Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: Results of an Asia-Pacific study
Journal
Nephrology
Journal Volume
18
Journal Issue
1
Pages
57-62
Date Issued
2013
Author(s)
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.
SDGs
Other Subjects
creatinine; mycophenolic acid; mycophenolic acid 2 morpholinoethyl ester; abdominal distension; acne; acute graft rejection; adult; anemia; arthralgia; article; Asian; behavior; Bowen disease; cellulitis; coughing; creatinine blood level; creatinine clearance; diarrhea; drug efficacy; drug safety; drug withdrawal; enteric coated tablet; feasibility study; female; fever; glomerulus filtration rate; graft failure; graft recipient; headache; herpes zoster; human; immunosuppressive treatment; incidence; interstitial nephritis; kidney transplantation; leukopenia; maintenance therapy; major clinical study; male; multicenter study; open study; phase 3 clinical trial; polyomavirus infection; priority journal; prospective study; rhinopharyngitis; rhinorrhea; skin papilloma; upper abdominal pain; upper respiratory tract infection; urinary tract infection; Adult; Asia; Female; Humans; Immunosuppressive Agents; Kidney Transplantation; Male; Mycophenolic Acid; Prospective Studies; Tablets, Enteric-Coated
Type
journal article