Please use this identifier to cite or link to this item: http://repositorio.unifesp.br/handle/11600/49680
Title: Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials
Authors: Noble, Paul W.
Albera, Carlo
Bradford, Williamson Z.
Costabel, Ulrich
du Bois, Roland M.
Fagan, Elizabeth A.
Fishman, Robert S.
Glaspole, Ian
Glassberg, Marilyn K.
Lancaster, Lisa
Lederer, David J.
Leff, Jonathan A.
Nathan, Steven D.
Pereira, Carlos A. [UNIFESP]
Swigris, Jeffrey J.
Valeyre, Dominique
King, Talmadge E., Jr.
Issue Date: 2016
Publisher: European Respiratory Soc Journals Ltd
Citation: European Respiratory Journal. Sheffield, v. 47, n. 1, p. 243-253, 2016.
Abstract: Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression. All patients randomised to pirfenidone 2403 mg . day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the prespecified end-points and analytic methods described in the ASCEND study protocol. A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a. 10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation. Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.
URI: http://repositorio.unifesp.br/handle/11600/49680
ISSN: 0903-1936
Other Identifiers: http://dx.doi.org/10.1183/13993003.00026-2015
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