Postmarketing evaluation of mycophenolate mofetil-based triple therapy immunosuppression compared with a conventional azathioprine-based regimen reveals enhanced efficacy and early pharmacoeconomic benefit after renal transplantation

Abstract

SEVERAL controlled clinical trials have shown that the novel immunosuppressive drug mycophenolate mofetil (MMF) significantly reduces the rate of early acute rejection episodes after renal allograft transplantation when compared with azathioprine (AZA) or placebo. The recently published pooled 1-year efficacy analysis of three large clinical studies has shown that the MMF regimen reduced the rate of biopsy-proven acute rejection episodes from 40.8% in the azathioprine or placebo groups to 19.8% in the patients treated with 2 g MMF per day. Therefore, triple-therapy regimens that include MMF, cyclosporin A (CsA), and steroids (S) appear to be superior and cost effective compared with conventional regimens that include AZA, CsA, and S by significantly reducing the rate of acute rejection episodes in the first year after kidney transplantation. Based on these results we have changed our standard triple-therapy immunosuppressive protocol (AZA 1 CsA 1 S) to an MMF-based regimen (MMF 1 CsA 1 S). We reasoned that by monitoring patient and graft survival, rejection rate, and transplant function and cost after 3 months, we could assess the early impact of a triple-therapy regimen containing MMF instead of AZA, particularly because the effect of MMF on the rejection rate is seen in the first 3 months after transplantation.