{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,2]],"date-time":"2026-03-02T10:33:16Z","timestamp":1772447596526,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2006,11,9]],"date-time":"2006-11-09T00:00:00Z","timestamp":1163030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2007,1]]},"abstract":"<jats:p><jats:bold>Abstract:\u2002<\/jats:bold> To examine the efficacy and safety of enteric\u2010coated mycophenolate sodium (EC\u2010MPS, <jats:italic>myfortic<\/jats:italic><jats:sup>\u00ae<\/jats:sup>) in renal transplant patients with diabetes mellitus, six\u2010 and 12\u2010month data from three clinical trials with EC\u2010MPS (Studies B301, B302, and <jats:italic>my<\/jats:italic>PROMS) were analyzed <jats:italic>post hoc<\/jats:italic>. Studies B301 (<jats:italic>de novo<\/jats:italic> patients) and B302 (maintenance patients) followed a randomized double\u2010blind design whereas <jats:italic>my<\/jats:italic>PROMS was an open\u2010label study in <jats:italic>de novo<\/jats:italic> and maintenance renal transplant patients in which all patients received EC\u2010MPS as part of their immunosuppressive regimen. In studies B301 and B302, diabetic patients were compared against mycophenolate mofetil (MMF, CellCept<jats:sup>\u00ae<\/jats:sup>), the reference drug. For <jats:italic>my<\/jats:italic>PROMS, data from diabetic and non\u2010diabetic patients were compared. In total, 246 diabetic patients receiving EC\u2010MPS were analyzed. In study B301, the efficacy failure rate [biopsy\u2010proven acute rejection (BPAR), graft loss, death or loss to follow\u2010up] in diabetics at 12\u2003months was 17.6% (EC\u2010MPS) vs. 26.2% (MMF), and of BPAR alone 14.7% vs. 19.0% (both n.s.). In <jats:italic>de novo<\/jats:italic> patients from <jats:italic>my<\/jats:italic>PROMS, the treatment failure rate was similar in diabetic (20.3%) and non\u2010diabetic 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\u2010MPS and MMF in <jats:italic>de novo<\/jats:italic> patients. This was supported by the safety results assessed in maintenance patients (B302) indicating no increased safety risk with the use of EC\u2010MPS 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\u2010MPS was not different to non\u2010diabetics in <jats:italic>my<\/jats:italic>PROMS. In conclusion, preliminary data suggest that EC\u2010MPS in combination with cyclosporine (\u00b1 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\u2010MPS. More data from prospective studies are needed to fully judge the efficacy and safety profile of EC\u2010MPS in the diabetic transplant population.<\/jats:p>","DOI":"10.1111\/j.1399-0012.2006.00615.x","type":"journal-article","created":{"date-parts":[[2006,11,9]],"date-time":"2006-11-09T17:12:49Z","timestamp":1163092369000},"page":"117-125","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and safety of enteric\u2010coated mycophenolate sodium in renal transplant patients with diabetes mellitus: <i>post hoc<\/i> analyses from three clinical trials"],"prefix":"10.1111","volume":"21","author":[{"given":"Frank","family":"Pietruck","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klemens","family":"Budde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurizio","family":"Salvadori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans","family":"Sollinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Bourbigot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel 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