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

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dc.contributor.authorArinsoy, T.
dc.contributor.authorUslu, A.
dc.contributor.authorMir, S.
dc.contributor.authorTitiz, I.
dc.contributor.authorGonenc, F.
dc.contributor.authorCelik, A.
dc.contributor.authorApaydin, S.
dc.contributor.authorKacar, S.
dc.contributor.authorGuvence, N.
dc.contributor.authorTurkmen, A.
dc.date.accessioned2019-10-27T21:24:31Z
dc.date.available2019-10-27T21:24:31Z
dc.date.issued2011
dc.departmentEge Üniversitesien_US
dc.description22nd Congress of the Spanish-Liver-Transplantation-Society (SETH) -- OCT 29-30, 2010 -- Madrid, SPAINen_US
dc.description.abstractObjective. 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.en_US
dc.description.sponsorshipSpanish Liver Transplantation Socen_US
dc.identifier.doi10.1016/j.transproceed.2010.11.020en_US
dc.identifier.endpage832en_US
dc.identifier.issn0041-1345
dc.identifier.issue3en_US
dc.identifier.pmid21486608en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage826en_US
dc.identifier.urihttps://doi.org/10.1016/j.transproceed.2010.11.020
dc.identifier.urihttps://hdl.handle.net/11454/44571
dc.identifier.volume43en_US
dc.identifier.wosWOS:000289860300038en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofTransplantation Proceedingsen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.titleEvaluation of Efficacy and Safety of Mycophenolate Sodium in Patients With De Novo and Maintenance Renal Transplantation: Results of a Multicenter, Prospective, Observational Studyen_US
dc.typeArticleen_US

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