Effect of continued treatment with pirfenidone following a clinically meaningful decline in percent predicted forced vital capacity in patients with idiopathic pulmonary fibrosis…
U Costabel, SD Nathan, C Albera, WZ Bradford, EA Fagan, I Glaspole, MK Glassberg, TE King, L Lancaster, DJ Lederer, Z Lin, CA Pereira, JJ Swigris, D Valeyre, PW Noble · Pneumologie · 2016 · Heft 02
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Zusammenfassung
Background: IPF shows substantial inter- and intra-subject variability in the rates of disease progression, confounding the assessment of therapeutic response in an individual patient. The present analysis used pooled data from three Phase 3 trials to assess the potential benefit of continued treatment with pirfenidone (PFD) in patients who experience a ≥10% decline in forced vital capacity (% FVC) in first 6 months of treatment. Methods: Source data included all patients randomized to PFD 2403 mg/d or placebo (PBO) in the ASCEND or CAPACITY studies (N = 1247). From these, we selected all patients with a ≥10% ab…