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Sirolimus-Based Therapy Results in 90% Graft Survival in High-Risk Kidney Transplant Patients After 1 Year: Presented at ASN

By Ed Susman

SAN DIEGO, CA -- November 20, 2006 -- Sirolimus-based anti-rejection therapy resulted in 90% graft survival after 1 year in high-risk patients, whether combined with tacrolimus or cyclosporine, doctors said here at the 39^th annual meeting of the American society of Nephrology (ASN).

The high-risk patients included African Americans, patients who had a second transplant and patients with high-panel reactive antibodies, groups that have difficulty in retaining their transplanted organs.

"Our team of investigators was able to determine that sirolimus, in combination with tacrolimus or cyclosporine, can be an effective and safe therapy when initiated immediately post-transplant in patients already at the highest risk for organ rejection," said Osama Gaber, MD, director of transplantation, Methodist Hospital, Houston, Texas.

Dr. Gaber completed his study while working at the University of Tennessee, Memphis. He presented the study in a poster session on November 17^th.

In the study, 448 patients were randomly assigned to either sirolimus and tacrolimus or sirolimus and cyclosporine. After 1 year, the graft survival was 89.7% in the tacrolimus arm and 90.2% in the cyclosporine arm -- essentially no difference between the 2 calcineurin inhibitors.

Acute rejection episodes occurred in 21.9% of patients in the tacrolimus arm and 23.2% of the cyclosporine arm of the study -- again no statistical difference (P = .821).

At 12 months, when evaluating the patient population on an intention-to-treat basis, the Nankivell glomerular filtration rate was 54.5 mL/min in the sirolimus plus tacrolimus patients and 52.6 mL/min in the sirolimus plus cyclosporine patients. This difference was not statistically significant (P = .408).

"Managing the nephrotoxic effects of calcineurin inhibitors is 1 of the challenges facing physicians in kidney transplant cases," said Barry Kahan, MD, professor of surgery and director, organ transplantation center, University of Texas Medical School, Houston, Texas. "We know that sirolimus works by a novel mechanism of action that differs from the calcineurin inhibitors and is non-toxic to kidneys."


[Presentation title: A Comparison of Sirolimus and Tacrolimus vs. Sirolimus and Cyclosporine in High-Risk Renal Allograft Recipients: 12-Month Results from an Open-Label, Randomized Trial. Abstract F-PO1089]

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