Budde 2007
ID: 5bfd474f7aaac8379380578b
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Estudio primario

No clasificado

Safety and efficacy of reduced or full dose of cyclosporine (neoral®) in combination with mycophenolate sodium (Myfortic®), basiliximab (Simulect®), and steroids in de novo kidney transplant recipients

Revista Transplantation
Año 2004
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Estudio primario

No clasificado

Reduced cyclosporine exposure is safe and efficacious in combination with basiliximab, enteric‐coated mycophenolate‐sodium, and steroids

Revista American Journal of Transplantation
Año 2005
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Estudio primario

No clasificado

How much exposure is needed in the first week in patients receiving induction with basiliximab and enteric coated mycophenolate sodium?

Revista American Journal of Transplantation
Año 2005
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Estudio primario

No clasificado

Safety and tolerability of enteric coated mycophenolate sodium in combination with neoral and steroids in de novo kidney transplant recipients: 12 months analysis of a prospective trial

Revista Nephrology
Año 2005
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Estudio primario

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Tolerability of enteric coated mycophenolate sodium (EC‐MPS) in combination with neoral and steroids in de novo kidney transplant recipients: a 12 months prospective trial

Revista American Journal of Transplantation
Año 2005
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Estudio primario

No clasificado

Reduced‐exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric‐coated mycophenolic acid and basiliximab

Revista Journal of the American Society of Nephrology
Año 2006
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Estudio primario

No clasificado

Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab.

Revista Clinical nephrology
Año 2007
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BACKGROUND: The lower limit of exposure to calcineurin inhibitors has not yet been established in de novo renal transplant patients receiving mycophenolic acid therapy with basiliximab. METHODS: A 12-month, multicenter, randomized, open-label trial was carried out in which de novo renal transplant patients received enteric-coated mycophenolate sodium, cyclosporine microemulsion, steroids and basiliximab. Patients were randomized to receive standard-exposure (n = 45) or reduced-exposure (n = 44) cyclosporine, based on differing C2 target ranges, after the first month post-transplant. RESULTS: Cyclosporine exposure gradually increased over the first month and was lower than previously recommended. Mean calculated creatinine clearance (primary end-point) was similar in the standard-exposure and reduced-exposure groups at month 6 (55.3+/-3.2 ml/min and 61.5+/-3.7 ml/min respectively, n.s.). There were 4 deaths but no death-censored graft losses, resulting in 95.5% patient and graft survival at one year in both groups. At 6 and 12 months, the incidence of biopsy-proven acute rejection was 17.8% and 17.8% in the standard-exposure group, and 13.6% and 15.9% in the reduced-exposure group. Adverse events were similar between treatment groups. Exploratory analyses could not identify a lower limit for the optimal CsA exposure range, but results suggested that high exposure at one year was associated with deteriorating renal function. CONCLUSIONS: These results indicate that enteric-coated mycophenolate sodium with reduced-exposure cyclosporine, steroids and basiliximab induction has an excellent therapeutic effect and is safe in de novo kidney transplant recipients. Lower C2 targets than previously recommended, particularly early post-transplant, do not appear to be associated with compromised efficacy.

Estudio primario

No clasificado

Efficacy and safety of enteric-coated mycophenolate sodium in renal transplant patients with diabetes mellitus: post hoc analyses from three clinical trials.

Revista Clinical transplantation
Año 2007
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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 myPROMS) were analyzed post hoc. Studies B301 (de novo patients) and B302 (maintenance patients) followed a randomized double-blind design whereas myPROMS 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 myPROMS, 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 myPROMS, 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 myPROMS. 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.