Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis.

ABSTRACT:

Background and objective

Pirfenidone is an oral antifibrotic agent that is approved in several countries for the treatment of idiopathic pulmonary fibrosis (IPF). We performed a comprehensive analysis of safety across four clinical trials evaluating pirfenidone in patients with IPF.

Methods

All patients receiving pirfenidone 2403 mg/day in the Phase 3 CAPACITY studies (Studies 004 and 006) and all patients receiving at least one dose of pirfenidone in one of two ongoing open-label studies in patients with IPF (Studies 002 and 012) were selected for inclusion. Safety outcomes were evaluated from baseline until 28 days after the last dose of study drug.

Results

A total of 789 patients were included in the analysis. The median duration of exposure to pirfenidone was 2.6

SUBMITTER: Valeyre D 

PROVIDER: S-EPMC4230393 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature