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New drug is effective in reducing rejection in heart transplantation

lantation from bacterial rather than opportunistic infections. A careful review found that the patients who received daclizumab also received an additional immunosuppressive drug called cytolytic therapy to treat complications soon after surgery.

Because the study was double-blinded, clinical investigators didn't know which patients were receiving daclizumab and which were not. Patients who received cytolytic therapy continued to receive five doses of daclizumab during a seven-week period. As a result, some patients were treated with up to five different drugs - standard triple-drug therapy, daclizumab and cytolytic drug therapy - that may have predisposed them to bacterial infection.

"The investigators thought that this was a concerning and clinically relevant signal that the prolonged use of daclizumab following cytolytic therapy, can cause increased bacterial infection," said Hershberger. "In real practice, after cytolytic therapy becomes a necessary treatment in the first few days post-transplant, physicians would not continue giving additional doses of daclizumab and I think it's unlikely that we'd see this level of infection in those cases. The study results indicate that daclizumab should not be used following cytolytic therapy."

The study was sponsored by the maker of daclizumab, Roche Laboratories.

"Most heart transplant physicians use what they know works. Even though I'm the first author, analyzed the data and wrote the paper, I have been waiting for this study to be published and to receive critical review by the transplant community before recommending we adopt it in our program, said Hershberger.

Since it started in 1985, OHSU's Heart Transplant Program has transplanted more than 460 hearts.


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Contact: Christine Pashley
pashleyc@ohsu.edu
503-494-8231
Oregon Health & Science University
30-Jun-2005


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