Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: Results of an Asia–Pacific study
Article first published online: 17 DEC 2012
© 2012 The Authors. Nephrology © 2012 Asian Pacific Society of Nephrology
Volume 18, Issue 1, pages 57–62, January 2013
How to Cite
Lee, P.-H., Vathsala, A., Han, D. J., Chan, T.-M., Wong, H.-S., Woodcock, C., Kurstjens, N., Asia Pacific MyPROMS Study Investigators, Sivaraman, P., Chu, S.-H., Hsieh, H.-H., Hsu, K.-H., Lee, P.-C., Lian, J.-D., Yang, W.-C., Morad, Z., Tan, S.-Y., Han, D. J., Park, K. I., Siu, Y.-P. and Tsang, W. K. (2013), Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: Results of an Asia–Pacific study. Nephrology, 18: 57–62. doi: 10.1111/nep.12007
- Issue published online: 17 DEC 2012
- Article first published online: 17 DEC 2012
- Accepted manuscript online: 31 OCT 2012 09:25PM EST
- Manuscript Accepted: 24 OCT 2012
- Novartis Pharmaceuticals
- clinical trial;
- immune suppression;
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.
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.
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.
This study demonstrated that enteric-coated mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in Asian kidney transplant recipients.