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• W1973145786 abstract "The recent Journal article reporting the outcome of the Tricontinental Mycophenolate Mofetil Renal Transplant Study Group (1) raises more questions than it answers. While I commend the authors on their extensive statistical analysis of the data, the clinical relevance and implications of adding mycophenolate mofetil (MMF) to maintenance cyclosporine(CsA)-based immunotherapy in the long-term may have been overstated or misinterpreted. In contradistinction to the multicenter FK506 trial(2), which showed no statistical difference in the incidence of acute rejection at 1 year between CsA- and FK506-based immunosuppression (P = 0.12, χ2), the current study did in fact show a statistically significant decrease in biopsy-proven rejection at 6 months for the MMF 2 g/day group versus the azathioprine (AZA) group(19.7% vs. 35.5%, P = 0.002, χ2). Whether this will result in increased long-term graft survival is purely conjectural at this time. The fact that rejection tended to be more prevalent in both MMF groups versus the AZA group between 6 and 12 months suggests that the beneficial effects may be dampened in the long term. Furthermore, because the authors appear to have included the seven patients in the AZA group who never demonstrated graft function, the incidence of treatment failure was artificially elevated in the AZA arm of the study. If one excludes patients with no graft function (see Table 1 in 1), failure due to graft loss or death (Table 3) is actually lowest (although not statistically) in the AZA group. Nonetheless, the current study is of great interest because it demonstrates that the greatest risk of rejection occurs during the first month after transplantation. It is here that MMF appears to offer its greatest benefit, since the slopes of the graphs analyzing treatment failure parallel one another after this initial period (Figs. 1 and 2). If the beneficial effects of MMF are indeed limited to the first month after transplant, its use may be better confined to that of induction therapy rather that maintenance immunotherapy. This being the case, it would be of great clinical interest to investigate the circumstances under which acute rejection occurred during the first month. It may be that the addition of MMF helped compensate for the inadequate level of immunosuppression afforded in the early postoperative period to those patients with impaired CsA absorption. Unfortunately, since CsA doses were adjusted on the basis of serum trough levels rather than total CsA exposure (area under the time-concentration curve), it is likely that analysis will underestimate the effect that underdosing CsA had on permitting acute rejection to occur. Even so, a retrospective analysis of CsA trough levels preceding biopsy-proven rejection might be enlightening. What, then, should be taken away from this study? First, although not specifically addressed by this study, it is becoming increasingly apparent that the addition of AZA to double therapy with CsA/prednisone is of little, if any, benefit. Second, MMF may be useful in preventing acute rejection during the first month after transplant. As many of us now shift toward either cyclosporine microemulsion- or tacrolimusbased immunosuppression-both of which are well absorbed in the early postoperative period-it is unclear what role MMF should play in our immunosuppressive arsenal. Further study and long-term follow-up are clearly required before wholesale changes in either induction or maintenance immunotherapy should be advocated. Barry J. Browne1 Department of Surgery; Temple University; Philadelphia, Pennsylvania 19140" @default.
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• W1973145786 date "1996-12-01" @default.
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• W1973145786 title "THE TRICONTINENTAL MYCOPHENOLATE MOFETIL TRIAL" @default.
• W1973145786 cites W2609602266 @default.
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• W1973145786 doi "https://doi.org/10.1097/00007890-199612150-00033" @default.
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