Preliminary six month findings of a Multicenter International Study of the organ rejection drug, Neoral, may offer significant benefits to heart transplant recipients. Clinical results obtained from 24 research centers in five countries were reported today at the International Society For Heart and Lung Transplantation Meeting in Chicago, Illinois.
According to Howard J. Eisen, M.D., Medical Director of the Heart Transplantation Unit at Temple University Hospital, "heart transplant patients receiving Neoral experienced significantly fewer infections and a reduced number of rejections requiring antibody therapy." This two-year, double blind International Study compares the safety and effectiveness of conventional Cyclosporine A (Sandimmune) with Neoral in 380 heart transplant recipients. All patients received either Sandimmune or Neoral as part of a triple immunosuppressive regimen including steroids and azathioprine.
"Since fewer Neoral-treated patients required supplemental steroids and antibody therapy, there were also fewer infections in these heart transplant recipients," says Dr. Eisen.
In addition, lower dosages of this immunosuppressive agent were needed during the initial four weeks after treatment to achieve therapeutic blood levels. Neoral is a new formulation of Cyclosporine designed to provide increased and more reliable absorption of the medication. These findings suggest that Neoral has clinical advantages, which may translate into improved outcomes for heart transplant recipients.
In 1995, the U.S. Food and Drug Administration approved Neoral for the prevention of organ rejection. Based upon scientific registry data from the United Network for Organ Sharing (UNOS), there are currently about 3,945 patients waiting for a heart transplant. "Due to the shortage of organ donors, we need to develop new treatments to prevent organ rejection in heart transplant patients," indicates Dr. Eisen.