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Efficacy and safety of enteric‐coated mycophenolate sodium in renal transplant patients with diabetes mellitus: post hoc analyses from three clinical trials
Author(s) -
Pietruck Frank,
Budde Klemens,
Salvadori Maurizio,
Sollinger Hans,
Bourbigot Bernard,
Gentil Miguel Angel,
Oppenheimer Frederic
Publication year - 2007
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2006.00615.x
Subject(s) - medicine , diabetes mellitus , mycophenolic acid , post hoc analysis , regimen , incidence (geometry) , population , clinical trial , mycophenolate , transplantation , surgery , gastroenterology , urology , endocrinology , environmental health , physics , optics
To examine the efficacy and safety of enteric‐coated mycophenolate sodium (EC‐MPS, myfortic ® ) in renal transplant patients with diabetes mellitus, six‐ and 12‐month data from three clinical trials with EC‐MPS (Studies B301, B302, and my PROMS) were analyzed post hoc . Studies B301 ( de novo patients) and B302 (maintenance patients) followed a randomized double‐blind design whereas my PROMS was an open‐label study in de novo and maintenance renal transplant patients in which all patients received EC‐MPS as part of their immunosuppressive regimen. In studies B301 and B302, diabetic patients were compared against mycophenolate mofetil (MMF, CellCept ® ), the reference drug. For my PROMS, data from diabetic and non‐diabetic patients were compared. In total, 246 diabetic patients receiving EC‐MPS were analyzed. In study B301, the efficacy failure rate [biopsy‐proven acute rejection (BPAR), graft loss, death or loss to follow‐up] in diabetics at 12 months was 17.6% (EC‐MPS) vs. 26.2% (MMF), and of BPAR alone 14.7% vs. 19.0% (both n.s.). In de novo patients from my PROMS, the treatment failure rate was similar in diabetic (20.3%) and non‐diabetic patients (27.1%), as was the incidence of BPAR (17.7% vs. 23.1%, both n.s.). The overall incidence, severity and pattern of AEs were comparable between EC‐MPS and MMF in de novo patients. This was supported by the safety results assessed in maintenance patients (B302) indicating no increased safety risk with the use of EC‐MPS in the diabetic patient population, if compared with MMF. Likewise, apart from a higher incidence of severe/serious infections in diabetics, the safety profile of EC‐MPS was not different to non‐diabetics in my PROMS. In conclusion, preliminary data suggest that EC‐MPS in combination with cyclosporine (± steroids) can be used efficiently and safely for the prophylaxis of organ rejection in diabetic renal transplant patients. Moreover, diabetic patients can apparently be safely converted from MMF to EC‐MPS. More data from prospective studies are needed to fully judge the efficacy and safety profile of EC‐MPS in the diabetic transplant population.