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| |  CellCept (Mycophenolate Mofetil) Reduces Long-Term Risk Of Kidney Rejection In Transplants TORONTO, ON -- July 19, 2000 -- The results from one of the largest-ever examinations of chronic transplant failure, have recently been published in the journal, Transplantation. The study, "Mycophenolate Mofetil Reduces Late Renal Allograft Loss Independent of Acute Rejection," is authored by Dr. Bruce Kaplan, Department of Internal Medicine, University of Michigan Medical Center, and his colleagues. Their research involved evaluation of 66,774 patients who received a new kidney between 1988 and 1997, and whose kidneys survived the first six months after transplant, confirming an effect suggested by much smaller studies at other centres. CellCept®, also known as mycophenolate mofetil or MMF, is an immunosuppressant. It was approved in Canada in 1996 for the prevention of organ rejection in kidney transplant recipients and in 1998 for use with patients undergoing heart transplantation, in combination with other immunosuppressants. In Dr. Kaplan's study, CellCept was found to be superior in its ability to reduce the risk of losing the new kidney due to chronic or long-term kidney failure -- compared to the conventionally used drug azathioprine (AZA). The effect was not just due to CellCept's ability to reduce acute rejection responses. In fact, the new results show the relative risk of chronic kidney failure is 27 per cent lower with CellCept, independent of its effect on acute rejection. Furthermore, CellCept and AZA are often used in conjunction with two other compounds as a "triple therapy", including corticosteroids and cyclosporine, to help suppress the body's immune response to a transplanted organ. As a result, CellCept has already become the standard of care in kidney and heart transplant centres across Canada. "For those who have endured the pain of kidney failure, the suspense of waiting for a transplant, ordeal of surgery and the hurdle of avoiding acute rejection, the threat of chronic rejection and loss of the kidney within a few years still looms," says Kaplan. "Our results, however, suggest that therapy that includes MMF (CellCept) may offer longer kidney and patient survival than AZA, by reducing the risk of both acute and chronic failure." Dr. Kaplan and his colleagues examined the four-year survival of both the kidneys and the patients, as recorded by the US Scientific Renal Transplant Registry. About 8,000 patients in the study population were treated with CellCept, either in clinical trials of the drug or after its approval in 1995, in order to evaluate its ability to prevent acute rejection. Findings demonstrate that CellCept protects against kidney loss due to chronic failure even when the effects of acute failure prevention were eliminated. Nearly 86 per cent of the CellCept-treated kidneys survived four years, compared with 82 per cent of kidneys treated with AZA. In an accompanying editorial, Dr. Harold Helderman of Vanderbilt University commented; "This paper is extraordinarily important to transplant practice. It provides clear and unambiguous outcome data to support the salutary effect of MMF (CellCept) on long term graft survival, beyond its short term effect on six month acute rejection rates". Here in Canada, according to Dr. Jeff Zaltzman, Director of Renal Transplantation at St. Michael's Hospital in Toronto, "It is rewarding to now see the impact on improvement in long-term allograft survival with the use of newer agents such as CellCept. In addition to its anti-rejection effects, this drug allows transplant physicians to reduce the dose of other medications such as cyclosporine in transplant recipients." According to the Kidney Foundation of Canada, there aren't enough organs to meet the current demand, so organs that are transplanted must last as long as possible. Protecting against chronic organ failure is important to the individual patient, and to the entire population of transplant candidates. A return to dialysis not only is a hardship for patients, but studies show that patients are at an increased risk for death due to heart disease if the body rejects a new organ. This recent study further demonstrates the impact that CellCept can have on the lives of kidney transplant recipients. Roche Canada also manufactures the innovative medication Cytovene®, used to prevent the life threatening infection cytomegalovirus (CMV) in kidney and liver transplant patients, as well as Zenapax®, an anti-rejection agent for renal transplant.
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