PMID- 14974945
OWN - NLM
STAT- MEDLINE
DCOM- 20040916
LR  - 20230124
IS  - 1600-6135 (Print)
IS  - 1600-6135 (Linking)
VI  - 4
IP  - 2
DP  - 2004 Feb
TI  - Enteric-coated mycophenolate sodium can be safely administered in maintenance 
      renal transplant patients: results of a 1-year study.
PG  - 237-43
AB  - 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/mm3) 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.
FAU - Budde, Klemens
AU  - Budde K
AD  - University Hospital Charite, Berlin, Germany. klemens.budde@charite.de
FAU - Curtis, John
AU  - Curtis J
FAU - Knoll, Gregory
AU  - Knoll G
FAU - Chan, Lawrence
AU  - Chan L
FAU - Neumayer, Hans-Hellmut
AU  - Neumayer HH
FAU - Seifu, Yodit
AU  - Seifu Y
FAU - Hall, Michael
AU  - Hall M
CN  - ERL B302 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Transplant
JT  - American journal of transplantation : official journal of the American Society of 
      Transplantation and the American Society of Transplant Surgeons
JID - 100968638
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Tablets, Enteric-Coated)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
CIN - Am J Transplant. 2005 May;5(5):1164; author reply 1165-6. PMID: 15816903
MH  - Biotransformation
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Graft Rejection/epidemiology
MH  - Humans
MH  - Immunosuppressive Agents/pharmacokinetics/therapeutic use
MH  - Incidence
MH  - Kidney Transplantation/*immunology
MH  - Mycophenolic Acid/*pharmacokinetics/therapeutic use
MH  - Postoperative Complications/classification/epidemiology
MH  - Safety
MH  - Tablets, Enteric-Coated
MH  - Time Factors
EDAT- 2004/02/21 05:00
MHDA- 2004/09/17 05:00
CRDT- 2004/02/21 05:00
PHST- 2004/02/21 05:00 [pubmed]
PHST- 2004/09/17 05:00 [medline]
PHST- 2004/02/21 05:00 [entrez]
AID - S1600-6135(22)29312-5 [pii]
AID - 10.1046/j.1600-6143.2003.00321.x [doi]
PST - ppublish
SO  - Am J Transplant. 2004 Feb;4(2):237-43. doi: 10.1046/j.1600-6143.2003.00321.x.