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| |  Transplant 2001: Rapamune (Sirolimus) Enables Elimination of Cyclosporine, Preserves Kidney Function CHICAGO, IL -- May 15, 2001 -- New data presented at the Transplant 2001 meeting may indicate a solution to the kidney damage that can occur with use of the anti-rejection drug cyclosporine. Rapamune® (sirolimus), an anti- rejection drug for patients receiving kidney transplants, successfully replaced cyclosporine during a yearlong study following transplantation with no significant increase in rejection rates and significantly improved renal function in patients who were taking Rapamune without cyclosporine. The results of the study were presented yesterday at Transplant 2001, the joint meeting of the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). "One of the disappointing paradoxes of kidney transplantation has always been that the standard therapy used to prevent kidney rejection can actually damage the new kidney, resulting in the need for a new transplant," said Dr. Donald E. Hricik, M.D., the lead investigator of the study at Case Western Reserve University School of Medicine. "Rapamune offers a solution to that paradox by maintaining healthy kidney function while preventing organ rejection." Case Western Reserve University School of Medicine was one of 17 sites in the United States and Europe. The year-long study compared two groups of patients who received either Rapamune and cyclosporine or Rapamune with cyclosporine eliminated three months after transplant. Cyclosporine is commonly used after kidney transplantation to prevent organ rejection and is known to be toxic to the kidney. The study investigated differences in the rate of kidney toxicity and organ rejection between the two groups. In the Phase II, open-labeled, randomized study, 97 patients received a full dose of cyclosporine plus a fixed dose of Rapamune (2 mg/day). A second group of 100 patients on cyclosporine received enough Rapamune to maintain a blood concentration of the drug in the range of 10-12 nanograms/ml. At the end of the second month following transplantation, any patient in the group maintaining 10-12 nanograms/ml Rapamune who had not had a significant instance of kidney rejection was weaned off cyclosporine over a one-month period. All patients also received a standard treatment with corticosteroids. At the end of 12 months, there were no significant differences between the two groups in the rate of organ rejection and patient survival; however, renal function was significantly better in patients who were taking Rapamune as base therapy (cyclosporine eliminated). Rapamune as base therapy reduced the risk of kidney damage -- and the need for another transplant," said Dr. Hricik. Six-month data from a larger multi-national study that was also presented at the Transplant 2001 meeting begin to confirm the findings of improved renal function that Dr. Hricik and others concluded from the Phase II study. These results, from 525 patients, reinforced that Rapamune is an effective alternative to cyclosporine for reducing the risk of rejection while maintaining good kidney function. "With this confirmation we have even more reason to be confident that Rapamune will improve outcomes for patients receiving kidney transplants," said Dr. Hricik. "This therapy could be a significant quality of life enhancement for transplant patients and their families." Rapamune is manufactured and marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products, which provided funding for this study.
SOURCE: Case Western Reserve University School of Medicine Related Links: Wyeth-Ayerst Laboratories and American Home Products.
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