PMID- 15350440
OWN - NLM
STAT- MEDLINE
DCOM- 20050324
LR  - 20211203
IS  - 0041-1345 (Print)
IS  - 0041-1345 (Linking)
VI  - 36
IP  - 6
DP  - 2004 Jul-Aug
TI  - Stable renal transplant recipients can be safely converted from MMF to 
      enteric-coated mycophenolate sodium tablets: Interim results of a multicenter 
      Latin American study.
PG  - 1647-9
AB  - Enteric-coated mycophenolate sodium (EC-MPS) is designed to reduce mycophenolate 
      acid (MPA)-related upper gastrointestinal (GI) adverse events (AEs). A 
      multicenter, open-label, Latin American study in stable renal transplant patients 
      is ongoing to assess the safety of the conversion from mycophenolate mofetil 
      (MMF) to EC-MPS. An interim analysis was performed when 93 patients had completed 
      3 months. Prior to conversion, they had received MMF at a dose of 2 g/d, with the 
      exception of eight adult patients who were receiving an average daily dose of 
      1.25 g. All adult patients were converted to EC-MPS (1.44 g/d; 0.450 g/m(2) bid 
      for children). After conversion, the reported total incidence of AEs was 40.9%, 
      including 28% infections, 1.1% hematologic, 19.4% GI, including 10.8% upper-GI AE 
      (all mild) and 5.4% diarrhea. No patient discontinued the study medication due to 
      adverse events. Only six patients (6%) required a dose adjustment. There were no 
      episodes of acute rejection, death, or graft loss. During the period of analysis, 
      the conversion from MMF to EC-MPS was safe, the enteric-coated tablet formulation 
      prevented release of MPA in the upper GI tract, and only one patient had to 
      reduce the dose due to an upper GI AE, concomitant with diarrhea. EC-MPS offers 
      transplant physicians and their patients an alternative MPA therapy that is as 
      effective and safe as MMF, but in a formulation that may provide GI tolerability 
      benefits.
FAU - Abbud-Filho, M
AU  - Abbud-Filho M
AD  - Instituto de Urologia e Nefrologia and Medical School of Rio Preto, Sao Jose do 
      Rio Preto, Brazil. mabbud@terra.co.br
FAU - Giron, F
AU  - Giron F
FAU - Hernandez, E
AU  - Hernandez E
FAU - Juarez, F
AU  - Juarez F
FAU - Liendo, C
AU  - Liendo C
FAU - Novoa, P
AU  - Novoa P
FAU - Toledo, M
AU  - Toledo M
CN  - Myproms Latam Study Group
LA  - eng
PT  - Clinical Trial
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Transplant Proc
JT  - Transplantation proceedings
JID - 0243532
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Tablets, Enteric-Coated)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Ethnicity
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/*therapeutic use
MH  - Kidney Transplantation/*immunology
MH  - Latin America
MH  - Male
MH  - Mycophenolic Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/*therapeutic use
MH  - Racial Groups
MH  - Tablets, Enteric-Coated
MH  - Time Factors
EDAT- 2004/09/08 05:00
MHDA- 2005/03/25 09:00
CRDT- 2004/09/08 05:00
PHST- 2004/09/08 05:00 [pubmed]
PHST- 2005/03/25 09:00 [medline]
PHST- 2004/09/08 05:00 [entrez]
AID - S0041-1345(04)00813-9 [pii]
AID - 10.1016/j.transproceed.2004.07.031 [doi]
PST - ppublish
SO  - Transplant Proc. 2004 Jul-Aug;36(6):1647-9. doi: 
      10.1016/j.transproceed.2004.07.031.