Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: results of an Asia-Pacific study

Nephrology (Carlton). 2013 Jan;18(1):57-62. doi: 10.1111/nep.12007.

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Asia
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Kidney Transplantation*
  • Male
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / analogs & derivatives*
  • Prospective Studies
  • Tablets, Enteric-Coated

Substances

  • Immunosuppressive Agents
  • Tablets, Enteric-Coated
  • Mycophenolic Acid