Jan 16 2006
According to a new study in the U.S., lung transplant patients live longer when they inhale the rejection-fighting drug Cyclosporine.
Around 1,700 lung transplants are done at 150 centers around the world each year, but this surgery is considered to be amongst the riskiest type of transplant surgery.
The long-term survival rate has changed little since the 1980s, and as a rule half of the recipients die within three years.
In the new study the death rate among the 28 patients selected to receive inhaled Cyclosporine was 11 percent, which is far below the rate of 47 percent among the 30 volunteers who inhaled a placebo.
Aldo Iacono, of the University of Pittsburgh Medical Center, who led the study, says they were surprised to see this level of survival.
Iacono, who is now at the University of Maryland in Baltimore, says the likelihood of long-term rejection was also lower, and he says this is the first therapy which is shown to prevent chronic rejection, and also the first to use a placebo and double-blind conditions to assess post-operative treatment.
The results are expected to be enthusiastically received by lung-transplant physicians and surgeons.
As yet no further tests of the inhaled form of Cyclosporine, known as Pulminiq, are planned by the company Chiron Corp. so it is unclear how the findings will be confirmed.
In mid 2005 a U.S. Food and Drug Administration advisory panel examined these results and were divided over whether the findings showed that the drug is effective as a lung transplant treatment and suggested more tests should be carried out.
However according to Iacono the only Pulminiq study under way is designed to test the effectiveness of the drug after other treatments have failed, and no new patients are being enrolled in that test.
He says the inability to give the drug to new transplant recipients, even on an experimental basis, is "a major issue".
Critics however say the new study has its shortcomings.
It seems the number of patients who signed up was less than half of the desired number, and only half the volunteers were able to stay with the two-year treatment.
They say the drug did not cut down on the instances of short-term rejection, which is apparently a typical measure of success.
It is believed that better cooperation between medical centers is needed to find the optimal treatment for newly transplanted lungs in order to establish a set of best practices.
The study is published in The New England Journal of Medicine.