Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. Academic Article Article uri icon

Overview

MeSH

  • Aged
  • Azathioprine
  • Disease Progression
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Prednisone
  • Treatment Failure
  • Vital Capacity

MeSH Major

  • Acetylcysteine
  • Free Radical Scavengers
  • Idiopathic Pulmonary Fibrosis

abstract

  • Acetylcysteine has been suggested as a beneficial treatment for idiopathic pulmonary fibrosis, although data from placebo-controlled studies are lacking. 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. 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). 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.).

publication date

  • May 29, 2014

has subject area

  • Acetylcysteine
  • Aged
  • Azathioprine
  • Disease Progression
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Free Radical Scavengers
  • Humans
  • Idiopathic Pulmonary Fibrosis
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Prednisone
  • Treatment Failure
  • Vital Capacity

Research

keywords

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Identity

Language

  • eng

PubMed Central ID

  • PMC4116664

Digital Object Identifier (DOI)

  • 10.1056/NEJMoa1401739

PubMed ID

  • 24836309

Additional Document Info

start page

  • 2093

end page

  • 2101

volume

  • 370

number

  • 22