Year: 2005
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Idiopathic pulmonary fibrosis is a chronic progressive disorder with a poor prognosis. METHODS: We conducted a double-blind, randomized, placebo-controlled multicenter study that assessed the effectiveness over one year of a high oral dose of acetylcysteine (600 mg three times daily) added to standard therapy with prednisone plus azathioprine. The primary end points were changes between baseline and month 12 in vital capacity and in single-breath carbon monoxide diffusing capacity (DL(CO)). RESULTS: A total of 182 patients were randomly assigned to treatment (92 to acetylcysteine and 90 to placebo). Of these patients, 155 (80 assigned to acetylcysteine and 75 to placebo) had usual interstitial pneumonia, as confirmed by high-resolution computed tomography and histologic findings reviewed by expert committees, and did not withdraw consent before the start of treatment. Fifty-seven of the 80 patients taking acetylcysteine (71 percent) and 51 of the 75 patients taking placebo (68 percent) completed one year of treatment. Acetylcysteine slowed the deterioration of vital capacity and DL(CO): at 12 months, the absolute differences in the change from baseline between patients taking acetylcysteine and those taking placebo were 0.18 liter (95 percent confidence interval, 0.03 to 0.32), or a relative difference of 9 percent, for vital capacity (P=0.02), and 0.75 mmol per minute per kilopascal (95 percent confidence interval, 0.27 to 1.23), or 24 percent, for DL(CO) (P=0.003). Mortality during the study was 9 percent among patients taking acetylcysteine and 11 percent among those taking placebo (P=0.69). There were no significant differences in the type or severity of adverse events between patients taking acetylcysteine and those taking placebo, except for a significantly lower rate of myelotoxic effects in the group taking acetylcysteine (P=0.03). CONCLUSIONS: Therapy with acetylcysteine at a dose of 600 mg three times daily, added to prednisone and azathioprine, preserves vital capacity and DL(CO) in patients with idiopathic pulmonary fibrosis better than does standard therapy alone.
Source: New England Journal of Medicine
DOI: 10.1056/nejmoa042976
Authors: Maurits Demedts, Juergen Behr, Roland Buhl, Ulrich Costabel, Richard Dekhuijzen, Henk M. Jansen, William MacNee, Michiel Thomeer, Benoit Wallaert, François Laurent, Andrew G. Nicholson, Eric K. Verbeken, Johny Verschakelen, Christopher D.R. Flower, Frédérique Capron, Stefano Petruzzelli, Paul De Vuyst, Jules M.M. van den Bosch, Eulogio Rodriguez-Becerra, Giuseppina Corvasce, Ida Lankhorst, Marco Sardina, Mauro Montanari
Institutions: KU Leuven, LMU Klinikum, Ludwig-Maximilians-Universität München, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Ruhrlandklinik, Amsterdam UMC Location University of Amsterdam, University of Edinburgh, Centre Hospitalier Universitaire de Lille, Hôpital Albert Calmette, Centre Hospitalier Universitaire de Bordeaux, Royal Brompton Hospital, Hôpital Antoine-Béclère, University of Pisa, Université Libre de Bruxelles, Erasmus Hospital, St. Antonius Ziekenhuis, Hospital Universitario Virgen del Rocío, Zambon (Italy)
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2125322938