New drug is effective in reducing rejection in heart trans...( ate mofetil and corticosteroids in add...),Health

The study found that the rate of rejection was 25 percent lower in the daclizumab group of patients than in the placebo group. Within six months of their heart transplants, 77 of the 216 patients in the daclizumab group reached the primary end point (rejection, heart dysfunction, death or loss to follow up), compared with 104 of the 218 patients in the placebo group (36 percent versus 48 percent). There was no survival difference between patients who received placebo and daclizumab.

In addition, researchers noted that it took three times longer for the patients in the daclizumab group to reach the primary end point than it did for those in the placebo group (61 versus 21 days). The one-year follow-up indicated the same advantage.

These results confirmed what scientists discovered in an earlier study conducted on only 55 heart transplant patients at one medical center and another study of organ rejection in kidney transplant patients.

"We're always trying to improve transplantation results. Prior to the approval of cyclosporine in 1983, the death rate in the first year after transplant was 70 percent to 80 percent. With cyclosporine it fell to 20 percent to 30 percent. Today, a good heart transplant program should have no more than a 15 percent death rate. But this number is still too high," said Hershberger. "The results of this study are an incremental step in a long road to improving outcomes for heart transplant patients."

Patients in both study groups had infections that commonly occur in transplant patients when anti-rejection medication weakens their immune systems. These opportunistic infections are caused by viruses or fungus that live in the body and take advantage of weakened immune systems following transplantation.

However, six patients in the daclizumab group versus none in the placebo group died during the first year after transp
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Contact: Christine Pashley
pashleyc@ohsu.edu
503-494-8231
Oregon Health & Science University
30-Jun-2005