PROGRAF AND RAPAMUNE

New Study Combines Prograf(R) with Rapamune(R) or CellCept(R) in the Treatment of Kidney Transplant Patients DEERFIELD, Ill., Aug. 29 /PRNewswire/ -- Results of a clinical study combining Prograf(R) (tacrolimus)-based immunosuppression with Rapamune(R) (sirolimus) or CellCept(R) (mycophenolate mofetil) were presented today at the XIX International Congress of The Transplantation Society in Miami, Florida. The incidence of biopsy proven acute rejection in patients undergoing kidney transplantation proved to be low in both therapeutic combinations. Additionally, patients assigned to the Prograf-CellCept combination experienced better renal function and exhibited less cardiovascular risk factors including hyperlipidemia and diastolic hypertension. "Studies such as this that show Prograf can be combined safely with these other agents, while maintaining its proven efficacy, provide transplant physicians with the added comfort they need to confidently prescribe Prograf to their patients," stated leading clinical investigator and presenter of the study data Harold C. Yang, M.D., Ph.D., of PinnacleHealth in Harrisburg, PA. During the study, 361 patients enrolled at 27 transplant centers throughout the United States were randomized to receive Prograf plus corticosteroids and either Rapamune (n=185) or CellCept (n=176) prior to their kidney transplant. Patients were followed for six months post-transplant. The incidence of biopsy proven acute rejection, the primary endpoint in the study, was similarly low in both groups studied (13.0% in the Rapamune group and 11.4% in the CellCept group). In addition to the primary endpoints, patient and graft survival, renal function, composite endpoints and adverse events were also evaluated. Patient and graft survival were similarly good in each group at 97.3% and 93.0%, respectively, in the Rapamune group and 97.7% and 95.5%, respectively, in the CellCept group.