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Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis.

Publication ,  Journal Article
Idiopathic Pulmonary Fibrosis Clinical Research Network, ; Martinez, FJ; de Andrade, JA; Anstrom, KJ; King, TE; Raghu, G
Published in: N Engl J Med
May 29, 2014

BACKGROUND: Acetylcysteine has been suggested as a beneficial treatment for idiopathic pulmonary fibrosis, although data from placebo-controlled studies are lacking. METHODS: In our initial double-blind, placebo-controlled trial, we randomly assigned patients who had idiopathic pulmonary fibrosis with mild-to-moderate impairment in pulmonary function to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine alone; or placebo. The study was interrupted owing to safety concerns associated with the three-drug regimen. The trial continued as a two-group study (acetylcysteine vs. placebo) without other changes; 133 and 131 patients were enrolled in the acetylcysteine and placebo groups, respectively. The primary outcome was the change in forced vital capacity (FVC) over a 60-week period. RESULTS: At 60 weeks, there was no significant difference in the change in FVC between the acetylcysteine group and the placebo group (-0.18 liters and -0.19 liters, respectively; P=0.77). In addition, there were no significant differences between the acetylcysteine group and the placebo group in the rates of death (4.9% vs. 2.5%, P=0.30 by the log-rank test) or acute exacerbation (2.3% in each group, P>0.99). CONCLUSIONS: As compared with placebo, acetylcysteine offered no significant benefit with respect to the preservation of FVC in patients with idiopathic pulmonary fibrosis with mild-to-moderate impairment in lung function. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00650091.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 29, 2014

Volume

370

Issue

22

Start / End Page

2093 / 2101

Location

United States

Related Subject Headings

  • Vital Capacity
  • Treatment Failure
  • Prednisone
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Idiopathic Pulmonary Fibrosis
  • Humans
  • General & Internal Medicine
  • Free Radical Scavengers
 

Citation

APA
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Idiopathic Pulmonary Fibrosis Clinical Research Network, ., Martinez, F. J., de Andrade, J. A., Anstrom, K. J., King, T. E., & Raghu, G. (2014). Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med, 370(22), 2093–2101. https://doi.org/10.1056/NEJMoa1401739
Idiopathic Pulmonary Fibrosis Clinical Research Network, Ganesh, Fernando J. Martinez, Joao A. de Andrade, Kevin J. Anstrom, Talmadge E. King, and Ganesh Raghu. “Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis.N Engl J Med 370, no. 22 (May 29, 2014): 2093–2101. https://doi.org/10.1056/NEJMoa1401739.
Idiopathic Pulmonary Fibrosis Clinical Research Network, Martinez FJ, de Andrade JA, Anstrom KJ, King TE, Raghu G. Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2093–101.
Idiopathic Pulmonary Fibrosis Clinical Research Network, Ganesh, et al. “Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis.N Engl J Med, vol. 370, no. 22, May 2014, pp. 2093–101. Pubmed, doi:10.1056/NEJMoa1401739.
Idiopathic Pulmonary Fibrosis Clinical Research Network, Martinez FJ, de Andrade JA, Anstrom KJ, King TE, Raghu G. Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2093–2101.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 29, 2014

Volume

370

Issue

22

Start / End Page

2093 / 2101

Location

United States

Related Subject Headings

  • Vital Capacity
  • Treatment Failure
  • Prednisone
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Idiopathic Pulmonary Fibrosis
  • Humans
  • General & Internal Medicine
  • Free Radical Scavengers