Inhaled Anti-Rejection Drug Boosts Lung Transplant Survival

But the medication is not available for widespread use, study notes

WEDNESDAY, Jan. 11, 2006 (HealthDay News) -- The anti-rejection drugs patients receive after lung transplants are so strong they can sometimes kill. But a new, small study finds that inhaling these medications increases patients' two-year survival by nearly 50 percent.

The patients in the study inhaled cyclosporine, an experimental version of the drug normally given by mouth or injection to reduce the immune system attack on the transplanted tissue.

These types of delivery methods affect the body as a whole, raising side-effect risks such as severe kidney and liver damage. But the researchers pointed out that inhalation delivers cyclosporine mainly to the area of transplant.

"Many people die of the drugs we give to prevent rejection," noted study co-author Dr. Bruce A. Johnson, an assistant professor of medicine at the University of Pittsburgh, where the study was done. By using inhalation, he said, "we can give the drug right where the rejection is recurring, reducing the risk of side effects."

Inhalation also allows for the use of a much higher dosage, added Dr. Aldo T. Iacono, the lead author of the study. He now is director of lung transplantation at the University of Maryland Medical Center in Baltimore.

"You couldn't ethically give these [high] doses by the oral route because of toxicity, and also because of the effect on the immune system," Iacono said. "They could potentially depress the immune system and leave the patient open to opportunistic infections that could be fatal."

His team published its findings in the Jan. 12 issue of the New England Journal of Medicine.

The trial included 58 people who received lung transplants. Nearly half inhaled measured doses of cyclosporine during the six weeks following their operation, in addition to the usual treatment to prevent rejection. The others received conventional treatment.

Inhaled cyclosporine did not reduce the incidence of severe rejection episodes, the study authors found. But just three of the 28 patients who inhaled the drug died within two years, compared to 14 of the 30 patients who did not get the treatment.

"This is the first time we have data showing an impact on the most common reason for a lung transplant to fail after the first year," said Dr. Malcolm M. DeCamp, Jr., who wrote an accompanying editorial in the journal. He was director of lung transplantation at the Cleveland Clinic and is now chief of the division of cardiothoracic surgery at Beth Israel Deaconess Medical Center in Boston.

The drawback with the study is its small size and "as with any single-institution study, the results need to be confirmed by a larger investigation of its efficacy," DeCamp said.

Such a study is being considered, Johnson said, but plans are complicated by commercial interests. The pharmaceutical company Chiron Corp. has the rights to the drug, and it is in the process of being acquired by another drug company, Novartis, Johnson said. The hope is that a larger study might begin this year, he said.

Meanwhile, inhalable cyclosporine is also in a legal limbo, lacking approval by the U.S. Food and Drug Administration. It potentially could help the estimated 1,700 people who have lung transplants worldwide each year, the researchers said.

"No center has access to it," Iacono said. "This is a tragic problem, because the results are very promising and there is no other therapy to prevent this problem from occurring. I hope this report helps resurrect the issue."

More information

For more on lung transplantation, visit the National Library of Medicine.

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