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Title: High-dose acetylcysteine in idiopathic pulmonary fibrosis
Authors: Demedts, Maurice
Behr, Juergen
Buhl, Roland
Costabel, Ulrich
Dekhuijzen, Richard
Jansen, Henk M
MacNee, William
Thomeer, Michiel
Wallaert, Benoit
Laurent, François
Nicholson, Andrew G
Verbeken, Eric
Verschakelen, Johny
Flower, Christopher D R
Capron, Frédérique
Petruzzelli, Stefano
De Vuyst, Paul
van den Bosch, Jules M M
Rodriguez-Becerra, Eulogio
Corvasce, Giuseppina
Lankhorst, Ida
Sardina, Marco
Montanari, Mauro #
Issue Date: Nov-2005
Publisher: Massachusetts medical soc
Series Title: The New England Journal of Medicine vol:353 issue:21 pages:2229-42
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.
URI: 
ISSN: 0028-4793
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Pneumology
Translational Cell & Tissue Research
Radiology
# (joint) last author

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