And, the dramatic finding of harm from a standard treatment should cause physicians to apply rigorous testing methods to other types of treatment, and highlights the importance of independent federal funding for such studies, says Martinez.
The authors salute the volunteer IPF patients who agreed to be randomly assigned to a treatment or placebo for 60 weeks.
Martinez, an internationally known IPF researcher and clinician in the U-M Medical School's Division of Pulmonary Medicine, remarks that results will soon be known for the group taking NAC alone, compared with those taking placebo. The current paper and presentation do not include results from this group.
In the results presented this week, the authors report that eight patients in the group of 77 assigned to the three-drug combination died, compared with one in the placebo group. A total of 23 of the three-drug patients were hospitalized during the trial, compared with 7 in the placebo group. There was no sign that the three-drug combination slowed the progression of IPF or improved lung function, as measured by forced vital capacity.
The study is called PANTHER-IPF, for Prednisone, Azathioprine, and N-Acetylcysteine: a Study That Evaluates Response in Idiopathic Pulmonary Fibrosis. Except for a donation of NAC and a matched placebo by the company that makes the drug, there was no industry support for the work.
IPF, which affects nearly 100,000 Americans, slowly steals the ability to breathe freely. Its cause or causes are not clear, which is why it is called "idiopathic." Over time it leads to the buildup of scar tissue in the lungs that accumulates in a distinctive honeycomb pattern that can be seen on biopsy or CT scan. It is known as an interstitial lung disease because it affects the tissue around the air sacs in the lungs.
IPF patients live an average of five years after diagnosis, though a lung t
|Contact: Kara Gavin|
University of Michigan Health System