INTRODUCTION:Sirolimus is the one of new immunosuppressants that may be a substitute to traditional drugs such as cyclosporine. We present our investigation on sirolimus-based immunosuppression in kidney transplant recipients as compared with cyclosporine-based immunosuppression. MATERIALS AND METHODS: We enrolled 100 patients in an open-labeled randomized clinical trial at Shahid Labbafinejad Medical Center. The patients were assigned to one of the immunosuppressive groups to receive either sirolimus or cyclosporine in combination with mycophenolate mofetil and steroids. All kidney transplant recipients were followed up by for serum creatinine and glomerular filtration rate for 4 years. RESULTS: There was no significant differences between the two groups regarding serum creatinine level and GFR until for years posttransplant; however, serum creatinine levels were significantly lower and the GFRs were higher in the sirolimus group after 3 and 4 years. The mean serum creatinine was 1.24 ± 0.28 mg/dL in the sirolimus group and 1.57 ± 0.33 mg/dL in the cyclosporine group at 4 years posttransplant (P = .02). Also, GFR was 79.8 ± 22.3 mL/min/1.73 m2 in the sirolimus group and 70.3 ± 23.6 mL/min/1.73 m2 in the cyclosporine group B (P = .04). Acute rejection was 1.7-fold higher in the cyclosporine group than in the sirolimus group. CONCLUSIONS: Our study demonstrated that sirolimus in the immunosuppressive regimen of kidney transplant recipients had better outcomes regarding graft and patient survival. The effectiveness of sirolimus for kidney allograft recipients should be further assessed to be implemented from the first day after transplantation.
RCT Entities:
INTRODUCTION:Sirolimus is the one of new immunosuppressants that may be a substitute to traditional drugs such as cyclosporine. We present our investigation on sirolimus-based immunosuppression in kidney transplant recipients as compared with cyclosporine-based immunosuppression. MATERIALS AND METHODS: We enrolled 100 patients in an open-labeled randomized clinical trial at Shahid Labbafinejad Medical Center. The patients were assigned to one of the immunosuppressive groups to receive either sirolimus or cyclosporine in combination with mycophenolate mofetil and steroids. All kidney transplant recipients were followed up by for serum creatinine and glomerular filtration rate for 4 years. RESULTS: There was no significant differences between the two groups regarding serum creatinine level and GFR until for years posttransplant; however, serum creatinine levels were significantly lower and the GFRs were higher in the sirolimus group after 3 and 4 years. The mean serum creatinine was 1.24 ± 0.28 mg/dL in the sirolimus group and 1.57 ± 0.33 mg/dL in the cyclosporine group at 4 years posttransplant (P = .02). Also, GFR was 79.8 ± 22.3 mL/min/1.73 m2 in the sirolimus group and 70.3 ± 23.6 mL/min/1.73 m2 in the cyclosporine group B (P = .04). Acute rejection was 1.7-fold higher in the cyclosporine group than in the sirolimus group. CONCLUSIONS: Our study demonstrated that sirolimus in the immunosuppressive regimen of kidney transplant recipients had better outcomes regarding graft and patient survival. The effectiveness of sirolimus for kidney allograft recipients should be further assessed to be implemented from the first day after transplantation.
Authors: Deirdre Hahn; Elisabeth M Hodson; Lorraine A Hamiwka; Vincent Ws Lee; Jeremy R Chapman; Jonathan C Craig; Angela C Webster Journal: Cochrane Database Syst Rev Date: 2019-12-16