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Title: Delayed Conversion From Standard Cyclosporine to Sirolimus Regimen Is Effective, Safe in Post-Renal Transplant: Presented at TTS
URL: http://www.pslgroup.com/dg/228956.htm
Doctor's Guide
August 14, 2008


By Rachel Parratt

SYDNEY, Australia -- August 14, 2008 -- Preliminary data from the Supporting Medication Adherence in Renal Transplantation (SMART) study show that the delayed introduction of a calcineurin inhibitor (CNI)-free, sirolimus (SRL)-based regimen 10 to 21 days post-transplant is as effective and safe as a cyclosporine (CsA)-based regimen.

Karl-Walter Jauch, MD, Department of Surgery, Grosshadern Clinic, University of Munich, Munich, Germany, presented the findings here on August 13 at the 22nd International Congress of the Transplantation Society (TTS 2008).

The potential benefit of a sirolimus and mycophenolate mofetil (MMF)-based immunosuppression is lack of CNI nephrotoxicity. However, the high rate of side effects observed in SRL-based CNI-free regimens may be due to ill-timed initiation of sirolimus post-transplant.

The study included 140 patients who were treated with a short course of CSA plus MMF 2 to 3 weeks after transplantation and then randomised to either SRL 8 to 12 ng/mL plus MMF 1.5 g/day or continued on CsA 200 to 250 ng/mL plus MMF 2 g/day. Both groups received steroids.

The rate of Banff 4 rejection episodes after conversion was not significantly different between the SRL arm (14%) and the CSA arm (9%).

Creatinine clearance (glomerular filtration rate) was significantly better in the CNI-free SRL group compared with the CsA group (P < .01).

Patient withdrawals were significantly higher in the SRL group (P < .03). Adverse events including all infections and wound complications were similar between groups.

However, cytomegalovirus infection was more frequent in the CsA arm (28%) compared with the SRL arm (6%) (P < .0001). The incidence of lymphoceles was 15% in the SRL arm and 24% in the CSA arm.

"Delayed introduction of a CNI-free, sirolimus-based regimen is equally safe compared to a CsA-based regimen in terms of surgical, immunological, and infectious complications post-renal transplant," said Dr. Jauch.

[Presentation title: Delayed Introduction of a Calcineurin-Inhibitor (CNI)-Free, Sirolimus (SRL)-Based Immunosuppression in Renal Transplantation Is Safe. Preliminary Results of the Randomised, Multicenter SMART Trial. Mini-Oral Session 18 WMO18]

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