"Conventional anti-rejection drugs, which are given orally, do not get into the small air sacs of the lungs where chronic rejection takes place. It just makes a lot more sense to give a higher concentration of the drug right into the area you are trying to treat. Organ-specific immune suppression is almost a new paradigm for transplantation," according to Dr. Griffith, who is also director of Heart and Lung Transplantation at the University of Maryland Medical Center and the senior author of the article in the New England Journal of Medicine. Of the 26 patients in the study who received the inhaled cyclosporine, 23 were still alive two years later. However, of the 30 patients in the placebo group, only 16 were alive at the two-year point. The researchers report that the death rate in the cyclosporine group was 11 percent during the study compared to 47 percent for the placebo group.
"Our study shows for the first time that inhaled cyclosporine, taken in conjunction with oral anti-rejection medication, can protect patients from chronic rejection, which is the main reason that the average three-year survival rate from lung transplantation is only 55 percent--a much lower rate than for other solid organ transplants, including liver and kidney transplants," says Dr. Iacono.
Years of work led up to the clinical study. Dr. Griffith began doing basic research on the concept of an inhaled form of cyclosporine in 1988 while he was on the faculty of the University of Pittsburgh School of Medicine. He was the principal investigator on two federal grants, including one from the NIH for $1.7 million in 1998, which funded the clinical study now published in the New England Journal.
Dr. Iacono began working with Dr. Griffith at the University of Pittsburgh in 1992. When Dr. Griffith
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Contact: Ellen Beth Levitt
eblevitt@umm.edu
410-328-8919
University of Maryland Medical Center
11-Jan-2006