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Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation

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We report the 48-month results of a trial testing whether withdrawal of cyclosporine (CsA) from a sirolimus (SRL)-CsA-steroid (ST) regimen would impact renal allograft survival. Eligible patients receiving SRL-CsA-ST from transplantation were randomly assigned at 3 months to remain on triple therapy (SRL-CsA-ST, n = 215) or to have CsA withdrawn and SRL trough concentrations increased (SRL-ST, n = 215). SRL-ST therapy resulted in significantly better graft survival, either when including death with a functioning graft as an event (84.2% vs. 91.5%, P = 0.024) or when censoring it (90.6% vs. 96.1%, P = 0.026). Calculated glomerular filtration rate (43.8 vs. 58.3 ml/min, P < 0.001) and mean arterial blood pressure (101.3 vs. 97.1 mmHg, P = 0.047) were also improved with SRL-ST. Differences in the incidences of biopsy-proven acute rejection after randomization (6.5% vs. 10.2%, SRL-CsA-ST versus SRL-ST, respectively) and mortality (7.9% vs. 4.7%) were not significant. SRL-CsA-ST-treated patients had significantly higher incidences of adverse events generally associated with CsA, whereas those in the SRL-ST group experienced greater frequencies of events commonly related to higher trough levels of SRL. In conclusion, early withdrawal of CsA from a SRL-CsA-ST regimen rapidly improves renal function and ultimately results in better graft survival.
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Keywords: blood pressure; cyclosporine withdrawal; graft survival; renal function; sirolimus

Document Type: Research Article

Affiliations: 1: Allgemeines Krankenhaus-Wien, Vienna, Austria 2: Azienda Ospedaliera Molinette, Torino, Italy 3: Hospital Clinic i Provincial, Barcelona, Spain 4: Hôpital Necker, Paris, France 5: Hospitais da Universidade de Coimbra, Coimbra, Portugal 6: Queen Elizabeth II Health Science Centre, NS, Canada 7: The Queen Elizabeth Hospital, Woodville South, Australia 8: Hospital de Bellvitge, Barcelona, Spain 9: University of Bari, Bari, Italy 10: Rikshospitalet Nyreseksjonen, Oslo, Norway 11: Hospital Curry Cabral, Lisboa, Portugal 12: Westmead Hospital, Westmead, Australia 13: Wyeth Research, Paris, France 14: Wyeth Research, Collegeville, PA, USA

Publication date: 01 January 2005

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