(Ivanhoe Newswire) – There has always been a large focus on testing new treatments for cancer and disease, but a new study on Idiopathic pulmonary fibrosis (IPF) sheds light on the importance of testing standard treatment, as it could present fatal risks as well.
IPF is a progressive lung-scarring disease that affects nearly 100,000 Americans and robs the patients’ ability to breathe freely. Its causes are not clear, making it an "idiopathic" disease, and it is considered "interstitial" because it affects the tissue around the air sacs in the lungs. The standard care to treat IPF consists of a combination of three drugs: Prednisone, Azathioprine, and N-Acetylcysteine.
The study was conducted by the IPF Clinical Research Network and funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health; it is called Panther-IPF, for Prednisone, Azathioprine, and N-Acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis. It was a randomized, double-blind, placebo-controlled federally funded trial that included patients who were definitively diagnosed with IPF and were being treated at 25 centers taking part in the IPF Clinical Research Network or IPFNet.
The outcome of the study provokes much discussion, as it had to be stopped early when an interim analysis showed harm from the combination of the three drugs.
In the group who took the three-drug combination, eight of the 77 patients died, compared with one in the placebo group. 23 of the three-drug group were hospitalized during the trial, compared to 7 in the placebo group.
It was found that patients in the mild to moderate stages of the disease had a far higher chance of dying or being hospitalized after taking the three-drug combination compared with those patients taking the placebo. Additionally, the three-drug combo showed no improvement in lung function, nor did it slow the loss of lung function. Group results from single use of the drug N-Acetylcysteine are still being gathered and analyzed, and the results will soon be known.
"The findings show the importance of testing even those treatments that doctors give routinely for any type of condition- to see if they truly help, and don’t harm, patients," Fernando Martinez, M.D. University of Michigan Health System lung specialist and study results presenter was quoted as saying.
Martinez was also quoted as saying that this combination of drugs should not be used to treat IPF patients anymore, and this study highlights the importance of independent federal funding for studies that analyze routine procedures.
Source: New England Journal of Medicine, in conjunction with American Thoracic Society Meeting, May 2012