title: Analysis of lung function and survival in RECAP: An open-label extension study of pirfenidone in patients with idiopathic pulmonary fibrosis.
abstract: BACKGROUND
  RECAP is an open-label extension study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) who completed the Phase 3 CAPACITY program.
  
  
  OBJECTIVE
  We examined the effect of pirfenidone on lung function and survival in patients who were previously randomised to the placebo group in one of the two CAPACITY studies and received pirfenidone for the first time in RECAP.
  
  
  METHODS
  Eligible patients received oral pirfenidone 2403 mg/day. Forced vital capacity (FVC) was measured at baseline and at weeks 12, 36, and 60. To facilitate comparison with CAPACITY outcomes, analyses were based on patients newly treated with pirfenidone in RECAP who had baseline FVC and carbon monoxide diffusing capacity (DLCO) values that met CAPACITY entry criteria.
  
  
  RESULTS
  A total of 178 patients were included in the analysis. Among these, 16.3% experienced an FVC decline ≥10% at week 60, compared with 16.8% and 24.8%, respectively, in the CAPACITY pirfenidone (n=345) and placebo (n=347) groups. The mean change from baseline to week 60 in %FVC was -5.9%, compared with -7.0% and -9.4% in the CAPACITY pirfenidone and placebo groups. Overall survival was similar to that of pirfenidone treated patients in CAPACITY. Treatment was safe and generally well tolerated; the type and frequency of adverse events were consistent with previous clinical experience.
  
  
  CONCLUSIONS
  FVC and survival outcomes in IPF patients newly treated with pirfenidone in RECAP were similar to those in the CAPACITY pirfenidone group. These data provide further evidence to support the use of pirfenidone in patients with IPF.
authors.affiliation: Ruhrlandklinik, University Hospital, University Duisburg-Essen, Essen, Germany. Ulrich.Costabel@ruhrlandklinik.uk-essen.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.forename: Carlo
authors.initials: C
authors.lastname: Albera
authors.forename: Williamson Z
authors.initials: WZ
authors.lastname: Bradford
authors.forename: Phil
authors.initials: P
authors.lastname: Hormel
authors.forename: Talmadge E
authors.initials: TE
authors.lastname: King
authors.forename: Paul W
authors.initials: PW
authors.lastname: Noble
authors.forename: Steven A
authors.initials: SA
authors.lastname: Sahn
authors.forename: Dominique
authors.initials: D
authors.lastname: Valeyre
authors.forename: Roland M
authors.initials: RM
authors.lastname: du Bois
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001315:Australia; D018450:Disease Progression; D005060:Europe; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D008168:Lung / Q000187:drug effects* / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009656:North America; D011446:Prospective Studies; D011653:Pulmonary Diffusing Capacity; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000893:Anti-Inflammatory Agents; D011728:Pyridones; C093844:pirfenidone