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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



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



Transplantation Proceedings 38(5): 1301-1306



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 EGMPS (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 EGMPS dose reduction was 26.4%; 4.3% were due to GI AEs. The rate of EGMPS dose interruption was 10%; 2.1% were due to GI AEs. In summary, EGMPS given in combination with CsA-ME demonstrates good efficacy and tolerability in de novo renal transplant recipients.

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Accession: 012025754

Download citation: RISBibTeXText

PMID: 16797288

DOI: 10.1016/j.transproceed.2006.02.125



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