Premium
Enteric‐Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1‐Year Study
Author(s) -
Budde Klemens,
Curtis John,
Knoll Gregory,
Chan Lawrence,
Neumayer HansHellmut,
Seifu Yodit,
Hall Michael
Publication year - 2004
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1046/j.1600-6143.2003.00321.x
Subject(s) - medicine , mycophenolic acid , tolerability , adverse effect , mycophenolate , neutropenia , clinical endpoint , gastroenterology , transplantation , immunosuppression , incidence (geometry) , urology , randomized controlled trial , toxicity , physics , optics
With the objective of enhancing upper gastrointestinal (GI) tolerability, enteric‐coated mycophenolate sodium (EC‐MPS, myfortic ® , Novartis Pharma AG, Basel, Switzerland) has been developed. This double‐blinded, 12‐month study investigated whether renal transplant patients taking mycophenolate mofetil (MMF) can be safely converted to EC‐MPS. Stable kidney transplant patients were randomized to receive EC‐MPS (720 mg b.i.d.; n = 159) or continue receiving MMF (1000 mg b.i.d.; n = 163). The incidence of GI adverse events (AEs) was similar at 3 months (primary endpoint: EC‐MPS 26.4%; MMF 20.9%; p = NS) and at 12 months (EC‐MPS 29.6%; MMF 24.5%; p = NS). The increase from baseline in mean GI AE severity score, adjusted for duration, tended to be lower in EC‐MPS patients (3 months: 0.15 vs. 0.20; 12 months: 0.23 vs. 0.47; p = NS). Neutropenia (<1500 cells/mm 3 ) within the first 3 months (coprimary endpoint) was low in both groups (EC‐MPS 0.6%; MMF 3.1%; p = NS). Although the overall incidence of infections was similar, the number of serious infections was significantly lower in EC‐MPS patients (8.8% vs. 16.0%; p < 0.05). Similar rates of efficacy failure (EC‐MPS 2.5%; MMF 6.1%; p = NS), biopsy‐proven acute rejection (EC‐MPS 1.3%; MMF 3.1%; p = NS) and biopsy‐proven chronic rejection (EC‐MPS 3.8%; MMF 4.9%; p = NS) were observed in both groups. In conclusion, renal maintenance patients can be converted from MMF to EC‐MPS without compromising the safety and efficacy profile associated with MMF.