AIM:To study the long-term outcome of ketoconazole and tacrolimus combination in kidney transplant recipients.METHODS:From 2006 to 2010,ketoconazole was given in 199 patients and was continued for at least 1year or until graft failure(Group 1),while 149 patients did not receive any ketoconazole(Group 2).A combination of tacrolimus,mycophenolate and steroid was used as maintenance therapy.High risk patients received basiliximab induction.RESULTS:Basic demographic data was similar between the 2 groups.The 5-year cumulative incidence of biopsy-confirmed and clinically-treated acute rejection was significantly higher in Group 1 than in Group 2(34%vs 18%,P=0.01).The 5-year Kaplan-Meier estimated graft survival(74.3%vs 76.4%,P=0.58)and patient survival(87.8%vs 87.5%,P=0.93)were not differentbetween the 2 groups.Multivariable analyses identified ketoconazole usage as an independent risk of acute rejection(HR=2.33,95%CI:1.33-4.07;P=0.003)while tacrolimus dose in the 2nd month was protective(HR=0.89,95%CI:0.75-0.96;P=0.041).CONCLUSION:Co-administration of ketoconazole and tacrolimus is associated with significantly higher incidence of acute rejection in kidney transplant recipients.
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