https://scholars.lib.ntu.edu.tw/handle/123456789/192035
標題: | Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Stable Maintenance Renal Transplant Patients: Pooled Results from Three International, Multicenter Studies | 作者: | Pietruck, F. Abbud-Filho, M. Vathsala, A. Massari, P.U. Po-Huang, L. Nashan, B. 李伯皇 |
關鍵字: | ACUTE REJECTION;GASTROINTESTINAL COMPLICATIONS;PREVENTION;RECIPIENTS;OUTCOMES | 公開日期: | 2007 | 卷: | v.39 | 期: | n.1 | 起(迄)頁: | 103-108 | 來源出版物: | TRANSPLANTATION PROCEEDINGS | 摘要: | Background. Mycophenolate mofetil (MMF) is effective in renal transplant patients but concerns remain over its gastrointestinal (GI) tolerability. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed with the intention of improving mycophenolic acid-related GI tolerability. Methods. Data were pooled in a planned analysis of three subprotocols of the myfortic Prospective Multicenter Study (n7yPROMS). In a 6-month study, efficacy and safety of converting stable renal transplant recipients from MMF to a bioequivalent dose of EC-MPS for mycophenolic acid exposure were evaluated. Treatment efficacy was recorded and graft function was assessed by measuring serum creatinine and estimating creatinine clearance . Adverse events (AEs) and infections were monitored and the incidence of EC-MPS dose changes was recorded. Results. A total of 588 patients were recruited, 564 (96%) of whom completed the study. The rate of treatment failure (defined as biopsy- proven acute rejection, graft loss, or death) was 1.9%, with no episodes of graft loss and only one death reported during the study. Renal function remained stable throughout the trial. EC- MPS was well tolerated; the majority of AEs were mild or moderate in severity. Dose reductions or interruptions were required by 6.3% and 1.9% of patients, respectively. Gastrointestinal AEs occurred in 138 patients( 23.5%). The rate of dose adjustment as a result of a GI AE was 2.2%. Conclusions. Equimolar conversion from MMF to EC- MPS in maintenance renal transplant patients was safe and maintained efficacy. |
URI: | http://ntur.lib.ntu.edu.tw//handle/246246/91778 |
顯示於: | 醫學系 |
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