PMID- 15848574
OWN - NLM
STAT- MEDLINE
DCOM- 20050926
LR  - 20161124
IS  - 0041-1345 (Print)
IS  - 0041-1345 (Linking)
VI  - 37
IP  - 2
DP  - 2005 Mar
TI  - Safety assessment of the conversion from mycophenolate mofetil to enteric-coated 
      mycophenolate sodium in stable renal transplant recipients.
PG  - 916-9
AB  - The immunosuppressant mycophenolate mofetil (MMF; CellCept) has greatly improved 
      transplant recipients' clinical outcomes, but its efficacy may be limited by dose 
      adjustments due to adverse events (AEs). An enteric-coated formulation of 
      mycophenolate sodium (EC-MPS; myfortic), designed to improve gastrointestinal 
      tolerability is now available. This Latin-American, prospective, multicenter, 
      open-label, 6-month trial assessed the safety and tolerability of converting 
      renal transplant recipients from MMF to EC-MPS. In total, 237 renal transplant 
      recipients (stable > or = 3 months' posttransplant) receiving MMF (< or =1000 mg 
      b.i.d.) were enrolled. Adults (n = 218) were converted to EC-MPS 720 mg b.i.d. 
      (equimolar to MMF 1000 mg b.i.d.) even if they were initially receiving <1000 mg 
      MMF b.i.d. (ie, 47 adults received a higher than equimolar dose of EC-MPS). 
      Children (n = 19) were converted to EC-MPS 450 or 432 mg/m2 b.i.d. Patients also 
      received cyclosporine microemulsion (Neoral) and corticosteroids. There were 
      three acute rejections and no graft failures. The incidence of AEs was 59.9% (in 
      those receiving a higher than equimolar EC-MPS dose it was 57.4%). In all, 22% of 
      patients had gastrointestinal AEs, 37% had infections, and 4.8% had hematological 
      AEs. Only 24 patients (10%) had an AE-related dose reduction. Seven of these 
      patients had received higher than equimolar doses of EC-MPS. Patients can be 
      safely converted from different doses of MMF to a standard dose of EC-MPS. The 
      requirement for EC-MPS dose reduction to manage AEs was relatively low. Use of 
      EC-MPS is a valid alternative for renal transplant recipients receiving 
      maintenance MMF treatment.
FAU - Massari, P
AU  - Massari P
AD  - Servicio de Nefrologia, Hospital Privado Centro Medico, Cordoba, Argentina. 
      pmassari@arnet.com.ar
FAU - Duro-Garcia, V
AU  - Duro-Garcia V
FAU - Giron, F
AU  - Giron F
FAU - Hernandez, E
AU  - Hernandez E
FAU - Juarez, F
AU  - Juarez F
FAU - Castro, C
AU  - Castro C
FAU - Toledo, M
AU  - Toledo M
CN  - myPROMS LatAm Study Group
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
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  - AYI8EX34EU (Creatinine)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Creatinine/blood
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/adverse effects/therapeutic use
MH  - Kidney Transplantation/*immunology
MH  - Latin America
MH  - Male
MH  - Mycophenolic Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Postoperative Complications/epidemiology
MH  - Safety
MH  - Skin Neoplasms/epidemiology
MH  - Tablets, Enteric-Coated
EDAT- 2005/04/26 09:00
MHDA- 2005/09/27 09:00
CRDT- 2005/04/26 09:00
PHST- 2005/04/26 09:00 [pubmed]
PHST- 2005/09/27 09:00 [medline]
PHST- 2005/04/26 09:00 [entrez]
AID - S0041-1345(04)01458-7 [pii]
AID - 10.1016/j.transproceed.2004.12.020 [doi]
PST - ppublish
SO  - Transplant Proc. 2005 Mar;37(2):916-9. doi: 10.1016/j.transproceed.2004.12.020.