Efficacy of Pirfenidone in the Context of Multiple Disease Progression Events in Patients With Idiopathic Pulmonary Fibrosis

Declines in percent predicted FVC (% predicted FVC), declines in 6-min walk distance (6MWD), and respiratory hospitalizations are events associated with disease progression and mortality in idiopathic pulmonary fibrosis. The incidence of multiple events in the same patient over 12 months of pirfenid...

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Veröffentlicht in:Chest 2019-04, Vol.155 (4), p.712-719
Hauptverfasser: Nathan, Steven D., Costabel, Ulrich, Glaspole, Ian, Glassberg, Marilyn K., Lancaster, Lisa H., Lederer, David J., Pereira, Carlos A., Trzaskoma, Benjamin, Morgenthien, Elizabeth A., Limb, Susan L., Wells, Athol U.
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container_end_page 719
container_issue 4
container_start_page 712
container_title Chest
container_volume 155
creator Nathan, Steven D.
Costabel, Ulrich
Glaspole, Ian
Glassberg, Marilyn K.
Lancaster, Lisa H.
Lederer, David J.
Pereira, Carlos A.
Trzaskoma, Benjamin
Morgenthien, Elizabeth A.
Limb, Susan L.
Wells, Athol U.
description Declines in percent predicted FVC (% predicted FVC), declines in 6-min walk distance (6MWD), and respiratory hospitalizations are events associated with disease progression and mortality in idiopathic pulmonary fibrosis. The incidence of multiple events in the same patient over 12 months of pirfenidone treatment is unknown. Patients who received pirfenidone 2,403 mg/d (n = 623) or placebo (n = 624) in the ASCEND (study 016; NCT01366209) and CAPACITY (studies 004 and 006; NCT00287716 and NCT00287729) phase III trials were included in this post hoc analysis. Disease progression events were defined as relative decline in % predicted FVC ≥ 10%, absolute decline in 6MWD ≥ 50 m, respiratory hospitalization, or death from any cause. The incidence of disease progression events over 12 months was assessed. The most frequent disease progression events were declines in % predicted FVC (pirfenidone vs placebo; 202 vs 304 events) and declines in 6MWD (pirfenidone vs placebo; 265 vs 348 events). Fewer patients who received pirfenidone had more than one progression event compared with placebo (17.0% vs 30.1%; P < .0001). Death following one or more progression event occurred less frequently in the pirfenidone group than in the placebo group (2.1% vs 6.3%; P = .0002). Pirfenidone significantly reduced the incidence of multiple progression events and death after a progression event over 12 months of treatment compared with placebo. These findings suggest that continued treatment with pirfenidone confers a benefit despite the occurrence of any single disease progression event. ClinicalTrials.gov; Nos. NCT01366209, NCT00287716, and NCT00287729; URL: www.clinicaltrials.gov.
doi_str_mv 10.1016/j.chest.2018.11.008
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subjects Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Cause of Death - trends
Disease Progression
Dose-Response Relationship, Drug
Europe - epidemiology
Female
Follow-Up Studies
Humans
idiopathic pulmonary fibrosis
Idiopathic Pulmonary Fibrosis - diagnosis
Idiopathic Pulmonary Fibrosis - drug therapy
Idiopathic Pulmonary Fibrosis - mortality
interstitial lung diseases
Male
Middle Aged
pirfenidone
Pyridones - administration & dosage
Survival Rate - trends
Treatment Outcome
United States - epidemiology
Vital Capacity
title Efficacy of Pirfenidone in the Context of Multiple Disease Progression Events in Patients With Idiopathic Pulmonary Fibrosis
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