Safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF): Integrated analysis of cumulative data from 5 clinical trials
U Costabel, L Lancaster, C Albera, WZ Bradford, EA Fagan, R Fishman, I Glaspole, MK Glassberg, TE King, DJ Lederer, Z Lin, SD Nathan, CA Pereira, JJ Swigris, D Valeyre, PW Noble · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Rationale: IPF is a chronic, progressive disease that requires long-term treatment. To evaluate the clinical safety of pirfenidone (PFD) in IPF, we performed a comprehensive integrated analysis of safety data from 5 clinical trials. Methods: All patients treated with PFD 2403 mg/d in the Phase 3 multinational studies (Ph.3: 004, 006, and 016) and all patients receiving at least one dose of PFD in the ongoing open-label studies (002 and 012) comprised the integrated population. Interim data cut was on January 15, 2014. Cumulative safety outcomes in the pooled PFD 2403 mg/d and placebo (PBO) groups in Ph. 3 are pr…
