The PANTHER-IPF trial results were published recently in NEJM. The trial was to test the three-drug regimen (prednisone, azathioprine, and NAC) against NAC alone (plus matched identified placebos for prednisone and azathioprine), as compared with matched placebos for each of the active therapies, in patients with idiopathic pulmonary fibrosis who had mild-to-moderate impairment in pulmonary function.
Unfortunately, the three-drug regimen was stopped on October 14, 2011, when interim assessment found the increased deaths, hospitalizations, and serious adverse events among patients with the 3-drug regimen.
Clearly the benefit to the 3-drug regimen was lacking. Because of the combination group was stopped early, there was no assessment on the primary outcome at the end of the study. Interim analysis showed no difference in the change in FVC.
The NAC only arm is now continued.
Reference:
Idiopathic Pulmonary Fibrosis Clinical Research Network, Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med. 2012 May 24;366(21):1968-77. Epub 2012 May 20. PubMed PMID: 22607134.
http://www.nejm.org/doi/full/10.1056/NEJMoa1113354
Unfortunately, the three-drug regimen was stopped on October 14, 2011, when interim assessment found the increased deaths, hospitalizations, and serious adverse events among patients with the 3-drug regimen.
Clearly the benefit to the 3-drug regimen was lacking. Because of the combination group was stopped early, there was no assessment on the primary outcome at the end of the study. Interim analysis showed no difference in the change in FVC.
The NAC only arm is now continued.
Reference:
Idiopathic Pulmonary Fibrosis Clinical Research Network, Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med. 2012 May 24;366(21):1968-77. Epub 2012 May 20. PubMed PMID: 22607134.
http://www.nejm.org/doi/full/10.1056/NEJMoa1113354
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