Mycophenolate mofetil use is associated with prolonged graft survival after kidney transplantation (original) (raw)
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Journal of the American Society of Nephrology, 2007
The Mycophenolate Steroids Sparing (MYSS) study found that in renal transplant recipients who were on immunosuppressive therapy with the cyclosporine microemulsion Neoral, mycophenolate mofetil (MMF) was not better than azathioprine in preventing acute rejection at 21 mo after transplantation and was 15 times more expensive. The MYSS Follow-up Study, an extension of MYSS, was aimed at comparing long-term outcome of 248 MYSS patients according to their original randomization to MMF (1 g twice daily) or azathioprine (75 to 100 mg/d). Primary outcome was estimated GFR at 5 yr after transplantation. Mean 5-yr GFR difference between azathioprine and mycophenolate was 4.67 ml/min per 1.73 m 2 (95% confidence interval [CI] ؊0.43 to 9.77 ml/min per 1.73 m 2 ; P ؍ 0.07). GFR from month 6 (mean ؎ SEM: 54.3 ؎ 1.6 versus 53.9 ؎ 1.5 ml/min per 1.73 m 2 ; P ؍ 0.83) to month 72 after transplantation (49.5 ؎ 2.2 versus 47.3 ؎ 2.4 ml/min per 1.73 m 2 ; P ؍ 0.50); GFR slopes (mean ؎ SEM: ؊1.10 ؎ 0.56 versus ؊1.23 ؎ 0.31 ml/min per 1.73 m 2 per year; P ؍ 0.83); and 72-mo patient mortality (4.0 versus 4.0% [P ؍ 0.95]; HR 0.96; 95% CI 0.28 to 3.31; P ؍ 0.95), graft loss (6.8 versus 6.1% [P ؍ 0.82]; HR 0.89; 95% CI 0.32 to 2.46; P ؍ 0.83), incidence of persistent proteinuria (25.0 versus 27.4%; P ؍ 0.72), late (>6 mo after transplantation) rejections (25.3 versus 21.2%; P ؍ 0.53), and adverse events were similar on azathioprine (n ؍ 124) and MMF (n , respectively. Outcomes in the two groups were comparable also among patients with or without steroid therapy, considered separately. In kidney transplantation, the long-term risk/benefit profile of MMF and azathioprine therapy in combination with cyclosporine Neoral is similar. In view of the cost, standard immunosuppression regimens for kidney transplantation should perhaps include azathioprine rather than MMF.
Journal of the American Society of Nephrology, 2007
The Mycophenolate Steroids Sparing (MYSS) study found that in renal transplant recipients who were on immunosuppressive therapy with the cyclosporine microemulsion Neoral, mycophenolate mofetil (MMF) was not better than azathioprine in preventing acute rejection at 21 mo after transplantation and was 15 times more expensive. The MYSS Follow-up Study, an extension of MYSS, was aimed at comparing long-term outcome of 248 MYSS patients according to their original randomization to MMF (1 g twice daily) or azathioprine (75 to 100 mg/d). Primary outcome was estimated GFR at 5 yr after transplantation. Mean 5-yr GFR difference between azathioprine and mycophenolate was 4.67 ml/min per 1.73 m 2 (95% confidence interval [CI] ؊0.43 to 9.77 ml/min per 1.73 m 2 ; P ؍ 0.07). GFR from month 6 (mean ؎ SEM: 54.3 ؎ 1.6 versus 53.9 ؎ 1.5 ml/min per 1.73 m 2 ; P ؍ 0.83) to month 72 after transplantation (49.5 ؎ 2.2 versus 47.3 ؎ 2.4 ml/min per 1.73 m 2 ; P ؍ 0.50); GFR slopes (mean ؎ SEM: ؊1.10 ؎ 0.56 versus ؊1.23 ؎ 0.31 ml/min per 1.73 m 2 per year; P ؍ 0.83); and 72-mo patient mortality (4.0 versus 4.0% [P ؍ 0.95]; HR 0.96; 95% CI 0.28 to 3.31; P ؍ 0.95), graft loss (6.8 versus 6.1% [P ؍ 0.82]; HR 0.89; 95% CI 0.32 to 2.46; P ؍ 0.83), incidence of persistent proteinuria (25.0 versus 27.4%; P ؍ 0.72), late (>6 mo after transplantation) rejections (25.3 versus 21.2%; P ؍ 0.53), and adverse events were similar on azathioprine (n ؍ 124) and MMF (n ؍ 124), respectively. Outcomes in the two groups were comparable also among patients with or without steroid therapy, considered separately. In kidney transplantation, the long-term risk/benefit profile of MMF and azathioprine therapy in combination with cyclosporine Neoral is similar. In view of the cost, standard immunosuppression regimens for kidney transplantation should perhaps include azathioprine rather than MMF.
Mycophenolate mofetil reduces late renal allograft loss: a 4-year study
Transplantation Proceedings, 2002
Background. Mycophenolate Mofetil (MMF) has been shown to significantly decrease the number of acute rejection episodes in renal transplant recipients during the 1st year. A beneficial effect of MMF on long-term graft survival has been more difficult to demonstrate. This beneficial effect has not been detected, despite the impact of acute rejection on the development of chronic allograft nephropathy and experimental evidence that MMF may have a salutary effect on chronic allograft nephropathy independent of that of rejection. Methods. Data on 66,774 renal transplant recipients from the U.S. renal transplant scientific registry were analyzed. Patients who received a solitary renal transplant between October 1, 1988 and June 30, 1997 were studied. The Cox proportional hazard regression was used to estimate relevant risk factors. Kaplan-Meier analysis was performed for censored graft survival. Results. MMF decreased the relative risk for development of chronic allograft failure (CAF) by 27% (risk ratio [RR] 0.73, P<0.001). This effect was independent of its outcome on acute rejection. Censored graft survival using MMF versus azathioprine was significantly improved by Kaplan-Meier analysis at 4 years (85.6% v. 81.9%). The effect of an acute rejection episode on the risk of developing CAF seems to be increasing over time (RR,9.1؍ 1988 -91; RR,9.2؍ 1992-94; RR,7.3؍ 1995-97).
Transplantation Proceedings, 2005
Introduction. The use of mycophenolate mofetil (MMF) in renal transplantation results in a 50% lower incidence of acute rejection compared to azathioprine (AZA). However, the graft survival reports are conflicting: the European trial and US database analysis suggest better survival with MMF, an observation that was not seen in the US and tricontinental studies. Methods. We retrospectively reviewed our single-center experience (60% African-Americans) comparing the serum creatinine (SCr) values and 3-year actual graft survival with MMF versus AZA-based immunosuppression. Group I included patients transplanted between January 1990 and December 1992 on cyclosporine (CSA), AZA, and steroids; group II subjects, from January 1996 to December 1998 on CSA, MMF, and steroids. We analyzed SCr and all causes of graft losses at 3, 6, 12, 18, 24, and 36 months posttransplantation.
Lancet
Mycophenolate mofetil has replaced azathioprine in immunosuppression regimens worldwide to prevent graft rejection. However, evidence that its antirejection activity is better than that of azathioprine has been provided only by registration trials with an old formulation of ciclosporin and steroid. We aimed to compare the antirejection activity of these two drugs with a new formulation of ciclosporin. The mycophenolate steroids sparing multicentre, prospective, randomised, parallel-group trial compared acute rejections and adverse events in recipients of cadaver-kidney transplants over 6-month treatment with mycophenolate mofetil or azathioprine along with ciclosporin microemulsion (Neoral) and steroids (phase A), and over 15 more months without steroids (phase B). The primary endpoint was occurrence of acute rejection episodes. Analysis was by intention to treat. 168 patients per group entered phase A. 56 (34%) assigned mycophenolate mofetil and 58 (35%) assigned azathioprine had c...
American Journal of Transplantation, 2004
Chronic allograft nephropathy (CAN) is the main cause of graft failure after the first year of transplantation. This prospective, centrally randomized, open-label study was conducted to examine the possibility that mycophenolate mofetil (MMF) can prevent the emergence of CAN. The incidence of biopsy-proven CAN at 1 year was compared between two cyclosporine-based regimens comprising either mycophenolate mofetil (MMF) or azathioprine (AZA). The AZA group (n = 34) and the MMF group (n = 37) were balanced for all baseline characteristics of donors and recipients, the pre-existence of renal lesions on donor biopsy, the incidence of delayed graft function and acute rejection. Based on an intent-to-treat analysis, the number of patients with CAN at 1 year post-transplantation was significantly reduced in the MMF group (17/37-46%) compared with the AZA group (24/34-71%) (p = 0.03). When observed data were considered, 56/71 (78.8%) patients had a 1-year biopsy, and the number of patients with CAN was significantly lowered in the MMF group (9/29-31%) compared with the AZA group (17/27-63%) (p = 0.01). These results suggest a beneficial effect of MMF on the incidence of CAN at 1 year post-transplantation.
Mycophenolate Mofetil: Ten Years' Experience of a Renal Transplant Unit
Transplantation Proceedings, 2008
Mycophenolate mofetil (MMF) use in renal transplantation has allowed a significant decrease in early acute rejection rates. We retrospectively evaluated the incidence of acute rejection episodes, renal function at the first year posttransplant, patient and graft survivals, cytomegalovirus (CMV) infection rate, influence of the degree of sensitization, and number of MHC antigen mismatches on graft survival in two groups of patients receiving either MMF or azathioprine. Group 1 included 149 patients receiving cyclosporine, MMF, and prednisolone; group 2 included 191 patients receiving cyclosporine, azathioprine, and prednisolone. The two groups did not differ in terms of age, sex, degree of sensitization (expressed as percentage of antibodies reactive to panel), MHC mismatch number, cold ischemia time, donor age, or anti-thymocyte globulin induction. In group 1 (MMF) there was a significant decrease in early acute rejection rate (19% vs 57%, P Ͻ .0001), longer graft survival at 10 years (92% vs 75%, P ϭ .006), and higher rate of CMV infection (22% vs 12%, P ϭ .004). Renal function at the first year posttransplant and patient survival during follow-up did not differ between the groups. The degree of sensitization influenced graft survival in group 2. The number of MHC mismatches did not influence graft survival in either group. With MMF, there was a significant reduction in early acute rejection rate, a significant increase in graft survival at 10-year follow-up, and diminished impact of the degree of sensitization on graft survival.
Nephrology Dialysis Transplantation, 2012
Background. We assess our long-term experience with regards the safety and efficacy of Mycophenolate Mofetil (MMF) in our low risk renal transplant population and compared it retrospectively to Azathioprine (AZA) immunosuppressive regimen. Patients and methods. Between January 1999 and December 2005, 240 renal transplants received MMF as part of their immunosuppressive protocol (MMF group). AZA group of 135 renal transplants was included for comparative analysis (AZA group). Patients received Cyclosporine was excluded from this study. Results. The incidence of biopsy proven 3-month acute rejections was 30 (12.5%) in MMF group and 22 (16%) in AZA group respectively (P = 0.307). Patient survival rates at 1 and 5 years for the MMF group were 97 and 94%, respectively, compared to 100% and 91% at 1 and 5 years respectively for the AZA group (P = 0.61). Graft survival rates at 1 and 5 years for the MMF group were 95 and 83%, respectively, compared to 97 and 84% at 1 and 5 years, respectively for the AZA group (P = 0.62).