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http://hdl.handle.net/1942/31744
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DC Field | Value | Language |
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dc.contributor.author | Demedts, M | - |
dc.contributor.author | Behr, J | - |
dc.contributor.author | Buhl, R | - |
dc.contributor.author | Costabel, U | - |
dc.contributor.author | Dekhuijzen, R | - |
dc.contributor.author | Jansen, HM | - |
dc.contributor.author | MacNee, W | - |
dc.contributor.author | THOMEER, Michiel | - |
dc.contributor.author | Wallaert, B | - |
dc.contributor.author | Laurent, F | - |
dc.contributor.author | Nicholson, AG | - |
dc.contributor.author | Verbeken, EK | - |
dc.contributor.author | Verschakelen, J | - |
dc.contributor.author | Flower, CDR | - |
dc.contributor.author | Capron, F | - |
dc.contributor.author | Petruzzelli, S | - |
dc.contributor.author | De Vuyst, P | - |
dc.contributor.author | van den Bosch, JMM | - |
dc.contributor.author | Rodriguez-Becerra, E | - |
dc.contributor.author | Corvasce, G | - |
dc.contributor.author | Lankhorst, I | - |
dc.contributor.author | Sardina, M | - |
dc.contributor.author | Montanari, M | - |
dc.date.accessioned | 2020-08-17T12:03:15Z | - |
dc.date.available | 2020-08-17T12:03:15Z | - |
dc.date.issued | 2005 | - |
dc.date.submitted | 2020-08-17T11:57:02Z | - |
dc.identifier.citation | The New England journal of medicine (Print), 353 (21) , p. 2229 -2242 | - |
dc.identifier.uri | http://hdl.handle.net/1942/31744 | - |
dc.description.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(sub 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(sub 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(sub 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(sub CO) in patients with idiopathic pulmonary fibrosis better than does standard therapy alone. | - |
dc.description.sponsorship | We are indebted to Professor E. Lesaffre and his collaborators at the Biostatistics Center of the Katholieke Universiteit Leuven for statistical advice and assistance, and to Professor R. du Bois and Professor A. Wells from the Interstitial Lung Disease Unit of the Royal Brompton Hospital in London and to Professor T. Fleming from the Biostatistics Department of the University of Washington, Seattle, for their valuable comments. Supported by the Zambon Group. Dr. Demedts reports having received consulting fees from Zambon, Wyeth, and Roche and lecture fees from GlaxoSmithKline, AstraZeneca, and Zambon; Dr. Behr, consulting fees from Zambon and Actelion and lecture fees from Zambon, Actelion, GlaxoSmithKline, and AstraZeneca; Dr. Buhl, consulting fees from Zambon and lecture fees from ALTANA, AstraZeneca, Bayer, Boehringer Ingelheim, Fujisawa, GlaxoSmithKline, Novartis, Merck Sharpe & Dohme, Pfizer, Schering-Plough, and Zambon; Dr. Costabel, consulting fees from InterMune, Centocor, and Zambon and lecture fees from InterMune; Dr. Jansen, consulting fees from Zambon; Dr. MacNee, consulting fees from Pfizer, lecture fees from Zambon, GlaxoSmithKline, AstraZeneca, and Pfizer, and grant support from Chugai Pharma Europe, GlaxoSmithKline, SMB Pharmaceuticals, and CereMedix; Dr. Thomeer, consulting fees from Zambon and InterMune and lecture fees from Zambon, InterMune, AstraZeneca, and GlaxoSmithKline; Dr. Wallaert, lecture fees from Merck Sharpe & Dohme, Chiron, and GlaxoSmithKline; Dr. Laurent, consulting fees from Zambon; Dr. Nicholson, consulting fees from Zambon and lecture fees from AstraZeneca; Dr. Verbeken, consulting fees from Zambon; Dr. Verschakelen, consulting fees from Zambon; Dr. Flower, consulting fees from Zambon; Dr. Capron, consulting fees from Zambon; Dr. De Vuyst, consulting fees from GlaxoSmithKline and lecture fees from AstraZeneca and Boehringer Ingelheim; Dr. Rodriguez-Becerra, lecture fees from Zambon; and Dr. Montanari, statistical consulting fees from Zambon. Dr. Corvasce is a former employee and Dr. Sardina a current employee of Zambon; Dr. Lankhorst reports having received consulting fees from Zambon and was formerly employed by Zambon. | - |
dc.language.iso | en | - |
dc.publisher | MASSACHUSETTS MEDICAL SOC | - |
dc.rights | 2005 Massachusetts Medical Society. All rights reserved. | - |
dc.title | High-dose acetylcysteine in idiopathic pulmonary fibrosis | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 2242 | - |
dc.identifier.issue | 21 | - |
dc.identifier.spage | 2229 | - |
dc.identifier.volume | 353 | - |
local.bibliographicCitation.jcat | A1 | - |
local.publisher.place | WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1056/NEJMoa042976 | - |
dc.identifier.isi | WOS:000233434500006 | - |
local.provider.type | Web of Science | - |
item.fulltext | With Fulltext | - |
item.fullcitation | Demedts, M; Behr, J; Buhl, R; Costabel, U; Dekhuijzen, R; Jansen, HM; MacNee, W; THOMEER, Michiel; Wallaert, B; Laurent, F; Nicholson, AG; Verbeken, EK; Verschakelen, J; Flower, CDR; Capron, F; Petruzzelli, S; De Vuyst, P; van den Bosch, JMM; Rodriguez-Becerra, E; Corvasce, G; Lankhorst, I; Sardina, M & Montanari, M (2005) High-dose acetylcysteine in idiopathic pulmonary fibrosis. In: The New England journal of medicine (Print), 353 (21) , p. 2229 -2242. | - |
item.accessRights | Restricted Access | - |
item.contributor | Demedts, M | - |
item.contributor | Behr, J | - |
item.contributor | Buhl, R | - |
item.contributor | Costabel, U | - |
item.contributor | Dekhuijzen, R | - |
item.contributor | Jansen, HM | - |
item.contributor | MacNee, W | - |
item.contributor | THOMEER, Michiel | - |
item.contributor | Wallaert, B | - |
item.contributor | Laurent, F | - |
item.contributor | Nicholson, AG | - |
item.contributor | Verbeken, EK | - |
item.contributor | Verschakelen, J | - |
item.contributor | Flower, CDR | - |
item.contributor | Capron, F | - |
item.contributor | Petruzzelli, S | - |
item.contributor | De Vuyst, P | - |
item.contributor | van den Bosch, JMM | - |
item.contributor | Rodriguez-Becerra, E | - |
item.contributor | Corvasce, G | - |
item.contributor | Lankhorst, I | - |
item.contributor | Sardina, M | - |
item.contributor | Montanari, M | - |
crisitem.journal.issn | 0028-4793 | - |
crisitem.journal.eissn | 1533-4406 | - |
Appears in Collections: | Research publications |
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45651_207328y.pdf Restricted Access | Published version | 220.24 kB | Adobe PDF | View/Open Request a copy |
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