A different form of a well-known immunosuppressive drug given to lung transplant patients within 6 weeks following surgery can significantly improve their long-term survival, according to a follow-up clinical trial released at a medical conference in Philadelphia this month.1
The drug is known as cyclosporine, a medication that has "markedly improved the survival and quality of life of patients in the past 2 decades," write medical experts.2
Long-Term Benefits Studied
In a double blind, randomized, placebo-controlled trial, whose results after about 53 months (about 4.5 years) of follow-up were released at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) in early April, Aldo Iacono, MD, and his colleagues evaluated the efficacy of inhaled cyclosporine in 56 patients.
The patients were divided at random into one of two groups. One group was given doses of 300 mg of cyclosporine and the second group was given aerosol placebo three days a week for a total of 2 years.
Earlier Promising Findings
Iacono and his team initially released data last year on the survival odds of using cyclosporine, which also suggested that the medication was beneficial. The latest study was an extended, 10-month follow-up to the initial research in an effort to gather longer-term information. According to Iacono, who heads the lung transplant program at the University of Maryland School of Medicine, cyclosporine was linked with a survival rate of as much as 84% compared with 56% in the group given placebo over the average 4.5 year follow-up. The reduced risk of death was estimated to be about 70% in the group given cyclosporine. That compares to estimates by the ISHLT that puts the survival rate of a double-lung transplant recipient at about 65% three years afterwards.3
In the earlier study, Iacono's team estimated survival with inhaled cyclosporine at 79%, meaning the survival benefit was maintained in the longer follow-up period.
Patients in this study underwent either single or double lung transplantation and were already receiving standard oral immune suppression.
A New Way to Receive Immune Suppression
Cyclosporine is currently available in oral and liquid form. However, Chiron Corporation late last year submitted a new drug application to the Food and Drug Administration for approval of an inhaled form of the drug. Delivery directly to the lungs through inhalation would route higher concentrations of the medication directly to the transplanted organ. The FDA granted the application Priority Review Status, meaning the review process will be expedited due to the fact that the medicine would fill a currently unmet medical need.4 "Approximately 4,000 patients in the United States are currently awaiting lung transplants, and Pulminiq [the drug's trade name] could significantly benefit those fortunate enough to receive transplants," said Craig Wheeler, Chiron's president, in a statement.
Currently, cyclosporine is prescribed to decrease the risk of kidney, liver and heart transplant rejection. Rejection problems in bone marrow transplants are also treated with the drug.
According to Chiron, side effects that were likely associated with inhaled cyclosporine in previous studies included bronchospasm, shortness of breath, and airway irritation.
1. Iacono A, Capra W, Shrewbury S et al. Long-term follow up of a double-blind, randomized, placebo-controlled trial of cyclosporine inhalation solution (CIS) in lung transplant recipients. 25th Anniversary Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT). 2005 April 6-9. Philadelphia, PA.
2. Zuckerman A, Klepetko W. Use of cyclosporine in thoracic transplantation. Transplant Proc 2004 Mar;36(2 Suppl):331S-336S.
3. International Society for Heart & Lung Transplantation (ISHLT). ISHLT Transplant Registery Quarterly Reports for Lung in North America. Survival rates for transplants performed between October 1, 1999 and September 30, 2003. Available at: http://www.ishlt.org/registries/quarterlyDataReportResults.asp?organ=LU&rptType=tx_p_surv&continent=4. Accessed April 28, 2005.
4. Chiron News Release. 2004 Dec 15.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
