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Lung disorder drug regimen found harmful

By Kathy Whitney
February 2012

The standard treatment for idiopathic pulmonary fibrosis (IPF) that has been widely used for the last 20 years is not only ineffective, but appears to be dangerous, according to the findings of a clinical trial.

As a result, the National Heart, Lung, and Blood Institute (NHLBI), an arm of the National Institutes of Health, has stopped one arm of the clinical trial known as PANTHER-IPF that was studying treatments for the disease at Vanderbilt University Medical Center and 2 dozen other sites around the country that are part of the IPF Clinical Research Network.

The trial found that a currently used triple-drug therapy consisting of prednisone, azathioprine and N-acetylcysteine (NAC) is a potentially harmful combination to people with IPF.

“This is a landmark change in treatment because it shows that a treatment that has been used widely in the U.S. and around the world does not work,” said James Loyd, M.D., professor of Medicine and Vanderbilt’s principal investigator for PANTHER-IPF.

The study data showed that compared to placebo, those assigned to triple therapy had greater mortality (11 percent vs. 1 percent), more hospitalizations (29 percent vs. 8 percent), and more serious adverse events (31 percent vs. 9 percent) and also had no improvement in lung function tests. In addition, participants randomly assigned to the triple therapy arm remained on their assigned treatment at a much lower rate (78 percent vs. 98 percent).

“It’s very important that we learn from this and move forward,” Loyd said. The combination drug therapy has not been shown to be dangerous for treating other diseases or for prevention of transplant rejection.

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