Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis.

ABSTRACT: We assessed safety and tolerability of treatment with pirfenidone (1602-2403 mg·day^-1) and nintedanib (200-300 mg·day^-1) in patients with idiopathic pulmonary fibrosis (IPF).This 24-week, single-arm, open-label, phase IV study (ClinicalTrials.gov identifier NCT02598193) enrolled patients with IPF with forced vital capacity % pred ≥50% and diffusing capacity of the lung for carbon monoxide % pred ≥30%. Before initiating nintedanib, patients had received pirfenidone for ≥16 weeks and tolerated a stable dose of ≥1602 mg·day^-1 for ≥28 days. The primary end-point was the proportion of patients who completed 24 weeks of combination treatment on pirfenidone (1602-2403 mg·day^-1) and nintedanib (200-300 mg·day^-1). Investigators recorded treatme

SUBMITTER: Flaherty KR 

PROVIDER: S-EPMC6092682 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature