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    Evaluation of Efficacy and Safety of Mycophenolate Sodium in Patients With De Novo and Maintenance Renal Transplantation: Results of a Multicenter, Prospective, Observational Study
    (Elsevier Science Inc, 2011) Arinsoy, T.; Uslu, A.; Mir, S.; Titiz, I.; Gonenc, F.; Celik, A.; Apaydin, S.; Kacar, S.; Guvence, N.; Turkmen, A.
    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.
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    Kidney Transplant Recipients with Functioning Grafts for More than 15 Years
    (Elsevier Science Inc, 2013) Celtik, A.; Alpay, N.; Celik, A.; Sezer, T. O.; Turkmen, A.; Camsari, T.; Toz, H.; Sever, M. S.; Hoscoskun, C.
    Background. Renal transplantation is the best renal replacement therapy because it significantly improves patient survival. The developments in transplantation and increasing number of patients with end-stage renal disease (ESRD) have unmasked long-term complications secondary to immunosuppressive drugs and chronic renal failure. Methods and Results. Eighty-six renal transplant recipients with grafts that have functioned more than 15 years were included in the study. This cross-sectional retrospective analysis of demographic, clinical, and laboratory findings was conducted in 3 Turkish transplantation centers. The mean age was 30.4 +/- 10.2 years at the time of the transplantation. The mean time between the transplantation and the study was 19.1 +/- 3.6 years. At the time of the study, mean creatinine level was 1.52 +/- 0.60 mg/dL, 70.09% of the patients displayed glomerular filtration rates <60 mL/min/1.73 m(2). Urinary protein excretion was 0.57 +/- 0.65 g/d. Hypertension and hyperlipidemia were the most common comorbid diseases. Twelve patients had diabetes and 9 cardiovascular disease. Seventeen patients had been diagnosed with skin and 5 with non-skin cancer. Conclusions. As the number of recipients with long-term functioning grafts increases, long-term complications become evident, particularly chronic renal failure. Survivors should be evaluated regularly and treated early for risk factors and complications to improve long-term graft and patient survival.