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Title: Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: Results of an Asia-Pacific study
Authors: Lee, Po-Huang
Vathsala, Anantharaman 
Han, Duck Jong
Chan, Tak-Mao
Wong, Hin-Seng
Woodcock, Chad
Kurstjens, Nicol
Keywords: Science & Technology
Life Sciences & Biomedicine
Urology & Nephrology
clinical trial
immune suppression
Issue Date: 1-Jan-2013
Publisher: WILEY
Citation: Lee, Po-Huang, Vathsala, Anantharaman, Han, Duck Jong, Chan, Tak-Mao, Wong, Hin-Seng, Woodcock, Chad, Kurstjens, Nicol (2013-01-01). Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: Results of an Asia-Pacific study. NEPHROLOGY 18 (1) : 57-62. ScholarBank@NUS Repository.
Abstract: Aim Mycophenolate mofetil has proven efficacy in the prophylaxis of acute rejection in solid organ transplantation; however, gastrointestinal intolerance can risk this efficacy because of associated dose adjustments and discontinued treatment. Enteric-coated mycophenolate sodium has demonstrated improved gastrointestinal tolerability, but the data in Asian subjects are scarce. Methods This was a Phase-IIIb, open-label, single-arm, multicentre, prospective 6-month study which investigated safety and graft function in stable maintenance renal transplant recipients of Asian origin, after switching from mycophenolate mofetil to enteric-coated mycophenolate sodium at least 3 months after transplantation. Primary end-points included renal allograft function and safety parameters. Results The study recruited patients from 16 centres in Asian countries. The intention-to-treat and safety populations both included 122 patients. Graft function remained stable over the course of the study as measured by creatinine clearance and glomerular filtration rate. At 6 months the incidence of any gastrointestinal adverse events was 20.5% (n = 25), none of which required dose adjustments. There were only three cases of biopsy proven acute rejection with no reports of graft loss or death. Conclusion This study demonstrated that enteric-coated mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in Asian kidney transplant recipients. © 2012 The Authors. Nephrology © 2012 Asian Pacific Society of Nephrology.
Source Title: NEPHROLOGY
ISSN: 13205358
Appears in Collections:Staff Publications

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