Prospective randomized pilot study of steroid withdrawal with mycophenolate mofetil in long-term cyclosporine-treated patients: 4-year follow-up

Budde, Klemens; Geißler, Sven; Hallebach, G; Waiser, Johannes; Fritsche, Lutz; Böhler, Torsten; Neumayer, Hans‐Hellmut

doi:10.1016/s0041-1345(02)02990-1

Cited by 13 publications

(11 citation statements)

References 10 publications

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“…At 18 months after cessation of steroid therapy, the prednisone withdrawal group had a lower mean blood pressure and similar renal function and patient and graft survival than controls (Table 1). Another randomized study, which was smaller, but had a longer follow-up (4.5 years), showed that there was no difference in graft function and graft survival between patients on steroids and those who had been withdrawn later than 1 year post transplant [20]. None of these patients suffered from acute rejection during 4.5 years of follow-up.…”

Section: Steroid Withdrawal In Adult Renal Transplant Recipients On Mmfmentioning

confidence: 97%

Steroid withdrawal in pediatric and adult renal transplant recipients

2005

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Corticosteroids are still a cornerstone in the immunosuppressive regimen in pediatric renal transplant recipients despite their numerous side effects, such as inhibition of longitudinal growth, body disfigurement, arterial hypertension, cardiovascular complications, osteopathy, and others. Previous attempts to spare steroids in cyclosporine (CsA)-based protocols have been associated with an increased risk for acute rejection episodes. The recent introduction of more-potent immunosuppressive medications, such as mycophenolate mofetil (MMF), have, however, renewed interest in steroid-sparing protocols to avoid or ameliorate steroid-associated side effects. Recent studies in Caucasian adult renal transplant recipients receiving CsA and MMF have shown a beneficial effect of late (>/=6 months post transplant) steroid withdrawal on steroid-associated side effects without the burden of an increased rate of acute rejection episodes. These favorable results compared with previous reports in patients on CsA and azathioprine (AZA) can be ascribed to the higher immunosuppressive potency of MMF compared with AZA. We have shown in a retrospective case control study in 40 pediatric renal transplant recipients that late steroid withdrawal is safe and successful in stable patients under an immunosuppressive maintenance therapy with CsA and MMF. The Mid-European Study Group on Pediatric Renal Transplantation and the Arbeitsgemeinschaft fur Padiatrische Nephrologie are currently performing a prospective randomized trial to validate these observations.

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Section: Steroid Withdrawal In Adult Renal Transplant Recipients On Mmfmentioning

confidence: 97%

Steroid withdrawal in pediatric and adult renal transplant recipients

2005

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“…In patients receiving cyclosporine and/or azathioprine/mycophenolate based immunosuppression, complete steroid withdrawal is successful in around 70-85% of patients [40][41][42][43][44]. There is a significant decrease in steroid related complications after steroid withdrawal, though mortality is not reduced.…”

Section: Steroid Withdrawal After Renal Transplantationmentioning

confidence: 99%

“…The incidence of graft loss at 1-year post transplant was 2.6% for patients taking MMF compared with 6.3% for patients taking azathioprine or placebo. Both the European and the U.S. studies showed a trend towards an improved graft survival at 3 and 4 years, respectively in patients taking MMF [44,73]. There was no significant difference in markers of chronic rejection (mean serum creatinine and proteinuria) between patients treated with MMF and control patients [70].…”

Section: Mmf In Renal Transplantationmentioning

confidence: 99%

Immunosuppressive agents in solid organ transplantation: Mechanisms of action and therapeutic efficacy

Taylor

Watson

Bradley

2005

Critical Reviews in Oncology/Hematology

381

250

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“…A prospective, randomized, controlled study is currently being undertaken by the German Pediatric Renal Transplant Study Group to corroborate these observations. In this context it is noteworthy that controlled, randomized, prospective trials on late steroid withdrawal (Ն6 months posttransplant) in white adult renal transplant recipients receiving CsA and MMF have yielded favorable results (21,23,24). In one study, for example, the incidence of biopsy-proven acute rejection episodes in 76 patients who underwent steroid withdrawal 6 months posttransplant was only 3.9% compared with 1.4% in controls; graft function and graft survival were similar over an observation period of 18 months (23).…”

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confidence: 99%