Reduced kidney transplant rejection rate and pharmacoeconomic advantage of mycophenolate mofetil.

with MMF (from sFr. 5906 to 9231 per patient for the first 6 months). Background. Several multinational controlled clinical trials have shown that triple therapy immunosuppres- Conclusions. The change from AZA to MMF resulted in a significant reduction in early rejection episodes, sive regimens which include mycophenolate mofetil (MMF ), cyclosporin A (CSA) and steroids (S ) are resulting in fewer diagnostic procedures and rehospitalizations. The optimal long-term regimen in terms of superior compared with conventional regimens which include azathioprine (AZA), CSA and S, mainly patient and pharmacoeconomic benefits remains to be defined. because MMF reduces the rate of acute rejection episodes in the first 6 months after kidney transplantation. Post-marketing studies are useful to evaluate the Key words: mycophenolate mofetil; pharmacoecongeneral applicability and costs of MMF-based omy; rejection; renal transplantation immunosuppressive regimens. Methods. Based on the excellent results of the published controlled clinical trials, we have changed Introduction the standard triple therapy immunosuppressive protocol (AZA+CSA+S) to an MMF-based regimen Several large randomized controlled clinical trials have (MMF+CSA+S ) at our centre. To analyse the impact demonstrated that the novel immunosuppressive drug of this change in regimen, we have monitored 6-month mycophenolate mofetil (MMF, CellCeptB) significpatient and graft survival, rejection rate, serum creatin- antly reduces the rate of early acute rejection episodes ine and CSA levels, as well as the costs of the immuno- after renal allograft transplantation when compared suppressive and anti-rejection treatments, in 40 with azathioprine (AZA) or placebo [1‐4]. The pooled consecutive renal transplant recipients (MMF group) 1-year eYcacy analysis of three clinical studies has and have compared the data with 40 consecutive shown that the MMF regimen reduced the rate of patients transplanted immediately prior to the change biopsy-proven acute rejection episodes from 40.8% in in regimen (AZA group). the AZA or placebo groups to 19.8% in the patients Results. Recipient and donor characteristics were sim- treated with 2 g of MMF per day [5]. Side eVects as ilar in the AZA and MMF groups. Patient survival well as infectious and neoplastic complications were (37/40; 92.5% in the AZA group vs 38/40; 95% in the similar with MMF. MMF group), graft survival (36/40 vs 36/40; both Despite the excellent results on the rate of acute 90%) and serum creatinine (137±56 vs 139±44 rejection episodes, the 1-year analysis has revealed that mmol/l ) after 6 months were not significantly diVerent. patient survival was not better with MMF (96%) However, the rate of acute rejection episodes (defined compared with the placebo/AZA regimens (95.3%). as a rise in creatinine without other obvious cause The graft survival with MMF (90.4%) was also similar and treated at least with pulse steroids) was signifi- when compared with placebo or AZA (87.6%) [5]. cantly reduced with MMF from 60 to 20% (P= Whether long-term benefits could result with the MMF 0.0005). The resulting cost for rejection treatment was regimen has not been investigated yet. The 3-year lowered 8-fold (from sFr. 2113 to 259 averaged per results suggest that a trend towards better graft survival patient) and the number of transplant biopsies was can be obtained with MMF [6,7]. lowered >3-fold in the MMF group. The cost for the Aside from the documented advantage for the immunosuppressive therapy was increased 1.5-fold patient treated with MMF, another important issue is the cost of immunosuppression. Analyses at 1 year