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Fujisawa Healthcare Release: Ninety Six Percent Patient Survival Rate Shown In First-Ever Multi-Center, Double-Blind Study Of Early Steroid Withdrawal In Kidney Transplant Recipients



10/19/2005 5:11:26 PM

BOSTON, May 18 /PRNewswire/ -- An interim analysis of a first-of-its-kind, multi-center, double-blind antibody induction clinical study evaluating a tacrolimus (TAC or Prograf(R)) + mycophenolate mofetil (MMF or CellCept(R)) steroid withdrawal regimen vs. a TAC + MMF steroid maintenance regimen in primary renal transplant patients presented today at the 5th American Transplant Congress indicates positive outcomes for all patients.

Clinical results after Year 1 report that nearly 96 percent of participants survived and maintain a functioning graft, and nearly 85 percent of those patients did not experience any kind of rejection. In addition, the study has seen exceptionally low overall acute rejection rates (biopsy confirmed) for the 386 participating patients (10.6 percent), and very low severe acute rejections, defined as greater than or equal to 2A or treatment with antibody, (only 4.7 percent). The incidence of PTDM is also low (7 percent) in patients without diabetes at baseline. Pre-transplant, there was a high prevalence of multiple coronary heart disease (CHD) risk factors including diabetes, hypertension, hyperlipidemia and history of cardiovascular disease. After the first year, patients experienced an overall decrease in global CHD risk.

"Side effects associated with the use of steroids in transplant patients, including unwanted hair growth, marked facial swelling, weight gain, post- transplant diabetes and osteoporosis, are a major concern for transplant recipients and their physicians," said E. Steven Woodle, M.D., lead investigator for the study. "The initial results of this major clinical study indicate a strong trend towards safe and effective use of a tacrolimus +MMF- based regimen with minimal use of steroids."

Study Design

The prospective, randomized, double-blind, stratified, multi-center study examined early corticosteroid cessation vs. long-term maintenance corticosteroid therapy with Prograf and CellCept in primary renal transplant patients. Patients were required to meet the rigid inclusion and exclusion criteria to participate in the study. The primary endpoint of the 5-year study is a composite of death, graft loss or severe acute rejection at 6 months, and 1 year through the completion of the study. All of the nearly 400 clinical study participants received induction therapy for the first seven days of the study and were then randomized to either a regimen of Prograf + CellCept, or Prograf + CellCept + steroids (5mg/day by 6 months). While the primary endpoint of the study focuses on patient survival, graft survival and severe acute rejection, the secondary endpoints of the study evaluate:

   -- Rejection severity by BANFF criteria
   -- Proportion of patients requiring anti-lymphocyte therapy for
      acute rejection
   -- Patient and graft survival
   -- Incidence of post-transplant diabetes mellitus and infections
   -- Change in Framingham Heart Study Coronary Heart Disease Risk
      Point Total
   -- Incidence and severity of hypercholesterolemia (total
      cholesterol, HDL cholesterol, LDL cholesterol) and
      hypertryglyceridemia and treatment of hyperlipidemia Incidence
      and severity of hypertension
   -- Incidence of post-transplant malignancies
   -- Incidence of leukopenia
   -- Cumulative steroid dose
   -- Patient weight change

"The overall goal of the 5-year study is to develop a safe and effective protocol that will minimize use of steroids in transplant patients, without compromising patient and graft survival," said Dr. Woodle. "With these positive Year 1 initial results, we are well on our way to achieving the study's objective."

About Prograf and Fujisawa Healthcare, Inc.

Prograf is indicated for the prophylaxis of organ rejection in patients receiving kidney or liver transplant and has been marketed in North America, Europe and Japan. Worldwide, Prograf is commercially available in 68 countries. Currently more than 60% of new kidney transplant recipients take Prograf. Only experienced physicians and qualified facilities should mange patients prescribed Prograf. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Insulin dependent post transplant diabetes occurred in up to 20% of patients but was reversible in some patients. Black and Hispanic kidney transplant patients were at an increased risk. Common adverse reactions are nephrotoxicity, neurotoxicity, gastrointestinal disturbances, hypertension and infection. Prograf is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with a hypersensitivity to castor oil. For full prescribing information, visit http://www.prograf.com/ or contact Fujisawa Healthcare, Inc. at 1-800-727-7003.

Fujisawa Healthcare, Inc. is headquartered in Deerfield, Ill., develops, manufactures, and markets proprietary products in the United States. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd. based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe, and Asia. Additional information on Fujisawa Healthcare, Inc. and its products can be found on the Internet at http://www.fujisawa.com/.

Fujisawa Healthcare, Inc.

CONTACT: Maribeth Landwehr, (on-site at ATC), +1-847-317-8988, or SarahOrenic (on-site at ATC), +1-312-933-828, both for Fujisawa Healthcare, Inc.


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