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Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomized on NAC Cost-Utility Study, BRONCUS): a randomised placebo-controlled trial

Increased oxidative stress is important in the pathogenesis of chronic obstructive pulmonary disease (COPD). We postulated that treatment with the antioxidant N-acetylcysteine would reduce the rate of lung-function decline, reduce yearly exacerbation rate, and improve outcomes. In a randomised place...

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Published in:The Lancet (British edition) 2005-04, Vol.365 (9470), p.1552-1560
Main Authors: Decramer, Marc, Rutten-van Mölken, Maureen, Dekhuijzen, PN Richard, Troosters, Thierry, van Herwaarden, Cees, Pellegrino, Riccardo, van Schayck, CP Onno, Olivieri, Dario, Del Donno, Mario, De Backer, Wilfried, Lankhorst, Ida, Ardia, Alfredo
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Language:English
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Summary:Increased oxidative stress is important in the pathogenesis of chronic obstructive pulmonary disease (COPD). We postulated that treatment with the antioxidant N-acetylcysteine would reduce the rate of lung-function decline, reduce yearly exacerbation rate, and improve outcomes. In a randomised placebo-controlled study in 50 centres, 523 patients with COPD were randomly assigned to 600 mg daily N-acetylcysteine or placebo. Patients were followed for 3 years. Primary outcomes were yearly reduction in forced expiratory volume in 1 s (FEV 1) and the number of exacerbations per year. Analysis was by intention to treat. The yearly rate of decline in FEV 1 did not differ between patients assigned N-acetylcysteine and those assigned placebo (54 mL [SE 6] vs 47 mL [6]; difference in slope between groups 8 mL [9]; 95% CI −25 to 10). The number of exacerbations per year did not differ between groups (1·25 [SD 1·35] vs 1·29 [SD 1·46]; hazard ratio 0·99 [95% CI 0·89–1·10, p=0·85]). Subgroup analysis suggested that the exacerbation rate might be reduced with N acetylcysteine in patients not treated with inhaled corticosteroids and secondary analysis was suggestive of an effect on hyperinflation. N-acetylcysteine is ineffective at prevention of deterioration in lung function and prevention of exacerbations in patients with COPD.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(05)66456-2