Evaluation of Efficacy and Safety of Mycophenolate Sodium in Patients With De Novo and Maintenance Renal Transplantation: Results of a Multicenter, Prospective, Observational Study

Abstract Objective This study evaluates the effect of enteric-coated mycophenolate sodium (EC-MPS) on patient and graft survivals, the incidence of rejection episodes, and graft function among de novo and maintenance renal transplant recipients. Patients and Methods This open label, multicenter, prospective, post-marketing observational study of 470 renal transplantation patients at 23 centers in Turkey includes 331 de novo patients whose mean age was 29.6 ± 13.2 years and 139 maintenance patients of 34.0 ± 13.0 years. The latter subjects had EC-MPS substituted for mycophenolate mofetil or added to the immunosuppressive therapy. Patients were followed for 12 months to evaluate graft function and treatment failure. Results The most common primary disease requiring transplantation was glomerulonephritis (24.3%). De novo and maintenance groups were similar in terms of overall rejection rates and acute rejection incidence whereas chronic rejection was evident only among the latter cohort ( P < 0.001). Time to an acute rejection episode was significantly longer among maintenance rather than de novo patients (220.8 versus 18.7 months; P = 0.015). Overall, 12 and 36 month survival rates were 91.6 ± 1.3% and 86.9% ± 0.3% among subjects experiencing acute rejection versus 99.7 ± 0.2% and 50.3% for those displaying chronic rejection. Among maintenance group no deterioration of renal function was observed after conversion from mycophenolate mofetil to EC-MPS. The incidences of leukopenia, new-onset anemia, or liver dysfunction were similar between de novo and maintenance patients. Gastrointestinal discomfort was more prevalent among the maintenance group, reaching a significant level at the fourth visit ( P < 0.05). EC-MPS dose reduction was required in only 16.7% of patients at visit, it was more frequent among the de novo group (17.9 versus 13.8%). Conclusion EC-MPS was an effective adjunctive therapy for de novo as well as maintenance renal transplant recipients in the Turkish population due to a relatively low incidence of dose reductions necessitated by adverse events as well as with an increased likelihood of long-term graft survival.