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Cited by 1,621

The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.

Prednisone, Azathioprine, and N -Acetylcysteine for Pulmonary Fibrosis

Open access
The Idiopathic Pulmonary Fibrosis Clinical Research Network·2012·New England Journal of Medicine

Abstract

BACKGROUND: A combination of prednisone, azathioprine, and N-acetylcysteine (NAC) has been widely used as a treatment for idiopathic pulmonary fibrosis. The safety and efficacy of this three-drug regimen is unknown. METHODS: In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups -- receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo -- in a 1:1:1 ratio. The primary outcome was the change in longitudinal measurements of forced vital capacity during a 60-week treatment period. RESULTS: When approximately 50% of data had been collected (with 77 patients in the combination-therapy group and 78 in the placebo group), a planned interim analysis revealed that patients in the combination-therapy group, as compared with the placebo group, had an increased rate of death (8 vs. 1, P=0.01) and hospitalization (23 vs. 7, P<0.001). These observations, coupled with no evidence of physiological or clinical benefit for combination therapy, prompted the independent data and safety monitoring board to recommend termination of the combination-therapy group at a mean follow-up of 32 weeks. Data from the ongoing comparison of the NAC-only group and the placebo group are not reported here. CONCLUSIONS: Increased risks of death and hospitalization were observed in patients with idiopathic pulmonary fibrosis who were treated with a combination of prednisone, azathioprine, and NAC, as compared with placebo. These findings provide evidence against the use of this combination in such patients. (Funded by the National Heart, Lung, and Blood Institute and the Cowlin Family Fund; ClinicalTrials.gov number, NCT00650091.).

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Metadata

Authors
The Idiopathic Pulmonary Fibrosis Clinical Research Network
Venue
New England Journal of Medicine
Published
2012-05-24
Volume
366
Issue
21
Pages
1968-1977
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2098305693
Cited by
1,621
References
5
FWCI
77.55
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Prednisone, Azathioprine, and N -Acetylcysteine for Pulmonary Fibrosis. https://app.cochat.ai/papers/10.1056/nejmoa1113354
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The Idiopathic Pulmonary Fibrosis Clinical Research Network. (2012). Prednisone, Azathioprine, and N -Acetylcysteine for Pulmonary Fibrosis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1113354

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.