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Title: Kidney Transplant Patients Benefit From Calcineurin Inhibitor Withdrawal Regimen
URL: http://www.pslgroup.com/dg/223D66.htm
Doctor's Guide
June 19, 2008

WASHINGTON, DC -- June 19, 2008 -- Withdrawing certain immunosuppressive drugs following kidney transplantation prolongs survival compared with keeping patients on these medications for life, according to a study appearing in the September 2008 issue of the Journal of the American Society Nephrology. In this study, a lifetime Markov model was created to compare a sirolimus-based calcineurin inhibitor (CNI) withdrawal regimen (sirolimus plus steroids) with other common CNI-containing regimens in adult de novo renal transplantation patients. The findings indicate that in the long run, the risks of the medications potentially outweigh their benefits.

Head-to-head analyses of the short-term benefits and long-term risks of CNIs are limited. To compare the 2, Stephanie Earnshaw, MD, Research Triangle Institute Health Solutions, Research Triangle Park, North Carolina, and her colleagues examined data from published studies and from the US transplant registry. The investigators developed a decision-analytic model to assess long-term donor kidney survival and short- and long-term patient outcomes. Dr. Earnshaw's group compared treatments containing sirolimus plus steroids versus treatments that maintained the use of CNIs.

The researchers' decision-analytic model, using data published in the literature and reported by the US transplant registry, assumed that within the first 12 months following transplant surgery, sirolimus plus steroid therapy was associated with a greater risk of kidney allograft rejection compared with regimens that continue to use CNIs.

In this particular study, it was assumed that in the absence of induction therapy, a total of 21.8% of patients taking sirolimus plus steroids experienced acute rejection within 1 year of transplantation compared with 19.0% of patients taking cyclosporine plus mycophenolate mofetil and steroids, and 17.1% of patients taking tacrolimus plus mycophenolate mofetil and steroids.

However, it was revealed that overall, treatment with sirolimus plus steroids may be more efficacious compared with regimens that continued to use CNIs. Specifically, withdrawal of CNIs may prolong patients' lives and improve their kidney function.

It was estimated that the average number of grafts lost per patient over their remaining lifetime after initial kidney transplantation was 0.90 for patients taking sirolimus plus steroids compared with 0.94 for patients in the cyclosporine group and 0.92 for patients in the tacrolimus group. Sirolimus plus steroids also may increase patient survival.

According to the authors, these findings indicated that "calcineurin inhibitor withdrawal … shows potential for long-term clinical benefits." They noted that withdrawal of CNIs is an important option because clinicians consider the lifetime of the patient to be more important than the year that follows transplantation. It is important to note that this analysis relied on certain assumptions due to limited availability of data. As such, additional research will be necessary to support these results.


SOURCE: American Society of Nephrology

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