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- W2891578066 abstract "An important limitation of most controlled trials is that they do not define long-term treatment outcomes. Pivotal trials of antifibrotic therapy in idiopathic pulmonary fibrosis 1 Richeldi L du Bois RM Raghu G Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014; 370: 2071-2082 Crossref PubMed Scopus (2708) Google Scholar , 2 King Jr, TE Bradford WZ Castro-Bernardini S et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014; 370: 2083-2092 Crossref PubMed Scopus (2424) Google Scholar showed that nintedanib and pirfenidone are both efficacious in slowing the 1-year rate of decline in forced vital capacity (FVC), which is widely viewed as a surrogate for mortality. However, long-term data were required, if only to address the possibility of loss of efficacy with time. In The Lancet Respiratory Medicine, Bruno Crestani and colleagues 3 Crestani B Huggins JT Kaye M et al. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2018; (published online Sept 14.)http://dx.doi.org/10.1016/S2213-2600(18)30339-4 Summary Full Text Full Text PDF Scopus (120) Google Scholar report the findings from their open-label extension study of nintedanib, which was offered to all patients completing the INPULSIS study. They provide similar data to a recent extension study of pirfenidone 4 Costabel U Albera C Lancaster LH et al. An open-label study of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (RECAP). Respiration. 2017; 94: 408-415 Crossref PubMed Scopus (91) Google Scholar , but to what extent can these findings be extrapolated to clinical practice? Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ONThese findings suggest that nintedanib has a manageable safety and tolerability profile over long-term use, with no new safety signals. Patients with idiopathic pulmonary fibrosis could use nintedanib over the long-term to slow disease progression. Full-Text PDF" @default.
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- W2891578066 date "2019-01-01" @default.
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- W2891578066 title "Efficacy data in treatment extension studies of idiopathic pulmonary fibrosis: interpret with caution" @default.
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- W2891578066 doi "https://doi.org/10.1016/s2213-2600(18)30385-0" @default.
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