PMID- 16797288
OWN - NLM
STAT- MEDLINE
DCOM- 20060822
LR  - 20161124
IS  - 0041-1345 (Print)
IS  - 0041-1345 (Linking)
VI  - 38
IP  - 5
DP  - 2006 Jun
TI  - Efficacy and safety of enteric-coated mycophenolate sodium (myfortic) in de novo 
      renal transplant recipients: results of a 12-month multicenter, open-label, 
      prospective study.
PG  - 1301-6
AB  - Enteric-coated mycophenolate sodium (EC-MPS) has been developed as an alternative 
      formulation of mycophenolate acid aiming for improved gastrointestinal (GI) 
      tolerability. This 12-month, open-label, multicenter, prospective study 
      investigated the efficacy and tolerability of EC-MPS (720 mg twice a day) given 
      in combination with cyclosporine microemulsion (CsA-ME) in de novo renal 
      transplant recipients (n=140). The efficacy evaluation was the incidence of 
      treatment failure (defined as biopsy-proven acute rejection [BPAR], graft loss, 
      or death) after 6 and 12 months of treatment. The incidences of treatment 
      failure, BPAR, and graft loss were comparable at 6 and 12 months (18.6% vs 22.1%, 
      15.7% vs 19.3%, and 1.4% vs 2.1%, respectively). Renal function at 6 and 12 
      months (creatinine clearance) was 60.6+/-19.8 mL/min and 63.2+/-27.1 mL/min, 
      respectively. EC-MPS was generally well tolerated; 95.9% of the reported GI 
      adverse events (AEs) were rated as mild or moderate. The rate of EC-MPS dose 
      reduction was 26.4%; 4.3% were due to GI AEs. The rate of EC-MPS dose 
      interruption was 10%; 2.1% were due to GI AEs. In summary, EC-MPS given in 
      combination with CsA-ME demonstrates good efficacy and tolerability in de novo 
      renal transplant recipients.
FAU - Vogt, B
AU  - Vogt B
AD  - Division of Nephrology and Hypertension, Inselspital, University of Berne, Berne, 
      Switzerland. bruno.vogt@chuv.ch
FAU - Antoniadis, A
AU  - Antoniadis A
FAU - Klinger, M
AU  - Klinger M
FAU - Vitko, S
AU  - Vitko S
LA  - eng
PT  - 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  - Adult
MH  - Aged
MH  - Creatinine/metabolism
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/therapeutic use
MH  - Kidney Function Tests
MH  - Kidney Transplantation/*immunology/physiology
MH  - Male
MH  - Middle Aged
MH  - Mycophenolic Acid/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Safety
MH  - Tablets, Enteric-Coated
MH  - Time Factors
MH  - Treatment Failure
MH  - Treatment Outcome
EDAT- 2006/06/27 09:00
MHDA- 2006/08/23 09:00
CRDT- 2006/06/27 09:00
PHST- 2006/01/18 00:00 [received]
PHST- 2006/06/27 09:00 [pubmed]
PHST- 2006/08/23 09:00 [medline]
PHST- 2006/06/27 09:00 [entrez]
AID - S0041-1345(06)00215-6 [pii]
AID - 10.1016/j.transproceed.2006.02.125 [doi]
PST - ppublish
SO  - Transplant Proc. 2006 Jun;38(5):1301-6. doi: 10.1016/j.transproceed.2006.02.125.