Forced Vital Capacity in Idiopathic Pulmonary Fibrosis — FDA Review of Pirfenidone and Nintedanib  

Oleh:

Karimi-Shah, Banu A. ; Chowdhury, Badrul A.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 372 no. 13 (Mar. 2015), page 1189-1191.

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Perpustakaan FK Nomor Panggil: N08.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Idiopathic pulmonary fibrosis (IPF) is a devastating disease of unknown cause, and for years the only effective treatment available was lung transplantation. In October 2014, two drugs became available in the United States for patients with IPF when the Food and Drug Administration (FDA) approved pirfenidone (Esbriet, InterMune) and nintedanib (Ofev, Boehringer Ingelheim).1 Both drugs posed a similar regulatory challenge, in that the primary efficacy variable studied in both cases was the change in forced vital capacity (FVC). FVC, a measure of lung function, had not been established as a surrogate for clinically meaningful benefit in IPF.

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