-year patient survival rates were 95.0% and 96.5% for Tac and CyA, respectively (P=NS). Corresponding graft survival rates were 90.2% and 91.0%, respectively (P=NS). However, the incidence of acute rejection was significantly less in the Tac-group compared with the CyA-group (17.1% vs. 35.7%, P=0.043). The rate of crossover was significantly higher in the CyA-group (4.9% vs. 21.4%, P=0.013). Renal function at 3 years was similar in both treatment groups. The incidence of posttransplant diabetes mellitus (PTDM), head-ache and alopecia was significantly less in the CyA-group, and that of hypertension, hypercholesterolemia after transplantation was significantly less in Tac-group. The incidence of hirsutism and gingival hyperplasia was negligible in Tac-group. Incidence of hand tremor, hyperkalemia, bacterial and viral infection, and malignancy was comparable in both groups. The incidence of PTDM was significantly less in CyA-group (26.8% vs. 7.1%, P=0.008). Nine (81.8%) of the 11 Tac patients with PTDM were off of insulin at 3 years.
Conclusion: Tacrolimus is a very effective primary immunosuppressive agent in renal transplant recipient. The reduced incidence of acute rejection along with decreased incidence of hypertension and hyperlipidemia after transplantation suggests potential long-term advantage with the use of this drug.
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