Reduction in disease progression with nintedanib in the INPULSIS™ trials
M Kreuter, V Cottin, H Taniguchi, HR Collard, L Richeldi, S Stowasser, I Tschoepe, R Schlenker-Herceg, G Raghu · Pneumologie · 2015 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: Nintedanib, an intracellular inhibitor of tyrosine kinases, is in development for the treatment of idiopathic pulmonary fibrosis (IPF). The INPULSIS™ trials were two replicate 52-week, randomized, double-blind, placebo-controlled Phase III trials that investigated the efficacy and safety of nintedanib 150 mg twice daily in 1066 patients with IPF. Declines in forced vital capacity (FVC) % predicted of > 5% and > 10% in patients with IPF have been proposed as indicators of disease progression and have been associated with reduced survival. Aim: To determine the effect of nintedanib on changes in FVC %…