Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis
Idiopathic Pulmonary Fibrosis Clinical Research Network, Fernando J Martinez, Joao A de Andrade, Kevin J Anstrom, Talmadge E King Jr, Ganesh Raghu, F J Martinez, G Raghu, M Schwarz, G B Toews, G Hunninghake, J Zibrak, A Demersky, M Vey, I O Rosas, P Debrosse, D A Culver, J Chapman, M Olman, J G Parambil, R Wehrmann, R Yadav, L D Morrison, M P Steele, T Haram, R Kidd, M Kallay, E Lyda, J H Ryu, J P Utz, A H Limper, C E Daniels, K Meiras, S Walsh, S Sahn, N O'Banner, F Stokes, K K Brown, C Bair, D Kervitsky, N A Ettinger, S Merli, G J Criner, I Q Swift, A Satti, F Cordova, N Patel, K West, G Jones, J A Lasky, S Ditta, J de Andrade, V J Thannickal, M Stewart, J Belperio, J P Lynch 3rd, E Calahan, P Lopez, T E King Jr, H R Collard, J Golden, J Lee, P Wolters, A Eller, I Noth, S White, D K Hogarth, C Brown, C Demchuk, S Holland, M Holly, G Rahimova, N Sandbo, L Sardin, M E Strek, J Roman, R Perez, T Perez, M K Glassberg, E Simonet, F J Martinez, K Baumann, K Chan, A Chughtai, B Gross, K R Flaherty, M L Han, R Hyzy, E Kazerooni, B Moore, J Myers, G B Toews, E White, D Dahlgren, C Majors, M Rossman, M Kreider, K Le, J Fitzgerald, C Glazer, M B Scholand, L Brewster, A Johnson, G Raghu, P Berry-Bell, A Snydsman, J E Loyd, L Lancaster, W Lawson, R Greer, K Kinser, R Richardson, W Mason, R J Kaner, K Bandong, R Valerio, J Tobias, D Antin-Ozerkis, C Holm, J Estrom, D A Lynch, T Colby, K J Anstrom, B Burnett, E L Eisenstein, J S Sundy, L Davidson-Ray, P Dignacco, R Edwards, R Anderson, R Beci, S Calvert, T Gentry-Bumpass, D Hill, K Hwang, J Kaur, C Matti, A Meredith, J Pesarchick, S Ramey, R S Roberts, A Sharlow, J Winsor, Q Yang, E Yow, J Kiley, G G Weinmann, H Reynolds, H Peavy, B Schmetter, X Tian, G S Davis, R Levine, S D Nathan, S Rounds, B T Thompson, B Thompson, P B Bitterman, T J Franks, S Idell, S Piantadosi, W N Rom, M Selman, D S Wilkes, Idiopathic Pulmonary Fibrosis Clinical Research Network, Fernando J Martinez, Joao A de Andrade, Kevin J Anstrom, Talmadge E King Jr, Ganesh Raghu, F J Martinez, G Raghu, M Schwarz, G B Toews, G Hunninghake, J Zibrak, A Demersky, M Vey, I O Rosas, P Debrosse, D A Culver, J Chapman, M Olman, J G Parambil, R Wehrmann, R Yadav, L D Morrison, M P Steele, T Haram, R Kidd, M Kallay, E Lyda, J H Ryu, J P Utz, A H Limper, C E Daniels, K Meiras, S Walsh, S Sahn, N O'Banner, F Stokes, K K Brown, C Bair, D Kervitsky, N A Ettinger, S Merli, G J Criner, I Q Swift, A Satti, F Cordova, N Patel, K West, G Jones, J A Lasky, S Ditta, J de Andrade, V J Thannickal, M Stewart, J Belperio, J P Lynch 3rd, E Calahan, P Lopez, T E King Jr, H R Collard, J Golden, J Lee, P Wolters, A Eller, I Noth, S White, D K Hogarth, C Brown, C Demchuk, S Holland, M Holly, G Rahimova, N Sandbo, L Sardin, M E Strek, J Roman, R Perez, T Perez, M K Glassberg, E Simonet, F J Martinez, K Baumann, K Chan, A Chughtai, B Gross, K R Flaherty, M L Han, R Hyzy, E Kazerooni, B Moore, J Myers, G B Toews, E White, D Dahlgren, C Majors, M Rossman, M Kreider, K Le, J Fitzgerald, C Glazer, M B Scholand, L Brewster, A Johnson, G Raghu, P Berry-Bell, A Snydsman, J E Loyd, L Lancaster, W Lawson, R Greer, K Kinser, R Richardson, W Mason, R J Kaner, K Bandong, R Valerio, J Tobias, D Antin-Ozerkis, C Holm, J Estrom, D A Lynch, T Colby, K J Anstrom, B Burnett, E L Eisenstein, J S Sundy, L Davidson-Ray, P Dignacco, R Edwards, R Anderson, R Beci, S Calvert, T Gentry-Bumpass, D Hill, K Hwang, J Kaur, C Matti, A Meredith, J Pesarchick, S Ramey, R S Roberts, A Sharlow, J Winsor, Q Yang, E Yow, J Kiley, G G Weinmann, H Reynolds, H Peavy, B Schmetter, X Tian, G S Davis, R Levine, S D Nathan, S Rounds, B T Thompson, B Thompson, P B Bitterman, T J Franks, S Idell, S Piantadosi, W N Rom, M Selman, D S Wilkes
Abstract
Background: Acetylcysteine has been suggested as a beneficial treatment for idiopathic pulmonary fibrosis, although data from placebo-controlled studies are lacking.
Methods: 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.
Results: 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).
Conclusions: 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.).
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Source: PubMed